DACOTA = Decitabine with or without Hydroxyurea versus Hydroxyurea in CMML[Europe]

Study title

DACOTA = Phase III Trial of Decitabine with or without Hydroxyurea versus Hydroxyurea in CMML [Europe]

Scientific title

Randomized Phase III Study of Decitabine +/- Hydroxyurea (HY) Versus HY in Advanced Proliferative CMML (GFM-DAC-CMML) (EudraCT no. 2014-000200-10, ClinicalTrials.gov NCT02214407)

Indication and most important inclusion criteria

This study enrolls patients aged 18 years and older with a CMML diagnosis according to WHO criteria and a white blood count of at least 13 G/L. Patients must also meet at least two further criteria, such as bone marrow blasts at least 5%, anemia or enlarged spleen. Patients must not have received any other treatment except for best best supportive care (BSC), erythropoiesis stimulating agents (ESAs) and short-term treatment with hydroxyurea.

Short description of intervention

Patients with advanced Chronic Myelomonocytic Leukemia (CMML) will be assigned to one of two study arms and will receive one of the following two treatments: either 20 mg/m2 decitabine intravenously for 5 days every 28 days with our without hydroxyurea or hydroxyurea alone at a dose of up to 4 g/day.
Treatment will be continued until an event is reached (death, transformation to acute myeloid leukemia (AML) or progression of meloproliferation (increase in myelocyte count))

Type of study

Other haematological trials (non-CML)

Current status

No longer recruiting

Study sponsor

Groupe Francophone des Myelodysplasies (GFM), Paris

Scientific lead / contact

Pierre Fenaux

Principal investigator

Pierre Fenaux, Hopital St Louis T4, Paris

Additional information

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

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

Study centers / principal investigators

France

Angers
CH Angers
Angers, 49 000

Bayonne
Centre Hospitalier de La Cote Basque
Bayonne, 64100

Bobigny
Hôpital Avicenne
Bobigny, 93009

Bordeaux Pessac
CHU de Haut-Lévèque
Bordeaux Pessac, 33604

Clermont-Ferrand
CHU de Clermont-Ferrand
Clermont-Ferrand, 63058

Creteil
Centre Henri Mondor
Creteil, 94010

Grenoble
Service d'Hématologie Clinique
CHU Albert Michallon,
Grenoble, 38043

Limoges
CHRU de Limoges
Limoges, 87046

Lyon
Centre Hospitalier Lyon Sud
Lyon, 69495

Marseille
Département d'hématologie
Institut Paoli-Calmette, Marseille, 13009

Nice
Hematology Dpt, CHU Archet
Nice, 06202

Paris
Hopital St Louis T4
Paris, 75475

Perpignan
Centre Hospitalier Joffre
Perpignan, 66046

Rouen
Centre Henri Bequerel
Rouen, 76038

Toulouse
Hopital Purpan Service d'Hématologie Clinique
Toulouse


Germany

Berlin
Charité-Universitätsmedizin Berlin
Campus Benjamin Franklin
Medizinische Klinik III / Hämatologie, Onkologie und Transfusionsmedizin

Chemnitz
Klinikum Chemnitz gGmbH
Klinik für Innere Medizin III

Dresden
Universitätsklinikum Carl Gustav Carus an der TU Dresden
Medizinische Klinik I

Düsseldorf
Marien Hospital Düsseldorf GmbH
Akademisches Lehrkrankenhaus der Universität Düsseldorf
Innere Medizin und Hämatologie

Düsseldorf
Klinik für Hämatologie, Onkologie und klinische Immunologie
Heinrich Heine Universität Düsseldorf

Freiburg
Universitätsklinikum Freiburg
Klinik für Innere Medizin I
Hämatologie, Onkologie und Stammzelltransplantation

Hamburg
Asklepios Klinik St. Georg
Abteilung Hämatologie, Onkologie und Stammzelltransplantation

Hannover
Klinik für Hämatologie, Hämostaseologie, Onkologie und Stammzelltransplantation
Medizinische Hochschule Hannover

Mannheim
Universitätsklinikum Mannheim Medizinische
Klinik III Hämatologie und Internistische Onkologie

München
Technische Universität München
Klinikum Rechts der Isar
III. Medizinische Klinik

