CML Advocates Network

Study title

ENESTPath = A Study to Assess the Effect of a Longer Duration of Consolidation Treatment With Nilotinib on TFR in CP CML [Europe]

Scientific title

A Prospective, Randomized, Open Label, Two Arm Phase III Study to Evaluate Treatment Free Remission (TFR) Rate in Patients With Philadelphia-positive CML After Two Different Durations of Consolidation Treatment With Nilotinib 300mg BID (EudraCT 2012-005124-15), ClinicalTrials.govNCT01743989)

Indication and most important inclusion criteria

Chronic myeloid leukemia (CML)
Patients with a confirmed diagnosis of chronic phase Ph+ CML and with previous first-line treatment with imatinib for at least 2 years; patients should have achieved complete cytogenetic response (CCyR), and should have MR <4.0 at study entry.

Short description of intervention

Changing patients with chronic phase CML (MMR / less than MR4.0) from imatinib to nilotinib (randomized over 2 for 3 years) with the aim of stopping nilotinib in patients with a good response (MR4.0 or better).

Type of studyTreatment free remission

Treatment free remission

Current status

Recruitment completed

The first patients entered the treatment free remission phase in June 2015.

Study sponsor

Novartis Pharma AG

Scientific lead / contact

Luca Dezzani
Angela Pellegrino

Principal investigator

Michele Baccarani
University of Bologna, Italy

Additional information

• Study description in the EU Clinical Trials Register,  which is hosted by the European Medicines Agency (EMA)
• Study description in US register ClinicalTrials.gov, a service of the U.S. National Institutes of Health
• Short protocol in Kompetenznetz Leukämien
• ENESTPath Patient Information Brochure

Study centers

Austria
Graz
LKH Graz Med. Universität Klinik

Innsbruck
Universitätsklinik Innsbruck

Linz
Allgem. öffentl. Krankenhaus der Stadt Linz

Linz
Krankenhaus der Barmherzigen Schwestern

Linz
Krankenhaus der Elisabethinen Linz

Rankweil
Landeskrankenhaus Rankweil

Salzburg
LKH Salzburg / Univ.Klinikum der Paracelsus MPU

Wien
Hanusch-Krankenhaus

Wien
Krankenhaus der Stadt Wien-Hietzing

Belgium
Bruxelles
Cliniques Universitaires Saint-Luc

Edegem
U.Z. Antwerpen

Haine-saint-Paul
CH Jolimont-Lobbes

Kortrijk
AZ Groeninge - Campus Maria's voorzienigheid

Liege
Clinique Saint-Joseph

Tournai
CH WAPI - Site Notre Dame

Bulgaria
Pleven
MHAT "Dr. George Stranski"

Plovdiv
Multifunctional Hospital for Active Treatment "St. George"

Sofia
Alexandrovska University Hospital

Sofia
Specialized Hospital for Active Treatment of Haematological

Varna
Multifunctional Hospital for Active Treatment "Sveta Marina"


Czech Republic
Brno – Bohunice
FN Brno - Bohunice


Denmark
Holstebro
Regionshospitalet Vest Holstebro


Finland
HUS Helsinki
Hematologian tutkimusyksikkö

Turku
TYKS


France
Amiens cedex1
CHU d'Amiens - Hôpital Sud

Angers Cedex 1
CHU d'Angers

Argenteuil Cedex
CHU d'Angers

Auch
Centre Hospitalier General D'auch

Avignon cedex 9
Centre Hospitalier d'Avignon

Bayonne cedex
Centre Hospitalier de la Côte Basque

Besancon cedex
CHU Jean Minjoz

Bordeaux
Institut Bergonie

Bordeaux Cedex
Polyclinique Bordeaux Nord

Brest
CHU de Brest - Hôpital Morvan

Brive la Gaillard
Centre Hospitalier de Brive

Caen cedex
Centre Francois Baclesse

Caen cedex
CHU de Caen

Chalon sur Saône
Centre Hospitalier William Morey

Chambéry cedex
Centre Hospitalier de Chambéry

Clermont Ferrand cedex 1
CHU de Clermont-Ferrand - Hôpital d'Estaing

Corbeil Essonnes
Centre Hospitalier Sud Francilien

Créteil
Centre Hospitalier Henri Mondor

Dunkerque
CHU Dunkerque

Grenoble
Hôpital Albert Michallon

La Roche sur Yon cedex 9
CHD Les Oudairies

Le Chesnay
Hôpital A. Mignot

Le Kremlin Bicetre
Hôpital Kremlin Bicetre

Le Mans cedex 09
Centre Hospitalier Le Mans

Libourne
Hopital Robert Boulin

Lille
CHRU Claude Huriez

Lille cedex
Hôpital Saint Vincent

Limoges cedex
Centre Hospitalier de Limoges

Lorient
Centre Hospitalier Bretagne Sud site de Lorient

Lyon Cedex
Centre Léon Bérard

Marseille
AP-HM - Hôpital de la Conception

Marseille Cédex 9
Institut Paoli Calmettes

Metz cedex 03
CHR Metz Thionville

Montpellier cedex 5
CHRU de Montpellier - Hôpital Saint Eloi

Mulhouse cedex
C H de Mulhouse - Hôpital Emile Muller

Nantes
Hopital Hotel Dieu

Nice Cedex
CHU de Nice Hôp. de l'Archet 1

Orleans
CHR Orleans

Paris
Hopital Saint Antoine

Paris Cedex 10
Hôpital Saint Louis

Paris
Hôpital Necker - Enfants Malades

Paris Cedex 13
Groupe Hospitalier Pitie-Salpetriere

Paris Cedex 14
Hôpital Cochin

Perpignan
CH de Perpignan

Pessac
Hôpital du Haut-Lévêque

Pierre-Benite Cédex
Centre Hospitalier Lyon-Sud

Poitiers
CHU Poitiers

Pontoise
Centre Hospitalier Rene Dubos

Pringy cedex
Centre Hospitalier de la Région d'Annecy

Reims
Hôpital Robert Debré

Rennes
CHRU de Rennes

Rouen Cedex 1
Centre Henri Becquerel-CLCC Hte Normandie

Saint Brieuc cedex 1
CH de Saint-Brieuc - Hôpital Yves Le Foll

Saint-Priest-en-Jarez
Institut de Cancérologie Lucien Neuwirth

Strasbourg cedex
HUS - Hôpital Civil

Strasbourg cedex
G H St Vincent-Clinique Ste Anne

Toulouse cedex 9
CHU de Toulouse - Hôpital Purpan

Toulouse cedex 9
Clinique Pasteur

Tours Cedex 9
CHRU de Tours - Hôpital Bretonneau

Valenciennes
Hôpital de Valenciennes

Vandoeuvre Les Nancy
C.H.U. Nancy - Brabois

Vannes
CH Bretagne Atlantique - Hôpital Prosper Chubert

Vichy
Centre hospitalier de Vichy


Germany

Aschaffenburg
Gemeinschaftspraxis

Augsburg
Gemeinschaftspraxis

Aurich
Praxis Reichert

Baden-Baden
Medizinische Klinik
Neben

Bayreuth
Klinikum Bayreuth

Berlin
Charité Berlin Campus Virchow-Klinikum

Berlin
Praxis Josting

Bottrop
Onkologische Schwerpunktpraxis Bottrop

Braunschweig
Städtisches Klinikum Braunschweig

Bremen
Klinikum Bremen Mitte

Chemnitz
Klinikum
Hänel

Donauwörth
Onkologisches Zentrum-MVZ Filiale

Dresden
Praxis Freiberg-Richter

Eisenach
Praxis Blumenstengel

Essen
Univ.-Klinikum Essen

Frankfurt
Onkologische Gem. Praxis

Goch
Wilhelm-Anton-Hospital Goch gGmbH

Goslar
Onkologische Kooperation Harz

Gütersloh
Städtisches Klinikum Gütersloh

Halle
Praxis

Hamm
Evangelisches Krankenhaus
Lange

Hannover
Königsmann

Ingolstadt
Praxis

Karlsruhe
Städtisches Klinikum Karlsruhe

Kassel
Gemeinschaftspraxis

Kiel
Universität Kiel - Molekulargenetische Medizinische Klinik

Köln
Gemeinschaftspraxis

Köln
Klinikum der Universität zu Köln

Landshut
Tagesklinik
Vehling-Kaiser

Leipzig
Universität Leipzig

Lübeck
Lübecker Onkologische Schwerpunktpraxis

Magdeburg
Praxis PD

Mainz
Hanusch-Krankenhaus

Mannheim
Universitätsklinikum Mannheim

Marburg
Universitätsklinikum Gießen und Marburg GmbH

Memmingen
Praxis Jäckle

München
Gemeinschaftspraxis

München-Pasing
Praxis Schmidt

Münster
Universitätsklinikum Münster
Schmidt

Nürnberg
Internistische Praxisklinik

Offenburg
Klinikum Offenburg-Ortenau

Osnabrück
Niels-Sensen Kliniken
Wamhoff

Potsdam
Praxis

Rostock
Gemeinschaftspraxis

Rostock
Universitätsmedizin Rostock

Schorndorf
Onkologie Zentrum Bürkle

Schwäbisch-Hall
Diakonie Krankenhaus Schwäbisch-Hall

Stade
MVZ Klinik

Stuttgart
Springer Schwerpunktspraxis Onkologie am Hauptbahnhof

Westerstede
Med. Studiengesellschaft NORD-WEST GmbH

Würzburg
Universitätsklinikum
Goebeler

Greece
Athens
Athens General Hospital Laiko

Athens
General Hospital of Athens "Evangelismos"

