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
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
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
SUSTRENIM = Sustained Treatment-free Remission in Chronic Myeloid Leukemia [Belgium, Italy, Netherlands]
Study title
Sustained Treatment-free Remission in BCR-ABL+ Chronic Myeloid Leukemia (SUSTRENIM)
Scientific title
Sustained Treatment-free Remission in BCR-ABL+ Chronic Myeloid Leukemia: a Prospective Study Comparing Nilotinib Versus Imatinib With Switch to Nilotinib in Absence of Optimal Response. SUSTRENIM Study - GIMEMA CLM1415 (ClinicalTrials.gov NCT02602314)
Indication and most important inclusion criteria
This study includes patients who:
- have BCR-ABL1+ chronic myeloid leukemia in chronic phase (CP-CML)
- are at least 18 years old
- have an Eastern Co-Operative Group (ECOG) status of 0-2
- have adequate liver and kidney function
- have not been treated before with a BCR-Abl inhibitor for longer than 1 month or with another anticancer agent for CML for longer than 3 months.
Short description of intervention
The purpose of this study is to evaluate nilotinib compared to imatinib followed by a switch to nilotinib in newly diagnosed patients with chronic myeloid leukemia in chronic phase who do not respond optimally according to the definition by the European Leukemia Network (ELN).
Patients will receive either first-line nilotinib 300 mg twice daily by mouth or first-line imatinib 400 mg once daily by mouth. Patients intolerant to imatinib and patients without optimal response to imatinib at 3 months, at 6 months, at 12 months will be switched to nilotinib in second line. Patients with progression to accelerated or blast phase will not be switched.
Patients who achieve deep molecular remission (MR4.5) after the first two years and maintain at least MR4.0 in the first three years of the study and maintain this level in all further tests up to the end of the fourth year of therapy may qualify for treatment discontinuation and enter the treatment free remission (TFR) phase of the study. Patients who are not eligible to discontinue treatment will continue the assigned treatment.
Type of study
First line trial
Current status
Recruiting
Study sponsor
Gruppo Italiano Malattie EMatologiche dell'Adulto (GIMEMA) and stichting Hemato-Oncologie voor Volwassenen Nederland (HOVON)
Scientific lead / contact
Prof. Fabrizio Pane
Università Federico II of Naples
Italy
Principal investigator
Prof. Fabrizio Pane
Università Federico II of Naples
Italy
Additional information
Study description in the US register ClinicalTrials.gov, a service of the U. S. National Institutes of Health
Study centers / principal investigators
Belgium
Antwerpen
ZNA
Prof. Dr. P. Zachée
Brussels
Cliniques Unversitaris Sain Iuc
Prof. Fr. Havelange
Leuven
UZ Leuven
Prof. G. Verhoef
Haint-Saint-Paul
CH Jolimont
Dr. Kentos
Italy
Alessandria
S.O.C. di Ematologia
Azienda Ospedaliera
SS. Antonio e Biagio e Cesare Arrigo
Massimo Pini
Ancona
Azienda Ospedaliero - Universitaria Ospedali Riuniti Umberto I –
G.M. Lancisi - G. Salesi
Serena Rupoli
Ascoli
U.O.C. Ematologia e Terapia Cellulare - Ospedale "C. e G. Mazzoni" di Ascoli Piceno
Piero Galieni
Asti
S.O.C. di Medicina Interna B - Ospedale - Cardinal Massaia di Asti
Monia Marchetti
Avellino