Potsdam
Medizinisches Versorgungszentrum für Blut- und Krebserkrankungen

Tübingen
Universität Tübingen
Medizinische Klinik Hämatologie/Onkologie/Pulmologie

Winnenden
Onkologie und Palliativmedizin
Rems-Murr-Klinik Waiblingen

 

 

 

DasaHIT = Dasatinib Holiday for Improved Tolerability [Germany]

Study title

DasaHIT = Dasatinib Holiday for Improved Tolerability

Scientific title

Treatment optimization for patients with chronic myeloid leukemia (CML) with treatment naive disease (1st line) and patients with resistance or intolerance against alternative Abl-Kinase Inhibitors (2nd line) (EudraCT 2015-003502-16)

Indication and most important inclusion criteria

This study includes patients aged 18 years and above who have been newly diagnosed with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemie (CML) in any phase or who have failed treatment or are intolerant to previous treatment with other tyrosine kinase inhibitors (TKI) (imatinib, nilotinib, bosutinib, ponatinib). To be included patients must also have a score of at least 2 on the ECOG performance scale assessing the quality of life of cancer patients.

Patients with Ph-negative CML or socalled variant translocations, who are BCR-ABL-positive, are also considered eligible for inclusion.

Short description of intervention

This study will investigate whether treatment with dasatinib over two years is equally effective when dasatinib is not given on weekends (treatment pause) compared to daily administration of dasatinib without treatment pauses.

Type of study

First-line trial, trial after therapy failure or intolerance, therapy optimization trial

Current status

No longer recruiting

Study sponsor

Friedrich-Schiller-Universität Jena, Germany, with financial support from Bristol-Myers Squibb

Scientific lead / contact

Prof. A. Hochhaus
Klinik und Poliklinik für Innere Medizin II
Universitätsklinikum Jena
Germany

Principal investigator

Prof. A. Hochhaus
Klinik und Poliklinik für Innere Medizin II
Universitätsklinikum Jena
Germany

Additional information

Short protocol

Study centers / principal investigators

Germany

Uniklinik der RWTH Aachen
Klinik für Hämatologie, Onkologie, Hämostaseologie und Stammzelltransplantation
Aachen

Gesundheitszentrum St. Marien GmbH
Amberg

Gemeinschaftspraxis
Dr. med. Hans R. Slawik
Martin Deuringer
Dr. med. Margarete Plath
Augsburg

Studienzentrum Aschaffenburg
Aschaffenburg

Internistische FA-Praxis Prof. Josting
Berlin

Evangelisches Klinikum Bethel gGmbH
Klinik für Innere Medizin, Hämatologie|Onkologie und Palliativmedizin
Bielefeld

Universitätsklinikum Bonn
Bonn

Klinikum Bremen Mitte gGmbH
Bremen

Klinikum Chemnitz
Chemnitz

Gemeinschaftspraxis Mohm
Dresden

Universitätsklinikum Carl Gustav Carus
Dresden

HELIOS St. Johannes Klinik Duisburg
Duisburg

Gemeinschaftspraxis
Dr. M. Eckart und Dr. B. Häcker
Erlangen

Universitätsklinikum Essen
Essen

Universitätsklinikum
Freiburg

Klinikum Goch
Goch

MVZ Onkologische Kooperation Harz
Hämatologie und Internistische Onkologie
Dr. med Mark-Oliver Zahn
Goslar

ConMed GmbH
Göttingen

Hämato-Onkologische Gemeinschaftspraxis Halberstadt
Halberstadt

Universitätsklinikum
Halle/S.

MediProjekt GbR Hannover
Hannover

St. Bernward Krankenhaus Hildesheim
Medizinische Klinik II / MVZ Onkologie
Hildesheim

Universitätsklinikum Jena
Jena

IDGGQ
Kaiserslautern

Onkolog. Schwerpunktpraxis, Dres. Richard Hansen, Susanne Pfitzner-Dempfle, Manfred Reeb
Kaiserslautern

Städt. Klinikum Karlsruhe
Karlsruhe

St. Vincentius-Kliniken Karlsruhe
Medizinische Klinik 2
Hämatologie, Onkologie, Immunologie, Palliativmedizin
Karlsruhe

Klinikum Kassel
Hämatologie/Onkologie/Immunologie
Kassel

Onkologische Gemeinschaftspraxis
Dr. med. Siegfried Siehl
Dr. med. Ulrike Söling
Kassel