Athens
General Hospital of Athens G. Gennimatas

Ioannina
University General Hospital of Ioannina

Patras
University General Hospital of Patras

Thessaloniki
General Hospital of Thessaloniki Papanikolaou


Hungary
Budapest
Egyesitett Szent Istvan-Szent Laszlo Korhaz-Rendelointezet

Debrecen
DEOEC, III Belgyogyaszati Klinika

Gyor
Petz Aladar Megyei Oktato Korhaz

Szedged
Szegedi Tudomanyegyetem


Ireland
Dublin, 8
St James' Hospital


Italy
Alessandria
Az. Osp. SS. Antonio e Biagio e C. Arrigo

Ancona
AOU Osp. Riuniti Umberto I-GM Lancisi-G.Salesi-Univ.Studi

Avellino
Az. Ospedaliera S.G. Moscati

Bari
Az.Osp.Univ.Consorziale Policlin.di Bari Univ.degli Studi

Bergamo
Azienda Ospedaliera Papa Giovanni XXIII

Bologna
Az.Osp.di Bologna Policl.S.Orsola-Malpighi Univ.degli Studi

Bolzano
Az. San. dell'Alto Adige - Comprensorio Sanitario di Bolzano

Brescia
Az. Osp. Spedali Civili di Brescia Univ.degli Studi

Cagliari
Ospedale Oncologico A. Businco
Presidio Ospedaliero Roberto Binaghi - ASL Cagliari

Catania
Presidio Ospedaliero Ferrarotto-AOU Policlinico-V Emanuele
Presidio Ospedaliero Garibaldi - Nesima

Catanzaro
Azienda Ospedaliera Pugliese-Ciaccio

Cona
Az. Osp-Univ. Ferrara - Arcispedale S.Anna Univ. degli Studi

Cremona
Az. Osp. Istituti Ospitalieri di Cremona P.O. di Cremona

Firenze
Az. Osp.Universit.Careggi-Univ. Studi di Firenze

Foggia
A.O.Ospedali-Un.OO.RR Foggia-Pres.Ospedali Riuniti di Foggia

Genova
IRCCS Az. Osp. Univ. S.Martino-IST Ist. Naz. Ric. Cancro

Lecce
Presidio Ospedaliero Vito Fazzi ASL Lecce

Livorno
Presidio Ospedaliero Livorno - ASL Livorno 6

Messina
Az.Ospe.Universitaria Policlinico G. Martino Univ.di Messina

Milano
Az.Ospedaliera Niguarda Ca' Granda
Fond.IRCCS Ca'Granda Ospedale Maggiore Policlinico Univ.Stud
Ospedale San Raffaele IRCCS S.r.l.

Mirano
Presidio Ospedaliero di Mirano - Azienda ULSS 13

Modena
A.O.Univ.Policl.di Modena Univ.Studi Modena e R.Emilia

Monza
Ospedale San Gerardo

Napoli
Azienda Ospedaliera di Rilievo Nazionale A. Cardarelli
A.Osped.-Universit. Policlinico Federico II Univ.degli Studi

Novara
Az. Osp. Univ.Maggiore della Carità

Orbassano
Az.Sanit.Osp.Univers.S.Luigi Gonzaga Orbassano

Padova
Azienda Ospedaliera di Padova Università degli Studi

Pagani
Presidio Ospedaliero Andrea Tortora - ASL Salerno

Palermo
Az.Osp.Univ.Policlinico P.Giaccone Università Studi Palermo
A.O. Ospedali Riuniti Villa Sofia-Cervello - P.O. Cervello
Casa di Cura di Alta Spec. La Maddalena - Dip. Onc III livel

Parma
Az. Ospedaliero Universitaria di Parma

Pavia
Fodazione IRCCS Policlinico S.Matteo Univ.degli Studi Pavia

Perugia
Osp S. Maria della Misericordia-A.O. Perugia - Univ. Studi

Pesaro
Azienda Ospedaliera Ospedale San Salvatore

Pescara
Presidio Ospedaliero Spirito Santo-AUSL Pescara

Piacenza
Presidio Ospedaliero di Piacenza AUSL Piacenza

Pisa
A.O.Univ.Pisana-Pres.Osp.S.Chiara-Univ.degli Studi

Potenza
Azienda Ospedaliera S. Carlo

Reggio Calabria
A.O. Bianchi Melacrino Morelli - Presidio Ospedali Riuniti

Reggio Emilia
Az.Ospedaliera di Reggio Emilia - Arcispedale S. Maria Nuova

Roma
A.O.Policlinico Umberto I - Università La Sapienza
Ospedale S. Eugenio ASL Roma C
Policlinico A. Gemelli-Università Cattolica del Sacro Cuore
Fondaz.Policlin.Tor Vergata-Univ. degli Studi Tor Vergata

Rossano
Presidio Ospedaliero Nicola Giannattasio

Salerno
Az.Osp.Univ.O.O.R.R. S. Giovanni di Dio e Ruggi d'Aragona

San Giovanni Rotondo
IRCCS Casa Sollievo della Sofferenza

Siena
Az.Osp.-Universitaria Senese Università degli Studi di Siena

Taranto
Stab.Osped. S.Giuseppe Moscati- P.O.Centrale SS.Annunziata

Terni
Azienda Ospedaliera S. Maria di Terni - Univ. Studi Perugia

Torino
AO Città della Salute e della Scienza Torino - P.O.Molinette

Treviso
Pres.Ospedaliero S.Maria di Ca' Foncello

Tricase
A.O.Pia Fondaz.di Culto e Religione Card. G. Panico

Udine
Az.Osped.-Universit.Santa Maria della Misericordia di Udine

Venezia
Ospedale dell'Angelo - Az. ULSS n. 12 Veneziana

Verona
.Osp.Univ.Integrata Verona-Osp.Borgo Roma Univ.degli Studi

Vicenza
Presidio Ospedaliero S.Bortolo ULSS 6 Vicenza


Norway
Bergen
Haukeland University Hospital

Oslo
Rikshospitalet


Portugal
Lisboa
Hospital de Santa Maria

Lisboa
Instituto Português de Oncologia de Lisboa

Porto
Instituto Portugues de Oncologia do Porto

Porto
Centro Hospitalar de São João, E.P.E.

Porto
Centro Hospitalar do Porto, EPE - HSA


Slovakia
Bratislava
Fakultna Nemocnica Poliklinikou

Bratislava
Narodny onkologicky ustav - oddelenie klinickej onkologie

Martin
Martinsk.Fakultna Nemocnica


Spain
Alcala de Henares
Hospital Principa de Asturias

Alicante
Hospital General Universitario de Alicante

Alzira
Hospital de la Ribera

Badalona
Hospital Universitario Germans Trias i Pujol

Baracaldo
Hospital de Cruces

Barcelona
Hospital Clinic l Provincial De Barcelona

Barcelona
Hospital de la Santa Creu i Sant Pau

Barcelona
Hospital del Mar

Barcelona
Hospital Vall D'Hebron

Bilbao
Hospital de Basurto

Caceres
San Pedro De Alcantara Hospital

Cordoba
Hospital Reina Sofia

El Palmar
Hospital Universitario Virgen Arrixaca

Gasteiz
Hospital Txagorritxu

Girona
Hospital Universitario de Girona Dr. Josep Trueta

Granada
Hospital Virgen de las Nieves

Hospitalet de LLobregat
Hospital Durans I Reynals-ICO

Jaen
Complejo Hospitalario de Jaen

La Coruna
Complejo Uni. Hosp. A Coruna ( antes Hospital Juan Canalejo)

León
Hospital Virgen Blanca de León

Madrid
Fundacion Jimenez Diaz

Madrid
Hospital Clinico San Carlos

Madrid
Hospital 12 de Octubre

Madrid
Hospital Gregorio Marañon

Madrid
Hospital Infanta Leonor

Madrid
Hospital La Paz

Madrid
Hospital Ramon Y Cajal

Madrid
Hospital Universitario de la Princesa

Majadanonda
Hospital Puerta de Hierro

Málaga
Hospital Carlos Haya

Mallorca
Hospital Son Llatzer

Murcia
Hospital Morales Meseguer

Oviedo
Hospital General de Asturias

Palma de Mallorca
Hospital Son Espases

Pamplona
Complejo Hospitalario de Navarra

Pontevedra
Hospital Provincial de Pontevedra

Sabadell
Corporacio Sanitaria Parc Tauli Sabadell

Salamanca
Hospital Universitario de Salamanca

San Sebastian
Hospital de Donostia

Santa Cruz de Tenerife
Hospital Ntra. Sra. Candelaria

Santander
Hospital Universitario Marques de Valdecilla

Santiago de Compostela
Hospital Clinico Universitario Santiago de Compostela

Sevilla
Hospital Universitario Virgen Marcarena

Sevilla
Hospital Virgen del Rocio

Tarragona
Hospital Universitario Joan XXIII

Valencia
Hospital Universitario i Politecnic La Fe

Valladolid
Hospital Clinico Universitario de Valladolid

Vigo
Hospital Xeral de Vigo

Zaragoza
Hospital Universitario Miguel Servet


Sweden
Göteborg
Sahlgrenska Universitetssjukhuset

Lund
Skånes Universitetssjukhus

Stockholm
Karolinska Universitetssjukhuset Solna

 

UK
London
Hammersmith Hospital London
Barts and the London NHS Trust

Edinburgh
Western General Hospital

Manchester
University Hospital of South Manchester
East Yorkshire
Castle Hill Hospital

Oldham
Royal Oldham Hospital

Salford
Salford Royal Hospital

 

Study title

CML-Paed II = Registration of Children awith CML and Treatment with Imatinib

Scientific title

Protocol for standardized diagnostic procedures, registration, and treatment recommendations in children and adolescents with Philadelphia chromosome-positive chronic myeloid leukemia (CML) (EudraCT 2007-001339-69, ClinicalTrials.gov NCT00445822)

Indication and most important inclusion criteria

Newly diagnosed Ph+ or BCR-ABL-positive CML in children and adolescents under the age of 18 years. Potential study participants have not been pretreated with interferon alpha or any other cytostatic drug with the exception of hydroxyurea or anagrelide (Note: anagrelide is not approved in Germany for the treatment of CML). However, these patients may be registered as observational patients.

Short description of intervention

The objective of this study is to assess the antileukemic activity of imatinib in children and adolescents with newly diagnosed Ph+ or BCR-ABL-CML over a treatment period of two years. Primary endpoint is the rate of haematological, cytogenetical and molecular remissions.

Type of study

Paediatric trial

Current status

No longer recruiting

Study sponsor

Universität Dresden, Germany

Scientific lead / contact

Prof. Dr. Meinolf Suttorp

Principal investigator

Prof. Dr. Meinolf Suttorp
Universitätsklinikum Dresden
Bereich pädiatrische Hämatologie und Onkologie

Study centers / principal investigators

Centers of paediatric haematology oncology within the network of the Society for Paediatric Oncology and Haematology (GPOH) or of the national societies of Paediatric Oncology and Haematology

Additional information

Study description in ClinicalTrials.gov

Study protocol in English, Patient information in Germany, Fachinformation Glivec in German 

 

 

Study title

ENESTop = A clinical research study evaluating the possibility to stop the drug nilotinib in chronic myeloid leukemia (CML) patients who have very small amount of leukemia cells remaining after nilotinib treatment

Scientific title

A phase II, single arm, open label study of treatment-free remission after achieving sustained MR4.5 on nilotinib (EudraCT 2012-003186-18; ClinicalTrials.gov NCT01698905)

Indication and most important inclusion criteria

Chronic myeloid leukemia (CML) chronic phase patients.
Potential participants should have been diagnosed with CML and should have received first-line treatment with imatinib, then switched to nilotinib for at least 2 years prior to study entry with the combined time on imatinib and nilotinib being at least 3 years. Patients must not have documented MR4.5 at the time of switch to nilotinib, and should have achieved MR4.5 on nilotinib.

Short description of intervention

To stop nilotinib treatment in CML-CP patients (who started treatment with ≥ 4 weeks of imatinib, then switched to nilotinib for a minimum of 2 years (with minimum combined duration on imatinib and nilotinib ≥ 3 years), and achieved MR4.5 on nilotinib) who maintained MR4.5 during the 1 year nilotinib treatment on study.

Type of study

Treatment free remission trial

Current status

Recruitment completed

Study sponsor

Novartis Pharma AG

Scientific lead / contact

Yu Jin
Clinical Trial Head

Rafik Fellague-Chebra
Medical Director

Principal investigator

Tim Hughes

Francois-Xavier Mahon

Dong-Wook Kim

Additional information

Study description in the EU Clinical Trials Register which is hosted by the European Medicines Agency (EMA)

Study description in the US register ClinicalTrials.gov, a service of the U.S. National Institutes of Health

"ENESTop brochure: Answers to frequently asked questions patients may have about the study of and treatment with nilotinib"

"ENESTop brochure "Molecular response: a measure of treatment success in Philadelphia chromosome-positive Chronic Myeloid Leukemia (Ph+ CML)"

Study centers

Argentina
Buenos Aires
Fundaleu

Buenos Aires
Hospital Jose Maria Ramos Mejia

Australia
Box Hill
Box Hill Hospital

Adelaide
Royal Adelaide Hospital

St. Leonards
Royal North Shore Hospital

Belgium
Antwerp
ZNA Stuivenberg Hematology/Oncology

Gent
Universitair Ziekenhuis Gent

Haine-saint-Paul
Jolimont

Brazil
Campinas
Universidade de Campinas

Belo Horizonte
Hospital das Clínicas de Belo Horizonte – UFMG

Goiania
Hospital Universitário de Gôiania

Curitiba
Hospital Santa Casa de Curitiba PUCPR

Porto Alegre
Hospital de Clínicas de Porto Alegre

Rio de Janeiro
Instituto Estadual de Hematologia Arthur de Siqueira Cavalca

São Paulo
Hospital das clinicas da Faculdade de Medicina da USP

São Paulo
Irmandade de Santa Casa de Misericordia de Sao Paulo

Rio de Janeiro
Instituo Nacional do Cancer

São Paulo
Casa de Saude Santa Marcelina

Canada
Toronto
Princess Margaret Hospital

Hamilton
The Juravinski Cancer Clinic

Montreal
Hopital Maisonneuve-Rosemont

Québec
Hopital de I'Enfant Jesus

France
Bordeaux
Institut Bergonie

Pierre-Benite Cédex
Centre Hospitalier Lyon-Sud

Vandoeuvre les Nancy
CHU Brabois

Grenoble Cedex 9
Hopital Albert Michallon

Strasbourg Cedex
GH St. Vincent-Clinique Ste Anne

Germany
Berlin
Charité Universitätsmedizin Berlin

Ulm
Universitätsklinikum Ulm

Potsdam
MVZ für Blut- und Krebserkrankungen Potsdam

Mannheim
Universitätsmedizin Mannheim

Heilbronn
Onkologie Heilbronn

Leipzig
Universitätsklinikum Leipzig

Greece
Heraklion Crete
University General Hospital of Heraklion

Athens
Attikon Univ. Gen. Hospital of Athens

Athens, Neo Faliro
Metropolitan Hospital

Athens – GR
General Hospital of Athens Evangelismos

Larissa
University General Hospital of Larissa

Israel
Ramat Gan
The Chaim Sheba Medical Center

Petach Tikva
Rabin Medical Center

Haifa
Rambam Medical Center

Japan
Akita
Akita University Hospital

Fukuoka-city
Kyushu University Hospital

Nagoya
Aichi Cancer Center Hospital

Aomori
Aomori Prefecture Central Hospital

Kurume
Kurume University Hospital

Narita
Narita Red Cross Hospital

Chiba-city
Chiba University Hospital

Korea, Republic of
Seoul
Seoul St. Mary's Hospital

Mexico
San Luis Potosí
Centro Regional de Enfermedades Oncologicas

México
Instituto Nacional de Cancerologia

Monterrey
Hospital y Clinica OCA

Netherlands
Amsterdam
VUMC Amsterdam

Poland
Krakow
Collegium Medicum Uniwersytetu Jagielonskiego (Krakow)

Gdansk
Uniwersyteckie Centrum Kliniczne Katedra i Klinika Hematolog

Warzawa
Instytut Hematologii i Transfuzjologi (Warszawa)

Russian Federation
Moscow
Hematological Scientific Center of RAMS

St. Petersburg
State Pavlov Medical University

St. Petersburg
Research Institute of Hematology and Blood Transfusion, 16

Singapore
Singapore General Hospital

Spain
Madrid
Hospital Universitario de la Princesa

Sevilla
Hospital Virgen del Rocio

Alicante
Hospital General Universitario de Alicante

Badalona
Hospital Universitario Germans Trias i Pujol

Santander
Hospital Universitario Marques de Valdecilla

Madrid
Hospital Ramon y Cajal

Madrid
Hospital Universitario La Paz

Santa Cruz de Tenerife
Hospital Universitario de Canarias

Tunisia
Tunis
Hôpital Aziza Othmana

United Kingdom
Liverpool
Royal Liverpool University Hospital

Nottingham
Nottingham City Hospital

Bournemouth
Royal Bournemouth Hospital

USA
Los Angeles
USC/Kenneth Norris Comprehensive Cancer Center

Indianapolis
Indiana Blood and Marrow Institute

Duarte
City of Hope National Medical Center

Baltimore
St. Agnes Hospital

Vancouver
Compass Oncology

Galveston
University of TX Medical Branch

Study title

BFORE (AV001) = Bosutinib versus Imatinib in Adult Patients with Newly Diagnosed Chronic Phase Chronic Myelogenous Leukemia [Africa, Asia, Australia, Europe, North America]

Scientific title

A Multicenter Phase 3 Randomized, Open-Label Study of Bosutinib versus Imatinib in Adult Patients with Newly Diagnosed Chronic Phase Chronic Myelogenous Leukemia (EudraCT No. 2013-005101-31, clinicaltrials.gov NCT02130557)

Indication and most important inclusion criteria

Patients 18 years and older with molecular diagnosis of chronic phase CML can be enrolled within 6 months from initial diagnosis. Philadelphia chromosome status will be identified at screening. Both Philadelphia positive (Ph+) and Philadelphia negative (Ph-) patients may be included. Patients should have adequate function of liver, kidney and pancreas and an Eastern Cooperative Oncology Group (ECOG) Performance status of 0 or 1. Patients should be able to take oral tablets.

Short description of intervention

The aim of the study is to assess how well bosutinib works compared to imatinib in patients with newly diagnosed Philadelphia chromosome positive (Ph+) chronic phase (CP) chronic myelogenous leukemia (CML). The Major Molecular Response (MMR) rate of bosutinib at 12 months will be compared with that of imatinib. All patients will be treated and/or followed for 5 years (240 weeks) after randomization until the study has closed.

Type of study

First line trials

Current status

no longer recruiting

Study sponsor

Pfizer

Scientific lead / contact

Rocco Crescenzo

Principal investigator

Europe:
Prof. Dr. med. Tim H. Brümmendorf


USA:
Dr. Jorge Eduardo Cortes, M.D.