Städtisches Krankenhaus Kiel
Kiel

Universitätsklinikum SH
Kiel

Institut für Versorgungsforschung in der Onkologie GbR
Koblenz

Gemeinschaftspraxis für Hämatologie und Onkologie
Prof. Dr. med. Stephan Schmitz
Dr. med. Tilmann Steinmetz
Dr. med. Kai Severin
Köln

MVZ Hämatologie und Onkologie
Krefeld

Onkologisches Zentrum
Gemeinschaftspraxis für Hämatologie und Onkologie
Im Caritas Krankenhaus
Lebach
2nd site: Saarlouis

Studienzentrum UnterEms
MVM mbH
Leer
2nd site: Onkologie UnterEms
Emden

Universität Leipzig
Leipzig

Gemeinschaftspraxis
Dres. Müller, Kröning, Jentsch-Ullrich, Tietze und Krogel
Magdeburg

Universitätsmedizin Mannheim
Mannheim

Universitätsklinikum Gießen und Marburg GmbH
Standort Marburg

Rotkreuzklinikum
München

Schick Hämatologisch-Onkologische Praxisgemeinschaft
München

Medizinische Klinik A (Hämatologie, Hämostaseologie, Onkologie und Pneumologie)
Münster

Stauferklinikum Schwäbisch Gmünd
Mutlangen

Hämatologisch-onkologische Schwerpunktpraxis
Neustadt a. Rbge

Klinikum Passau
Passau

Kreisklinikum Reutlingen
Reutlingen

Klinikum Südstadt Rostock
Rostock

Hämatologie-Onkologie Stolberg
Stolberg

Universitätsklinikum Ulm
Ulm

Klinikum der Stadt Villingen-Schwenningen
Villingen-Schwenningen

Rems-Murr-Klinik Winnenden
Onkologie und Palliativmedizin
Winnenden


PONDEROSA [Czechia, Germany]

Study title

PONDEROSA = Observational study with ponatinib

Scientific title

Observational study on CML patients in any phase treated with ponatinib (Iclusig®) at any dose

Indication and most important inclusion criteria

The study includes patients aged 18 years and older with chronic myeloid leukemia (CML) in any phase on treatment with ponatinib at any dose. Eligible for inclusion are patients who fulfill all inclusion criteria and have given their written consent to participate in the observational study.

Short description of intervention

Further data is needed to characterize the safety profile of ponatinib in routine clinical use in Europe. This observational study will render a realistic picture of the routine clinical use of ponatinib. It will also provide further information on the number and type of adverse events including their outcome in CML patients in any phase treated with ponatinib.

Type of study

Other trial

Current status

No longer recruiting

Study sponsor

Friedrich-Schiller-Universität Jena, Germany, with financial support from Incyte Inc.

Scientific lead / contact

Prof. A. Hochhaus
Klinik und Poliklinik für Innere Medizin II
Universitätsklinikum Jena
07747 Jena
Germany

Principal investigator

Prof. A. Hochhaus
Klinik und Poliklinik für Innere Medizin II
Universitätsklinikum Jena
07747 Jena
Germany

Additional information

Study summary by Universitätsklinikum Jena in German

Study centers / principal investigators

Czechia

University Hospital Brno
Brno

University Hospital Hradec Králové
Hradec Králové

University Hospital Olomouc
Olomouc

University Hospital Plzen
Plzen

Institute of Hematology and Blood Transfusion Praha
Praha

University Hospital Vinohrady
Praha

 

Germany

Uniklinik der RWTH Aachen
Aachen

Studienzentrum Aschaffenburg
Aschaffenburg

Klinikum Augsburg
Augsburg

Charité - Universitätsmedizin Berlin, Campus Virchow - Klinikum
Berlin

Internistische FA-Praxis Prof. Josting
Berlin

Praxis Dr. Heßling
Berlin

Onkologische Praxis An der Wertach
Bobingen

St. Vincenz-Krankenhaus
Datteln

Gemeinschaftspraxis Mohm / Prange-Krex
Dresden

Universitätsklinikum Essen
Essen

Onkologische Schwerpunktpraxis
Esslingen

Centrum für Hämatologie und Onkologie Bethanien
Frankfurt/M

Klinikum Goch
Goch

MVZ Onkologische Kooperation Harz
Goslar

Universitätsklinikum Greifswald
Greifswald

OncoResearch Lerchenfeld GmbH
Hamburg

Universitätsklinikum Halle
Halle

OncoCare GbR Halver
Halver

St. Ansgar Krankenhaus Höxter
Höxter

Universitätsklinikum Jena
Jena

Praxis Dr. Steinmetz
Köln

Universitätsklinikum Leipzig
Leipzig

Gemeinschaftspraxis Dres. Müller, Kröning, Jentsch-Ullrich und Tietze
Magdeburg

Universitätsmedizin Mannheim
Mannheim

Rotkreuzklinikum München
München

Schick Hämatologisch-Onkologische Praxisgemeinschaft
München

Hämatologisch-onkologische Schwerpunktpraxis
Neustadt a. Rbge.

Klinikum Passau
II. Medizinische Klinik
Passau

Onkologische SPP Porta Westfalica
Porta Westfalica

Onkologiezentrum Soest
MVZ Kloster Paradiese
Soest

Onkologische Praxis und Tagesklinik Stuttgart
Stuttgart

Klinikum Traunstein
Traunstein

Universitätsklinikum Ulm
Ulm

Klinikum der Stadt Villingen-Schwenningen
Villingen-Schwenningen

Gemeinschaftspraxis für Hämatologie und Onkologie Dr. med. Reichert
Westerstede

MVZ des Marien-Hospital Witten
Witten

Gemeinschaftspraxis Dres. Bock
Wittenberge

Cancer Center Zweiseenland GbR Wolfratshausen
Wolfratshausen

Schwerpunktpraxis Würzburg
Würzburg

MVZ Polikinik West Zwickau
Zwickau

 

ASCEMBL (CABL001A2301) = ABL001 versus bosutinib in CML-CP patients pretreated with ≥2 TKI [Asia, Australia, Europe, North America, Central America, South America]

Study title

Read more ...

BEST - Bosutinib in Elderly Chronic Myeloid Leukemia [Italy]

Study title

Bosutinib in Elderly Chronic Myeloid Leukemia (BEST)

Scientific title

Bosutinib Efficacy, Safety, Tolerability (BEST) Study in Elderly Chronic Myeloid Leukemia Patients Failing Front-line Treatment With Other Tyrosine Kinase Inhibitors (ClinicalTrials.gov NCT02810990)

Indication and most important inclusion criteria

Male or female patients 60 years of age or older with a molecular confirmed diagnosis of BCR-ABL1+ CML in chronic phase and prior first-line treatment with any other tyrosine kinase inhibitor.
Patients can be considered for inclusion in the study if they are intolerant to prior treatment, based on investigator and patient assessment, or have not responded to prior treatment (assessed according to any one of the ELN 2013 criteria).

Short description of intervention

The purpose of this study is to evaluate the tyrosine kinase inhibitor (TKI) bosutinib in elderly patients who did not obtain any benefit with other drugs before.

The median age of newly diagnosed CML patients is about 56 years, and at least 40% of all newly diagnosed patients are over 60 years old. Particularly for these elderly patients, the choice of TKI must take into account the safety and tolerability profile of the drug. This study tests the efficacy, safety and tolerability of bosutinib in second-line treatment, beginning with a low dose (200 mg once daily) and adjusting subsequent doses (up to 400 mg once daily) based on molecular response and on adverse events.

Type of study

Trial after therapy failure or intolerance

Current status

Recruitment status unknown

Study sponsor

Gruppo Italiano Malattie EMatologiche dell'Adulto

Scientific lead / contact

Prof. Gianantonio Rosti
Department of Oncology and Hematology
O.U. of Hematology
S. Orsola-Malpighi University Hospital
Bologna, Italy

Principal investigator

Prof. Gianantonio Rosti
Department of Oncology and Hematology
O.U. of Hematology
S. Orsola-Malpighi University Hospital
Bologna, Italy