Additional information

Study description in the EU Clinical Trials Register, which is hosted by the European Medicines Agency (EMA)

Study description in US register ClinicalTrials.gov, a service of the U.S. National Institutes of Health

Study centers / principal investigators

Australia

Adelaide, SA 5000
275 North Terrace
Tim Hughes

Bedford Park SA 5042
SA Pathology (at Flinders Medical Centre)
David Ross (Contact person: Kayleen Charles)

Box Hill, 3128
5 Arnold St
Anthony Schwarer

Frankston, 3199
Frankston Hospital
John Catalano

Kogarah, New South Wales, 2217
St George Hospital
Clinical Trials Unit-Cancer Services, Department of Clinical Haematology,
Dr. Shir-Jing Ho

Belgium

Gent, 9000
University Hospital of Gent (UZ Gent)
Prof. Lucien Noens

Leuven, 3000
UZ Leuven, Hematology Department
Prof. Gregor Verhoef

Liège, 4000
Hematology CHU de Liège - Hôpital du Sart-Tilman
Dr. Marie Lejeune

Verviers, 4800
Centre Hospitalier Peltzer La Tourelle (GHPLT) Verviers
Dr. Gaetan Vanstraelen

Canada

Ontario

Barrie, L4M 6M2
Royal Victoria Regional Health Centre
Dr. Rouslan Kotchetkov

Hamilton, L8V 5C2
Brian Leber

Oshawa, L1G 2B9
Durham Region Cancer Centre Lakeridge Health Oshawa
Dr. Ariah Schattner

Toronto, M5G 2M9
Medical Oncology and Hematology Princess Margaret
Dr. Jeffrey Lipton

New Brunswick

Internal Medicine Department
Moncton Hospital
Moncton, E1C 6Z8
Dr. Nizar Abdel-Samad

Quebec

Montreal, H1T 2M4
Lambert Busque

Quebec City, G1J 1Z4
CHU de Québec - Hôpital de l'Enfant-Jésus
Dr. Robert Delage

Saskatchewan

Saskatoon, S7N 4H4
Dr. Julie Stakiw

 

Czech Republic

Brno, 625 00
Fakultni Nemocnice Brno
Interni Hematoonkologicka a Onkologicka Klinika
Prof. Jiri Mayer

Hradec Kralove, 500 05
Fakultni Nemocnice Hradec Kralove, IV.
Interni Hematologicka Klinika
Dr. Petra Belohlavkova

Olomouc, 77520
Fakultní nemocnice Olomouc
Hematology - Oncology department
Edgar Faber

Prague, 128 08
Ustav Hematologie a Krevni Transfuze
Dr. Hana Klamova

Prague, 128 08
Vseobecna Fakultni Nemocnice Praha, I. Interni Klinika - Klinika Hematologie
Prof. Marek Trneny

 

Denmark

Aalborg, 9000
Aalborg University Hospital
Department of Hematology
Marianne Severinsen

Aarhus, 8000 C
Aarhus University Hospital
Department of Hematology
Prof. Jesper Stentoft

Odense, 5000
Odense University Hospital
Department of Hematology
Hanne Vestergaard

Roskilde, 4000
Roskilde Hospital
Department of Hematology
Dr. Lene Udby

 

Finland

Helsinki, 00029 HUS
M.D. Kimmo Porkka

 

France

Bordeaux, 33076
Service Oncologie Médicale Institut Bergonié- CRLCC
Dr. Gabriel Etienne

Le Chesnay cedex, 78157
Hôpital Mignot
Service Hematologie
Prof. Dr. med. Philippe Rousselot

Nantes cedex 1, 44093
CHU Nantes
Service Hematologie
Dr. med. Viviane Dubruille

Nice, 6202
Hopital l'Archet 1
Dr. Laurence Legros

Nîmes Cedex 9, 30029
Hématologie Clinique
Groupe Hospitalo-Universitaire Caremeau
Dr. Eric Jourdan

Pierre Benite, 69495
CHU Lyon Sud
Hématologie Prof. Dr. med. Mauricette Michallet

Poitiers, 86021
Haematology University Hospital of Poitiers
Cristina Precupanu

Strasbourg, 67000
Haematology St. Anne
M.D. Frederic Maloisel

Toulouse, 31059
Haematology CHU Purpan
Dr. Francoise Huguet (Dr. Travitian)

Germany

Aachen, 52074
Universitätsklinikum Aachen AÖR
Klinik für Onkologie, Hämatologie und Stammzelltransplantation (Med. Klinik IV)
Prof. Dr. med. Tim H. Brümmendorf

Berlin, 13353
Klinik für Innere Medizin mit Schwerpunkt Haematologie
Charité Berlin Campus Virchow Klinikum
Dr. Philipp Le Coutre

Bonn, 53127
Universitaetsklinikum Bonn
Medizinische Klinik 3
Onkologie, Hämatologie und Rheumatologie
Prof. Dr. Dominik Wolf

Dresden, 01307
Universitätsklinikum Carl Gustav Carus
Medizinische Klinik und Poliklinik I
PD Dr. Rainer Ordemann

Essen, 45147
Universitätsklinikum Essen (AOER)
Klinik für Hämatologie
PD Dr. Jürgen Novotny

Freiburg, 79106
Universitätsklinikum Freiburg
Klinik für Innere Medizin I

Hamburg, 20246
Universitätsklinikum Hamburg-Eppendorf
Hämatologie
Dr. Gunhild von Arnsberg

Jena, 07747
Universitätsklinikum Jena
Hämatologie
Prof. Dr. Andreas Hochhaus

Leipzig, 04103
Universitätsklinikum Leipzig AOER
Selbstständige Abt. für Hämatologie
Prof. Dr. Dietger Niederwieser

Magdeburg, 39194
Hämatologie und Onkologie Schwerpunktpraxis
PD Dr. med. Kathleen Jentsch-Ullrich

Mannheim, 68169
Medizinische Fakultät der Universität Mannheim
Dr. Susanne Saußele

 

Hungary

Budapest, 1083
Semmelweis Egyetem I. Belgyógyászat
Prof. Judit Demeter

Debrecen, 4032
Debreceni Egyetem Klinikai Központ, Belgyógyászati Inézet Hematológiai,
Tanszék
Prof. Dr. Árpád Illés

Gyor, 9023
Petz Aladár Megyei Oktató Kórház, II. dept. Internal Medicine-Haematology
Dr. Zoltán Gasztonyi

Kaposvár, 7400
Somogy Megyei Kaposi Mór Oktató Kórház
Hematológiai Osztály
Prof. Miklós Egyed

Szeged, 6723
Szegedi Tudományegyetem, Szent-Györgyi Albert Klinikai Központ, II. sz. Belgyógyászati Klinika és Kardiológiai Központ,
Hematológia
Professor Zita Borbényi

Szolnok, 5004
Jász-Nagykun-Szolnok Megyei Hetényi, Géza Kórház-Rendelőintézet
Dr. Gyorgy Ujj

 

Israel

Haifa, 35953
Hematology and Bone marrow transplant Rambam medical center
Dr. Noam Benyamini

Petah-Tikva, 49100
Rabin Medical Center; Hematology
Prof. Pia Raanani

 

Italy

Bergamo, 24127
A. O. Papa Giovanni XXIII
USC Ematologia
Prof. Alessandro Rambaldi

Bologna, 40138
Policlinico S. Orsola, Ematologia
Prof. Gianantonio Rosti
,

Cagliari, 09121
Oncology Department - Hematology Unit and BMT Centre - Armando Businco Hospital Cagliari
Dr. Emanuele Angelucci

Catania, 95124
Ospedale Ferrarotto - AOU Policlinico - V. Emanuele
Dr. Fabio Stagno

Firenze, 50134
Azienda Ospedaliero Universitaria Careggi - Ematologia
Prof. Alberto Bosi

Genova, 16132
IRCCS AOU San Martino -IST
Prof. Angelo Michele Carella

Milano, 20132
Ospedale San Raffaele,
Unità Operativa di Ematologia e Trapianto Midollo Osseo
Dr. Fabio Ciceri

Monza, 20900
Azienda Ospedaliera S. Gerardo Di Monza
Unità di Ricerca Clinica, Sezione di Ematologia
Prof. Carlo Gambacorti – Passerini

Napoli, 80122
Università Federico II, Div. di Ematologia /
Dip. Di Medicina Clinica e Chirurgica
Prof. Fabrizio Pane

Pescara, 65124
P.O. dello Spirito Santo
Dipartimento di Ematologia U.O. Ematologia
Dr. Paolo Di Bartolomeo

Reggio Calabria, 89124
Haematology Department Azienda Ospedaliera Bianchi Melacrino Morelli
Dr. Bruno Martino

Roma, 00144
Ospedale S. Eugenio, U.O. di Ematologia
Associated Professor Elisabetta Abruzzese

Venezia-Mestre, 30174
U.O. di Ematologia
Ospedale dell'Angelo
Prof. Renato Bassan

 

Mexico

Jalisco, 45170
Hospital General de Occidente
Departamento de Hematología
Dr. Carlos Roberto Best Aguilera

Mexico, D.F., 10700
Hospital Ángeles de Pedregal
Dr. Rafael Hurtado Monroy

Mexico, 11520
Hospital Español
Dr. José Luis Manuel Ayala Sánchez

Monterrey, NL, 6400
Monterrey International Research Center/
Hospital y Clinica Oca.
Dr. Enrique Baez de la Fuente

 

Netherlands

Amsterdam, 1081 HV
VU University Medical Center
Department of Hematology
Associated Professor Jeroen J.W.M. Janssen

Groningen, 9713 GZ
University Medical Center Groningen (UMCG)
Department of Hematology
Prof. Edo Vellenga

 

Norway

Bergen, 5020
Haukeland University Hospital
Depatment of Hematology
Prof. Dr. med. Bjørn Tore Gjertsen

Trondheim, 7006
St. Olavs Hospital
Avd for blodyskdommer
Dr. Henrik Hjorth-Hansen

 

Poland

Chorzów, 41-500
SPZOZ Zespol Szpitali Miejskich, w Chorzowie Oddzial Hematologiczny
Dr. Sebstian Grosicki

Gdansk, 80-952
Uniwersyteckie Centrum Kliniczne
Klinika Hematologii i Transplantologii
Prof. Andrzej Hellmann

Katowice, 40-032
Szpital Kliniczny im. A Mielęckiego, ŚUM w Katowicach, Oddział Hematologii i
Transplantacji Szpiku
Prof. Slawomira Kyrcz-Krzemien

Kraków, 31-501
Dr. Tomasz Sacha

Lodz, 93-510
Wojewódzki Szpital Specjalistyczny im M. Kopernika
Klinika Hematologii Uniwersytetu Medycznego
Prof. Tadeusz Robak

Lublin, 20-081
Katedra i Klinika Hematologii i Transplantacji Szpiku SPSK 1w Lublinie
Dr. Marek Hus

Warszawa, 02-774
Instytut Hematologii i Transfuzjologii, Klinika Hematologii
Prof. Krzysztof Warzocha

Wroclaw, 50-367
Uniwersytet Medyczny im. Piastów Śląskich we Wrocławiu Katedra i Klinika Hematologii
Nowotworów Krwi i Transplantacji Szpiku
Prof. Kazimierz Kuliczkowski

 

Singapore

Singapore, 119228
Dept. of Haematology-Oncology
National University Hospital
Dr. Liang Piu Koh

Singapore, 169856
Singapore General Hospital
Dr. Charles Chuah

Singapore, 308433
Tan Tock Seng Hospital
Dr. Kiat Hoe Ong

 

Slovak Republic

Bratislava, 833 10
Narodny Onkologicky Ustav
Oddelenie Klinickej Hematologie
Dr. Ludmila Demitrovicova

Bratislava, 851 07
University Hospital Bratislava
Clinic of Hematology and Blood Transfusion
Associated Professor Martin Mistrik
(Contact person: Zuzana Sninska)

 

South Africa

Cape Town, 7925
UCT Private Academic Hospital
Division of Haematology
Nicolas Novitsky

Groenkloof, Gauteng, 0075
Mary Potter Oncology Centre
Dr. Graham L Cohen

Parktown, Gauteng, 2193
Wits Clinical Research
Prof. Paul Ruff

Pretoria, Gauteng, 0002
Department of Medical Oncology
Lydia Mary Dreosti

Saxonwold; Gauteng, 2196
Medical Oncology Centre Rosebank
Dr. Bernardo Leon Rapoport

 

South Korea

Anyang, 431-070
Hallym Sacred Heart Hospital
Internal Medicine
Prof. Dae-Young Zang

Busan, 602-715
Sung-Hyun Kim

Daegu, 700-712
Medicine Keimyung University
Dongsan Medical Center
Associated Professor Young-Rok Do

Jeonju, 561-712
Chonbuk National University Hospital
Division of Hematology
Professor Jae-Yong Kwak

Seoul, 110-746
Kangbuk Samsung Hospital
Internal Medicine
Associated Professor Suk-joong Oh

Seoul, 137-701
The Catholic University of Korea
Division of Hematology, Department of Internal Medicine Seoul St. Mary's Hospital
Prof. Dong-Wook Kim

 

Spain

Badalona, 08916
Hospital ICO - Germans Trias i Pujol, Unidad de Investigación Clínica de Hematología
Dr. Cristina Motllo

Barcelona, 08035
Hospital Vall d'Hebron
Haematology Department
Dr. Pere Barba

Barcelona, 08036
Hospital Clinic de Barcelona
Hematology Department
Dr. Francisco Cervantes

Madrid, 28006
Hospital Universitario La Princesa, Hematology and Hemotherapy
Prof. Juan Luis Steegmann

Madrid, 28007
Hospital General Universitario Gregorio Marañón
Haematology Department
Dr. Santiago Osorio Prendes

Madrid, 28034
Hospital Universitario Ramon y Cajal
Oncology
Dr. Valentin Garcia Gutierrez

Madrid, 28040
Hospital Clinico Universitario San Carlos Haematology
Dr. Ascension Pena

Salamanca, 37007
Hospital Universitario de Salamanca, Haematology Department
Dr. Fermin Sanchez-Guijo

Santiago de Compostela, 15706
Hospital Clinico Universitario de Santiago De Compostela
Haematology
Dr. Manuel Mateo Perez Encinas

Toledo, 45004
Hospital Virgen De La Salud
Haematology Department
Dr. Luis Felipe Casado Montero

Valencia, 46010
Hospital Clinico Universitario de Valencia (CHUV)
Hematology and Medical Oncology
Prof. Juan Carlos Hernandez-Boluda

 

Sweden

Linköping, 581 85
Linköping University Hospital
Dept. of Hematology
Dr. Dr. med. Kourosh Lotfi

Lund, 22185
Skåne University Hospital
Dept of Hematology and Vascular Disorders
Prof. Johan Richter

Örebro, 70185
University Hospital Örebro
Div. of Hematology
Mats Bjoereman

Stockholm, 17176
Karolinska University Hospital
Hematology
Associated Professor Leif Stenke

Umeå, 90185
Norrlands University Hospital
Hematological section
Dr. Berit Markevärn

Uppsala, 75185
Uppsala University Hospital
Department of Haematology
M.D. Ulla Olsson Stroemberg

 

Taiwan

Kaohsiung, 80756
Prof. Dr. Ta-Chih Liu
Tainan City, 710
M.D. Yin-Hsun Feng

Taipei, 10449
Mackay Memorial Hospital
Division of Hematology and Oncology, Department of Internal Medicine
Dr. Ken-Hong Lim

Taipei, 11217
Taipei Veterans General Hospital
Division of Hematology- Oncology
Dr. Jin-Hwang Liu

Taichung, 40447
China Medical University Hospital
Hematology and Oncology
Dr. Su-Peng Yeh

Taoyuan County, 33305
Professor Dr. Lee-Yung Shih

 

Thailand

Bangkok, 0000
Ratchathewi, Bangkok
Tontanai Numbenjapon

Bangkok, 10330
King Chulalongkorn Memorial Hospital
Division of Hematology
Department of Medicine
Udomsak U. Bunworasate

Bangkok, 10400
Ramathibodi Hospital
Division of Hematology
Department of Medicine
Ratchathewi
Dr. Pimjai Niparuck

Bangkok, 10700
Siriraj Hospital
Division of Hematology
Department of Medicine
Prof. Dr. Surapol S. Issaragrisil

Chiang Mai, 50200
Adisak A. Tantiworawi

 

Ukraine

Cherkasy, 18009
Municipal Institution "Cherkasy Regional Oncological Dispensary " of Cherkasy Regional Council
Regional Medical and Diagnostic Hematology Center
Dr. Halyna Pylypenko

Ivano-Frankivsk, 76008
Regional Clinical Hospital in Ivano-Frankivsk
Hematology Department
Associated Professor Nataliia Glushko

Khmel'nytsky, 29000
Khmelnytskyi Regional Hospital
Hematology Department
Dr. Grigoriy Rekhtman

Kyiv, 03115
State Institution "National scientific center of clinical radiology NAMS of Ukraine"
Radiation oncohematology and stem cells transplantation department of hematology and transplantology division within Clinical Radiology
Prof. Dr. Iryna Dyagil

Kyiv, 04112
Kyiv City Clinical Hospital #9
Hematology Department #1
Dr. Svitlana Kalinina

Lviv, 79044
State Institution "Institute of Blood Pathology and Transfusion Medicine NAMS of Ukraine"
Hematology Department
Prof. Dr. Zvenyslava Maslyak

 

UK

Birmingham, B9 5SS
Birmingham Heartlands Hospital
Dr. Joanne Ewing

Cardiff, CF14 4XW
Haematology Department
University Hospital of Wales
Dr. Jonathan Kell

Leeds, LS9 7TF
St James Hospital
LCRF (Haematology)
Dr. Graeme Murray Smith
Stewart McConnell
Myeloid Research Nurse

Leicester, LE1 5WW
Leicester Royal Infirmary
HOPE Clinical Trials Unit
Dr. Ann Hunter

Liverpool, L7 8XP
Royal Liverpool University Hospital
Haematology Department
Professor Richard Clark

London, W12 0HS
Haematology Hammersmith Hospital
Catherine Lewis Centre
Dr. Dragana Milojkovic

Nottingham; NG5 1PB
Nottingham University Hospitals NHS Trust – City Campus
Dept. of Clinical Oncology
Dr. Jennifer Byrne

Oxford, OX3 7 LE
Oxford Cancer and Haematology Centre
Churchill Hospital
Dr. Adam Mead

Sheffield, S10 2JF
Royal Hallamshire Hospital
Sameer Tulpule

 

USA

Alabama
Mobile, Alabama 36604
Clinical Trials Department
Thomas W Butler

Arkansas
Hot Springs, Arkansas 71913
Genesis Cancer Center
Dr. R. Timothy Webb

California
Anaheim, California 92801
Pacific Cancer Medical Center Inc.
Ajit S Maniam

Connecticut
Southington, Conneticut 06489
Cancer Center of Central Connecticut
Dr. Peter D. Byeff

Georgia
Atlanta, Georgia 30322
Winship Cancer Institute of Emory University
Hematology and Medical Oncology
Dr. Vamsi K. Kota

Hawaii
Honolulu, Hawaii 96819
Jennifer F. Carney

Illinois
Chicago, Illinois 60612
Hematology & Oncology John H. Stroger, Jr. Hospital of Cook County
Dr. Rosalind Catchatourian
(Contact Person: Dr. Augustin Haidau)