Additional information

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

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

Study centers / principal investigators

Italy

Ancona
S. Rupoli

Bari
G. Specchia

Bologna
S. Orsola-Malpighi University Hospital
G. Rosti

Cagliari
"A. Businco"
E. Usala

Catania
F. Stagno

Cuneo
D. Rapezzi

Ferrara
F. Cavazzini

Genova
IRCCS San Martino
M. Gobbi

Meldola
IRST
A. Lucchesi

Messina
Policlinico G. Martino
C. Musolino

Milano
Ist. Nazionale Tumori
F. Spina

Milano
Osp. Maggiore Policlinico
A.Iurlo

Milano
Ospedale San Raffaele
F. Ciceri

Napoli
Univ. Studi Napoli "Federico II"
F. Pane

Novara
M. Lunghi

Orbassano
C. Rege Cambrin

Parma
M. Crugnola

Piacenza
D. Vallisa

Ravenna
M. Salvucci

Reggio Emilia
I. Capodanno

Rimini
A. L. Molinari

Roma
Gemelli
F. Sorà

Roma
Ospedale Sant'Eugenio
E. Abruzzese

Roma
San Giovanni Addolorata
M. Cedrone

Roma
S.Camillo Forlanini Hospital
Dr. S.Mancini

San Giovanni Rotondo
N. Cascavilla

Siena
M. Bocchia

Torino
Città della salute e della scienza
D. Ferrero

Verona
M. Bonifacio

 

 

PF-114 Dose-finding Study in Ph+ CML Patients Resistant to 2nd Generation TKI or Presenting T315I Mutation [Russia]

Study title

Dose-finding Study to Evaluate the Tolerability, Safety, Pharmacokinetics and Preliminary Efficacy of PF-114 in Adult Ph+ CML Patients Resistant to 2nd Generation TKI or Presenting T315I Mutation  [Russia]

Scientific title

A Multicenter, Open Label Cohort Phase 1 Dose Finding Study to Evaluate Tolerability, Safety, Pharmacokinetics and Preliminary Efficacy of PF-114 Mesylate for Oral Administration in Adult Patients With Philadelphia Chromosome Positive (Ph+) Chronic Myeloid Leukemia (CML), Which is Resistant to the 2-nd Generation Bcr-Abl Inhibitors or Has T315I Mutation in the BCR-ABL Gene
(Clinicaltrials.gov No. NCT02885766)

Indication and most important inclusion criteria

Male or female patients 18 years of age or older with Ph+ CML in chronic phase (CP) or accelerated phase (AP) according to European LeukemiaNet guidelines (2013) can be considered for inclusion if they are intolerant to approved Bcr-Abl inhibitors or have not responded to previous treatment with at least one 2nd generation inhibitor of Bcr-Abl (dasatinib or nilotinib or bosutinib) or if they present T315I mutation in the BCR-ABL gene. In case of previous history of blast crisis phase of CML at least 6 months must have passed after the end of blast crisis phase and intake of the first dose of PF-114. To be included, patients need to have an ECOG performance status below or equal to 2 and adequate kidney, liver and heart function.

Short description of intervention

In this dose-finding study, PF-114 will be given by mouth, starting with a dose of 50 mg once daily in the first patient group. In the next patient groups, the dose is gradually increased up to 400 mg/day. The dose can be increased further based on the assessment of the safety findings by the investigators and the sponsor. 

Type of study

Trial after therapy failure or intolerance

Current status

No longer recruiting. Interim results available.

Study sponsor

Fusion Pharma LLC

Scientific lead / contact

Veronika Shulgina MD, PhD
+7 916 815 05 44
veronika.shulgina@fusion-pharma.com

Principal investigator

1. Prof. DMSci Anna Turkina
2. Elza Lomaia MD, PhD

Additional information

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

Study centers / principal investigators

Moscow
National Research Center for Hematology
Russia, 125 167, Moscow, Novii Zikovskii pr., 4

Principal Investigator:
Prof. DMSci Anna Turkina — Head of Myeloproliferative diseases
Clinical Study Coordinator:
Oleg Shuhov MD, PhD
shuhov@list.ru
+7 985 287 12 69


Moscow
Moscow City Centre of Hematology based on City Hospital named by S.Botkin
5, 2-nd Botkin's lane, build. 17, entrance 3
125284 Moscow

Principal Investigator:
Prof. DMSci Olga Vinogradova — Head of Moscow City Centre of Hematology
olgavinz@mail.ru
tel. +7(495)945-97-61


St. Petersburg
Federal Almazov North-West Medical Research Centre
Russia, 197 341, St. Petersburg, Akkuratova st., 2

Principal Investigator:
Elza Lomaia MD, PhD, — lead scientist of Onco-hematology Department
lomelza@gmail.com
+7 981 936 16 67

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