Chicago, Illinois 60612
Rush University Medical Center
Dr. Jamile M. Shammo

Chicago, Illinois 60612
M.D. Irum Khan

Maywood, Illinois 60153
Aileen Go

Indiana
Boise, Indiana 83706
Saint Alphonsus Health System
Dr. Kerry Pulver

Indianapolis, 46237
Indiana Blood & Marrow Transplantation
Dr. Luke Akard

Louisiana
Lafayette, Louisiana 70503
Dr. Salman Malad

Shreveport, Louisiana 71103
Feist-Weiller Cancer Center
LSU Health Sciences Center
Dr. Reinhold Munker

Maryland
Bethesda, Maryland 20817
Center for Cancer and Blood Disorders
Dr. Ralph Boccia

Massachusetts
Worcester, Massachusetts 01655
UMass Memorial Medical Center
Dr. Jan Cerny

Michigan
Ann Arbor, Michigan 48106
St. Joseph's Mercy Hospital
Dr. Christopher Reynolds

Ann Arbor, Michigan 48109
University of Michigan
M.D. Moshe Talpaz

Grosse Pointe Woods, Michigan 48236
St. John Health
Van Elslander Cancer Center
Dr. Carrie L. Dul

Minnesota
Saint Louis Park, Minnesota 55416
Metro MN CCOP
Dr. Daniel Anderson

Mississippi
Tupelo, Mississippi 38801
North Mississippi Hematology and Oncology Assoc., Ltd.
Dr. Andrew Kellum

Missouri
Kansas City, Missouri 64131
Dr. Kelly B Pendergrass

Nebraska
Omaha, Nebraska 68114
Dr. Stefano Tarantolo

New Jersey
Hackensack, New Jersey 07601
Hackensack University Medical Center
John Theurer Cancer Center
Dr. Stefan Faderl

New Mexico
Farmington, New Mexico 87401
San Juan Oncology Associates
Dr. Jeffrey Neidhart

New York
Mineola, New York 11501
Winthrop University Hospital
Michael E. Garrison

New York, New York 10003
Mount Sinai Beth Israel Medical Center
Phillips Ambulatory Care Center
Dr. Ilan Shapira

New York, New York 10021
Memorial Sloan-Kettering Cancer
Dr. Michael J. Mauro

Rochester, New York 14642
University of Rochester Medical Center
James P. Wilmot Cancer Center
Jason H. Mendler

Syracuse, New York 13210
Upstate Medical University
Bernard J. Poiesz

North Carolina
Durham, North Carolina 27710
Dr. David A Rizzieri

Pinehurst, North Carolina 28374
FirstHealth Out Patient Cancer Center
Charles Kuzma

Ohio
Cleveland, Ohio 44106
University Hospitals
Brenda W. Cooper

Cincinnati, Ohio 45267
Stephen Medlin

Pennsylvania
Gettysburg, Pennsylvania 17325
Gettysburg Cancer Center
Dr. Satish Shah

South Carolina
Charleston, South Carolina 29425
Hollings Cancer Center Medical University of South Carolina
Dr. Alice Mims

Greenville, South Carolina 29615
Greenville Health System
M.D. Saeeda Chowdhury

Tennessee
Associates In Oncology and Hematology
Chattanooga, Tennessee 37421
Dr. Jitendra Gandhi

Texas
Houston, Texas 77030
MD Anderson Cancer Center
M.D. Jorge Cortes
(Contact person: Maria "Cookie" Gavino)

Utah
Salt Lake City, Utah 84106
IHO Corp/ Utah Cancer Specialists
Dr. Stephen Kendall

Salt Lake City, Utah 84112
The University of Utah
Huntsman Cancer Institute
Michael W. Deininger

Washington
Seattle, Washington 98101
David Aboulafia

Seattle, Washington 98109
Dr. Vivian Oehler

Wisconsin
Green Bay, Wisconsin 54303
Green Bay Oncology
Dr. Anthony Jaslowski

Milwaukee, Wisconsin 53226
Ehab Atallah

Study title

EUROSKI (EUROStopKinaseInhibitor) = Stopping TKI in patients with CML in complete molecular remission (MR4)

Scientific title

Multicenter prospective trial estimating the persistence of molecular remission in chronic myeloid leukemia after stopping TKI (EUDRACT 2011-000440-22, ClinicalTrials.gov NCT01596114)

Indication and most important inclusion criteria

Chronic myeloid leukemia (CML) in CP on treatment with any TKI in first line or in second line because of toxicity to first line TKI or with TKI in combination

Potential participants of the study should have been treated with TKIs for at least 3 years and should have been in MR4 (less than 0,01% BCR-ABL IS) for at least one year.

At least complete molecular remission MR4 (either (i) detectable disease <=0.01% BCR-ABL IS or (ii) undetectable disease in cDNA with >=10,000 ABL or >=24,000 GUS transcripts) for at least one year; at least three PCR-results with MR4 within the last year (±2 months) before study entry and no PCR-results >0.01% during the same period.
Before inclusion confirmation of MR4 through a EUTOS-CMR laboratory.
Baseline data and documentation on treatment before study entry available.
Known baseline data at diagnosis, EURO-Score

Patients with previous or planned allogeneic stem cell transplantation will be excluded.

Short description of intervention

Stopping TKI in patients with CML in complete molecular remission (MR4)

Type of study

Treatment discontinuation trial

Current status

Recruitment completed

Study sponsor

European LeukemiaNet

Scientific lead / contact

Saussele, Dr. med. Susanne
Universitätsklinikum Mannheim, Germany

Principal investigator

Mahon, Prof. Dr. François-Xavier
CHU de Bordeaux, France

Additional information

Short protocol in European LeukemiaNet
Study description in US register ClinicalTrials.gov, a service of the U.S. National Institutes of Health

Study centers / principal investigators

Czech Republic

Brno
Masaryk University and University Hospital Brno
Dpt. of Internal Medicine, Hematology and Oncology
Prof. Jiri Mayer

Hradec Králové,
University Hospital Hradec Králové
(Fakultni nemocnice HradeKrélové)
4th Department of Internal Medicine - Hematology
Dr. Jaroslava Voglová

Prague
Institute of Hematology and Blood Transfusion, (Ustav hematologie a krevni transfuze)
Prof. Hana Klamova

The Royal Vinohrady Teaching Hospital (Fakultni nemocnice Kralovske Vinohrady)
Dpt. of Internal Medicine and Hematology
Dr. Olga Cerna

Plzen
University Hospital Plzen
Dpt. of Hematology and Oncology
Dr. Michal Karas

Olomouc
University Hospital Olomouc
Dpt. of Hematology and Oncology
Dr. Edgar Faber

Finland

Helsinki
Helsinki University Central Hospital Division of Haematology
Department of Medicine
Prof. Kimmo Porkka

 

France

Angers
CHU d'Angers
Service des Maladies du Sang
Dr. Martine Gardembas-Pain

Bordeaux
Centre Hospitalier Universitaire (CHU) de Bordeaux
Hôpital Haut Lévèque
Pessac
Prof. François-Xavier Mahon

Bordeaux Bergonie
Institut Bergonié
Dr. Gabriel Etienne

Clermont Ferrand
CHU ESTAING
Prof. Marc Berger

Le Chesnay
Hôpital André Mignot,
Service d'Hématologie et d'Oncologie
Prof. Philippe Rousselot

Lille
Universitaire Regional (CHRU) de Lille
Centre Hospitalier
Hôpital Claude Huriez
Dr. Valérie Coiteux

Lyon
Centre Hospitalier Universitaire des Hospices Civils de Lyon (CHU des HCL)
Hôpital Edouard Herriot
Dr. Franck Nicolini

Marseilles
Centre de Lutte Contre le Cancer (CLCC) de Marseille
Institut Paoli-Calmettes (IPC)
Dr. Aude Charbonnier

Nantes
Centre Hospitalier Universitaire (CHU) de Nantes
Hôpital Hôtel-Dieu,
Prof. Viviane Dubruille

Nice
Centre Hospitalier Universitaire (CHU) de Nice
Hôpital de l'Archet
Dr. Laurence Legros

Paris 10
Hôpital Saint-Louis
Dr. Delphine Rea

Paris 15
Hôpital Necker-Enfants Malades
Service Hématologie
Prof. Bruno Varet

Poitiers
Centre Hospitalier Universitaire (CHU) de Poitiers
Hopital de la Milétrie
Prof. François Guilhot

Rennes
Hôpital Pontchaillou
Dr. Martine Escoffre.Barbe

Toulouse
Centre Hospitalier Universitaire (CHU) de Toulouse
Hôpital Purpan
Dr. FrançoiseRigal-Huguet

Tours
CHU de Tours
Dr. Emmanuel Gyan

Vandoeuvre les Nancy
Centre Hospitalier Universitaire (CHU) de Nancy
Hôpital de Brabois
Dr. Agnès-Paule Guerci

 

Germany

Aachen
Universitätsklinikum der RWTH Aachen
Medizinische Klinik IV
Prof. Dr. med. Tim Henrik Brümmendor

Bayreuth
Klinikum Bayreuth GmbH
Medizinische Klinik IV
PD Dr. med. Alexander Kiani

Bonn
Rheinische Friedrich-Wilhelms-Universität Bonn
Medizinische Klinik III
Dr. med. Viktor Janzen

Chemnitz
Klinikum Chemnitz gGmbH
Klinik für Innere Medizin III
Dr. med. Regina Herbst

Dresden
Gemeinschaftspraxis für Hämatologie und Onkologie
PD Dr. med. T. Illmer

Freiburg
Universitätsklinikum Freiburg
Abt. Innere Medizin I
Dr. med. Cornelius Waller

Hamburg
Universitätsklinikum Hamburg-Eppendorf

Heilbronn
Schwerpunktpraxis Onkologie
Dr. med. Jolanta Dengler

Jena
Universitätsklinikum Jena
Klinik und Poliklinik für Innere Medizin II
Hämatologie/Onkologie/Stammzelltransplantation
Prof. Dr. med. Andreas Hochhaus

Kempten
Klinikum Kempten-Oberallgäu gGmbH
Hämatologie, Onkologie und Palliativmedizin
Dr. med. Stefan Hanzel

Leer
Onkologische Schwerpunktpraxis
Dr. med. Carsten Janssen

Mannheim
Universitätsklinikum Mannheim
III. Medizinische Klinik
PD Dr. med. Susanne Saussele

Marburg
Klinikum der Philipps-Universität Marburg
Klinik für Hämatologie/Onkologie/Immunologie
Prof. Dr. med. Andreas Burchert

Munich
Klinikum rechts der Isar der
Technischen Unversität München

Oldenburg
Klinikum Oldenburg
Klinik für Onkologie und Hämatologie
Prof. Dr. med. Doris Kraemer

Straubing
MVZ Klinikum Straubing GmbH
Dr. med. Gernot Freunek

Wendlingen
Onkologische Schwerpunktpraxis
Dr. med. Robert Eckert

Würzburg
Universitätsklinikum Würzburg
Hämatologie/ Onkologie
Dr. Goebeler

 

Greece

Athens
Laikon General Hospital
Propaedeutic University of Athens - School of Medicine
Prof. Panayiotis Panayiotidis

 

Netherlands, The

Amsterdam
VU medisch centrum, secr. Hematologie
Prof. Gert Ossenkoppele

Norway

Oslo
Mr. Tobias Gedde-Dahl

Stavanger
Stavanger University Hospital
Department of Hematology and Oncology,
Dr. Majeed Waleed

Tromsø
University Hospital of Northern Norway
Department of Hematology
Prof. Franz Gruber

Trondheim
Department of Cancer, Research and Molecular Medicine
Prof. Henrik Hjorth-Hansen

 

Portugal

Lisbon
Instituto Portugues de Oncologia Francisco Gentil de Lisboa
Hematology
Dr. Antonio Almeida

 

Sweden

Linköping
Univ hospital Linköping
Haematology Centre
Dr. Kourosh Lotfi

Luleå
Sunderby hospital
Dept of Medicine
Dr. Kristina Myhr-Eriksson

Lund
Skåne University hospital
Haematology Centre
Prof. Johan Richter

Örebro
Univ hospital Örebro
Haematology Centre
Dr. Mats Björeman

Stockholm, Huddinge
Karolinska Univ hospital Huddinge
Haematology Centre
Dr. Sören Lehmann

Stockholm, Karolinska
Karoliniska Univ sjh Solna
Haematology Centre
Dr. Leif Stenke

Sundsvall
Länssj Sundsvall
Dept of Medicine
Dr. Anders Själander

Umeå
Haematology Centre
Norrlands Univ hospital
Dr. Berit Markevärn

Uppsala
Uppsala University hospital
Hematology section
Dr. Ulla Olsson-Strömberg

Study title

TIGER (CML V) = Nilotinib or nilotinib + peginterferon with the aim to discontinue treatment [Europe]

Scientific title

TIGER = Treatment optimization of newly diagnosed Ph/BCR-ABL positive patients with chronic myeloid leukemia (CML) in chronic phase with nilotinib vs. nilotinib plus interferon alpha induction and nilotinib or interferon alpha maintenance therapy (EudraCT 2010-024262-22 clinicaltrials.gov NCT01657604). 

Indication and most important inclusion criteria

Patients with newly diagnosed chronic phase CML and cytogenetic confirmation of Philadelphia chromosome [t(9;22)(q34;q11)]. Patients should be newly treated or non-treated (hydroxyurea for 6 months and imatinib or nilotinib for a duration of up to 6 weeks are permitted).

Short description of intervention

Attempt of CML treatment optimization. There will be two groups in this study: one group will receive nilotinib alone, the other group will receive a combination of nilotinib and interferon alpha. During a later treatment phase, nilotinib or interferon alpha will be given as maintenance therapy, and discontinued if MR improves further for at least 12 months.

Type of study

First-line trial

Current status

No longer recruiting

Study sponsor

Friedrich-Schiller-Universität Jena
Germany

Scientific lead / contact

Hochhaus, Prof. Dr. med. Andreas
Universitätsklinikum Jena

Principal investigator

Prof. Dr. med. Andreas Hochhaus
Universitätsklinikum Jena
Abteilung Hämatologie und Internistische Onkologie

Additional information

• Study description in the EU Clinical Trials Register which is hosted by the European Medicines Agency (EMA)
• Study description in the US register ClinicalTrials.gov, a service of the U. S. National Institutes of Health
• Short protocol in Kompetenznetz Leukämien
• German patient information sheet

Study centers

Czech Republic

Brno
University Hospital and Masaryk University Brno
Daniela Zackova, MD

 

Germany

 

Aachen
Universitätsklinikum Aachen
Medizinische Klinik IV
Steffen Koschmieder, Prof. MD

 

 

Amberg
Gesundheitszentrum St. Marien GmbH
Onkologie/ Hämatologie Onkologisches Zentrum
Ludwig Fischer von Weikersthal, MD

Arnsberg
MVZ am Klinikum Arnsberg GmbH
Hämatologie - Internistische Onkologie
Karsten Schulmann, MD

 

Aschaffenburg
Studienzentrum Drs. Klausmann/Dr. Welslaus
Martine Klausmann, MD

 

Bad Saarow
Helios Klinikum Bad Saarow
Klinik für Hämatologie, Onkologie und Palliativmedizin
Peter Reichardt, PD MD

 

Bayreuth
Klinikum Bayreuth GmbH
Alexander Kiani, PD MD

 

Berlin
Charité - Campus Benjamin Franklin
Medizinische Klinik III
Igor Wolfgang Blau, PD MD

 

Berlin
Charité CVK, CC14,
Klinik für Hämatologie und Onkologie
Philipp le Coutre, MD    

 

Berlin
Vivantes Netzwerk für Gesundheit GmbH
Klinikum Neukölln
Klinik für Innere Medizin - Hämatologie und Onkologie
Maike de Wit, Prof. MD  

 

Bonn
Universitätsklinikum Bonn
Med. Klinik und Poliklinik III, Hämatologie
Viktor Janzen, MD

 

Bonn
Evangelische Kliniken Bonn gGmbH
Johanniterkrankenhaus
Yon Dschun Ko, Prof. MD

 

Braunschweig
Städtisches Klinikum Braunschweig gGmbh
Medizinische Klinik III – Hämatologie
Ulrike Helbig, MD

 

Bremen
DIAKO Ev. Diakonie-Krankenhaus gGmbH
Medizinische Klinik II
Johannes Kullmer, MD

 

Bremen
Klinikum Bremen-Mitte gGmbH
Bernd Hertenstein, Prof. MD

 

Chemnitz
Klinikum Chemnitz gGmbH
Klinik für Innere Medizin III, PD MD

 

Coburg
Praxis Dr. med. Zöller
Thomas Zöller, MD

 

Cottbus
Onkologische Schwerpunktpraxis
Ulrich von Grünhagen, MD

 

Dresden
Onkologische Schwerpunktpraxis
Thomas Illmer, PD MD

 

Dresden
Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden
Rainer Ordemann, PD MD

 

Dresden
Gemeinschaftspraxis Mohm / Prange-Krex
Johannes Mohm, MD

 

Düsseldorf
Marien Hospital Düsseldorf
Klinik für Onkologie, Hämatologie und Palliativmedizin
Aristoteles Giagounidis, PD MD

 

Eisenach
Onkologisch-Hämatologische Schwerpunktpraxis
Klaus Blumenstengel, MD

 

Erlangen
Universitätsklinikum Erlangen
Medizinische Klinik 5 - Hämatologie und int. Onkologie
Babette Häcker, MD

 

Erlangen
Onkologische Schwerpunktpraxis Erlangen
Onkologie, Hämatologie
Stefan Krause, Prof. MD

 

Eschweiler
St.-Antonius-Hospital
Klinik für Hämatologie Onkologie
Frank Schlegel, MD

 

Essen
Universitätsklinikum Essen
Klinik für Hämatologie
Jürgen Novotny, PD MD

 

Freiburg
Universitätsklinikum Freiburg
Abteilung Innere Medizin I - Hämatologie und Onkologie
Cornelius Waller, Prof. MD

 

Fulda
MVZ-Osthessen GmbH
Klinikum Fulda Tumorklinik
Heinz-Gert Höffkes, Prof. MD

 

Gerlingen
Praxis Dr. med. Schmitt
Hans R. Schmitt, PD MD

 

Goch
Wilhelm-Anton-Hospital gGmbH
Klinik für Innere Medizin, Hämatologie und Internistische Onkologie
Volker Runde, Prof. MD

 

Goslar
Dr. med. Hans Werner Tessen
Facharzt für Innere Medizin
Hans Werner Tessen, MD

 

Göttingen
Georg-August Universität Göttingen
Abteilung Hämatologie und Onkologie
Florian Zettl, MD

 

Greifswald
Universitätsmedizin Greifswald
Klinik und Poliklinik für Innere
Christian-Andreas Schmidt, Prof. MD

 

Güstrow
Internistische Gemeinschaftspraxis
Stefan Wilhelm, MD

 

Hagen
Katholisches Krankenhaus Hagen gem. GmbH
Klinik für Hämatologie und Onkologie
Hans-Walter Lindemann. MD

 

Halle
Hämatologisch-onkologische Gemeinschaftspraxis
Claudia Spohn, MD

 

Hamburg
Asklepios Klinik St. Georg, Abteilung Hämatologie, Onkologie, Stammzelltransplantation
Norbert Schmitz, Prof. MD

 

Hamburg
Hämatologisch-Onkologische Praxis Altona
Struensee-Haus
Erik Engel, MD

 

Hamburg
MVZ Hämatologie-Onkologie
Svenja Neumann, MD

 

Hamburg
Universitätsklinikum Hamburg- Eppendorf
Medizinische Klinik 2
Philippe Schafhausen, MD

 

Hamm
St. Marien-Hospital Hamm
Klinik für Hämatologie und Onkologie
Heinz Dürk, MD

 

Hamm
Evangelisches Krankenhaus Hamm
Elisabeth Lange, MD

 

Hannover
Medizinische Hochschule Hannover
Klinik für Hämatologie, Hämostaseologie, Onkologie und Stammzelltransplantation
Matthias Eder, Prof. MD

 

Hannover
Mediprojekt
Gesellschaft für Medizinstatistik und Projektentwicklung
Michael P. Koenigsmann, Prof. MD

 

Heidelberg
Universitätsklinikum Heidelberg
Innere Medizin V: Hämatologie, Onkologie und Rheumatologie
Eike C. Buss, MD

 

Heilbronn
Internistische Gemeinschaftspraxis Heilbronn
Jolanta Dengler, MD

 

Hildesheim
St. Bernward Krankenhaus Hildesheim
Ulrich Kaiser, Prof. MD

 

Homburg/Saar
Universitätsklinikum des Saarlandes Klinik für Innere Medizin I
Michael Pfreundschuh, Prof. MD

 

Idar-Oberstein
Klinikum Idar-Oberstein GmbH
Innere Medizin I (Hämatologie/Onkologie)
Eva Roemer, MD

 

Ingolstadt
MVZ Onkologie Ingolstadt
Ole Maywald, MD

 

Jena
Universitätsklinikum Jena
Klinik für Innere Medizin II
Abt. Hämatologie und internistische Onkologie
Andreas Hochhaus, Prof. MD

 

Jena
Eps- early phase solutions GmbH
Klaus Ruffert, PD MD

 

Kaiserslautern
Westpfalz-Klinikum GmbH
Innere 1
Stefan Mahlmann, MD

 

Karlsruhe
St. Vincentius-Kliniken Karlsruhe
Michael Schatz, MD

 

Karlsruhe
Städtisches Klinikum Karlsruhe gGmbH
Medizinische Klinik III: Hämatologie/Onkologie
Martin Bentz, Prof. MD

 

Kiel
Universitätsklinikum Schleswig-Holstein
II. Medizinische Klinik und Poliklinik im Städtischen Krankenhaus Kiel
Björn-Niklas Heydrich, MD

 

Koblenz
InVO, Institut für Versorgungsforschung in der Onkologie
Jörg Thomalla, MD

 

Krefeld
Onkologische Gemeinschaftspraxis Dr. M. Neise u. Dr. A. Lollert
Michael Neise, MD

 

Kronach
Onkologische Schwerpunktpraxis
Martina Stauch, MD

 

Kronach
Onkologische Schwerpunktpraxis
Peter Anhut, MD

 

Landshut
Hämatologisch-Onkologische Tagesklinik'
Ursula Vehling-Kaiser, MD

 

Lebach
Onkologisches Zentrum Gemeinschaftspraxis für Hämato-/ Onkologie
Abt. für Hämato-/ Onkologie im Caritas Krankenhaus
Stephan Kremers, MD

 

Leer
Onkologisches Schwerpunktpraxis
Lothar Müller, MD

 

Leipzig
Universitätsklinikum Leipzig
Department für Innere Medizin
Dietger Niederwieser, Prof. MD

 

Leipzig
Dr. Aldaoud - Dr. Schwarzer Forschungsgesellschaft mbH
Andreas Schwarzer, MD

 

Limburg/Lahn
Krankenhausgesellschaft St. Vincenz mbH Limburg
Thomas Neuhaus, PD MD

 

Magdeburg
Gemeinschaftspraxis Uhle, Müller, Kröning, Jentsch-Ullrich
Kathleen Jentsch-Ullrich, PD MD

 

Mainz
Universitätsmedizin der Johannes- Gutenberg Universität
III. Medizinische Klinik und Poliklinik, Hämatologie, internistische Onkologie und Pneumologie
Thomas Kindler, MD

 

Mainz
Internistische Gemeinschaftspraxis Onkologie/Hämatologie
Ute Kreiter, MD

 

Mannheim
Mannheimer Onkologie Praxis
Christoph Plöger, MD

 

Mannheim
Universitätsmedizin Mannheim
III. Medizinische Klinik
Susanne Saußele, MD

 

Marburg
Klinikum der Philipps-Universität Marburg
Klinik für Innere Medizin
Schwerpunkt Hämatologie, Onkologie und Immunologie
Andreas Burchert, Prof. MD

 

Minden
Johannes Wesling Klinikum Minden
Mühlenkreikliniken (AöR)
Hämatologie/Onkologie
Hans J. Tischler, MD

 

Mutlangen
Stauferklinikum Schwäbisch Gmünd, Zentrum Innere Medizin
Holger F. Hebart, Prof. MD

 

München
Gemeinschaftspraxis Hämatologie/ Onkologie
Burkhard Schmidt, MD

 

München
Klinikum rechts der Isar
III. Medizinische Klinik und Poliklinik
Philip Jost, MD

 

München
MHP Münchener Hämatologie Praxis
Torsten Haferlach, Prof. MD

 

München
Hämatologisch-Onkologische Schwerpunktpraxis
Helmut Hitz, MD

 

München
Tumorzentrum München Süd
Klinikum Harlaching
Thomas Will, MD

 

München
Hämatologisch-Onkologische Gemeinschaftspraxis
Oliver Stoetzer, MD

 

München
Universitätsklinikum Grosshadern
LMU München
Werner Olipitz, MD

 

Neumarkt
Onkologische und hämatologische Schwerpunktpraxis
Ekkehart Ladda, MD

 

Nürnberg
Ambulantes BehandlungsCentrum des Klinikums Nürnberg
Hämatologie/Onkologie, Nuklearmedizin
Christiane Falge, MD

 

Oldenburg
Klinikum Oldenburg
Klinik für Onkologie und Hämatologie / Innere Medizin II
Doris Kraemer, Prof. MD

 

Paderborn
Brüderkrankenhaus St. Josef Paderborn
Tobias Gaska, Prof. MD

 

Passau
Klinikum Passau
II. Medizinische Klinik
Thomas Südhoff, Prof. MD

 

Recklinghausen
Klinikum Vest
Behandlungszentrum Recklinghausen
Medizinische Klinik III
Otto Kloke, Prof. MD

 

Regensburg
Universitätsklinikum Regensburg
Abteilung für Hämatologie und internistische Onkologie
Matthias-Georg Edinger, Prof. MD

 

Regensburg
Krankenhaus Barmherzige Brüder Regensburg
Klinik für Onkologie und Hämatologie
Michael Schenk, MD

 

Reutlingen
Kreiskliniken Reutlingen GmbH
Klinikum am Steinenberg
Medizinische Klinik I
Alexander Wacker, MD

 

Rostock
Universitätsmedizin Rostock
ZIM II Klinik für Hämatologie und Onkologie
Christian Junghanß, Prof. MD

 

Schweinfurt
Leopoldina-Krankenhaus
Hans Reinel, MD

 

Schwäbisch Hall
Diakonie-Klinikum Schwäbisch Hall gGmbH
Innere Medizin III: Sektion für Onkologie und Hämatologie
Daniel Debatin, MD

 

Sindelfingen
Klinikverbund Südwest
Kliniken Sindelfingen-Böblingen gGmbH
Markus Ritter, PD MD

 

Stuttgart
Diakonie Klinikum Stuttgart
Medizinische Klinik
Else Heidemann, Prof. MD

 

Trier
Klinikum Mutterhaus der Borromäerinnen
Rolf Mahlberg, MD

Trier
Internistische Gemeinschaftspraxis
Bernhard Rendenbach, MD      

 

Tübingen
Medizinische Universitätsklinik
Department für Innere Medizin
GCP Studienzentrale der Abteilung 2
Robert Möhle, Prof. MD

 

Ulm
Universitätsklinikum Ulm
Klinik für Innere Medizin III
Frank Stegelmann, MD

 

Villingen-Schwenningen
Schwarzwald-Baar Klinikum Villingen-Schwenningen GmbH
Wolfram Brugger, Prof. MD

 

Waiblingen
Rems-Murr-Klinik Waiblingen
Stefani Parmentier, MD

 

Weiden
Medizinisches Versorgungszentrum GmbH
Robert Funck  

 

Wendlingen
Dres. med. T. Kamp - R. Eckert
Innere/Hämatologie/Onkologie
Torsten Kamp, MD

 

Würselen
Onkologische Gemeinschaftspraxis Würselen und Stolberg
Christoph Maintz, MD

 

Würzburg
Universitätsklinikum Würzburg
Medizinische Klinik und Poliklinik II
Volker Kunzmann, PD MD

 

Switzerland

 

Aarau
Kantonspital Aarau AG
Nathan Cantoni, MD

 

Bern
Inselspital Bern
Gabriela Baerlocher, Prof. MD

 

Basle
Universitätsspital Basel
Dominik Heim, MD

 

Geneva
Hopitaux Universitaires de Genève
Yves Chalandon, Prof.  MD

 

Lausanne
Hopitaux Universitaires de Genève
Olivier Spertini, Prof. MD

 

Liestal
Kantonsspital Baselland
Genviève Favre, MD

 

Luzern
Luzerner Kantonsspital
Michael Gregor, MD