Az.Ospedaliera S.G.Moscati
Fausto Palmieri
Bari
UO Ematologia con trapianto-Università degli Studi di Bari Aldo Moro
Giorgina Specchia
Barletta
UOC Ematologia Ospedale
"Monsignor Raffaele Dimiccoli"
Giuseppe Tarantini
Bergamo
Azienda Ospedaliera - Papa Giovanni XXIII
Alessandro Rambaldi
Bologna
Istituto di Ematologia "Lorenzo e A. Seragnoli"
Università degli Studi di Bologna
Policlinico S. Orsola Malpighi
Gianantonio Rosti
Brescia
USD Trapianti di midollo per adulti
Cattedra di Ematologia
Università degli Studi di Brescia
Domenico Russo
Cagliari
CTMO - Ematologia - Ospedale "Binaghi
Giorgio La Nasa
Cagliari ASL N.8 - Ospedale "A. Businco" - Struttura Complessa di Ematologia e CTMO
Emilio Usala
Campobasso
U.O.C. di Onco-Ematologia - Centro di Ricerca e Formazione ad Alta tecnologia nelle Scienze Biomediche
Sergio Storti
Catania
Università di Catania
Cattedra di Ematologia
Ospedale "Ferrarotto"
Francesco Di Raimondo
Catanzaro
Azienda Ospedaliera Pugliese Ciaccio - Presidio Ospedaliero A.Pugliese - Unità Operativa di Ematologia
Stefano Molica
Civitanova Marche
U.O. di Medicina Interna
ASUR Marche 8
Ospedale Civile
Riccardo Centurione
Cona
Azienda Ospedaliero Universitaria Arcispedale Sant'Anna
Dipartimento di Scienze Mediche Sezione di Ematologia e Fisiopatologia dell'Emostasi
Francesco Cavazzini
Cosenza
U.O. Ematologia - P.O. Annunziata - A.O. di Cosenza
Eugenio Lucia
Cuneo
S.C. Ematologia ASO S. Croce e Carle
Davide Rapezzi
Ferrara
Arcispedale Sant'Anna Dipartimento di Scienze Mediche
Sezione di Ematologia e Fisiopatologia dell'Emostasi
Francesco Cavazzini
Firenze
Unità di Ricerca e di Malattie del sangue
Ematologia San Luca Vecchio Pad. 16
Antonella Gozzini
Foggia
Struttura Complessa di Ematologia Ospedali Riuniti Foggia - Azienda Ospedaliero-Universitaria
Silvana Franca Capalbo
Genova
IRCCS AOU San Martino-
IST.Clinica Ematologica
Marco Gobbi
Latina
UOC di Ematologia con trapianto Ospedale S. Maria Goretti
Giuseppe Cimino
Lecce
ASL Le/1 P.O. Vito Fazzi
U.O. di Ematologia ed UTIE
Nicola Di Renzo
Meldola
Istituto Scientifico Romagnoli per lo Studio e la Cura dei Tumori- IRST IRCCS
Alessandro Lucchesi
Messina
Azienda Ospedaliera Universitaria Policlinico G. Martino Dipartimento di Medicina Interna
U.O. Messina
Caterina Musolino
Messina
Divisione di Ematologia - Azienda Ospedaliera Ospedali Riuniti "Papardo Piemonte" P.O. Papardo
Donato Mannina
Mestre
U.O. di Ematologia
Ospedale dell'Angelo
Renato Bassan
Milano
Unità Trapianto di Midollo Ist. Nazionale Tumori
Francesco Spina
Milano
Fondazione IRCCS Ca’ Granda Ospedale Maggiore Policlinico UOC Oncoematologia- Padiglione Marcora 2° piano
Alessandra Iurlo
Milano
Ospedale Niguarda " Ca Granda" - SC Ematologia Blocco SUD, Ponti Est, Scala E, 4° piano
Ester Pungolino
Modena
UO Ematologia - AOU Policlinico di Modena
Roberto Marasca
Napoli
Azienda Ospedaliera Universitaria
Università degli Studi di Napoli "Federico II"
Facoltà di Medicina e Chirurgia
Fabrizio Pane
Napoli
Ospedale San Gennaro
ASL Napoli 1
Lucia Mastrullo
Napoli
Azienda Ospedaliera di Rilievo Nazionale "A. Cardarelli"
Mario Annunziata
Novara
S.C.D.U. Ematologia
DIMECS e Dipartimento Oncologico
Università del Piemonte Orientale Amedeo Avogadro
Monia Lunghi
Nuoro
U.O. CTMO Ematologia - Osp. S. Francesco
Alessandro Murgia
Orbassano
Dip. di Scienze Cliniche e Biologiche
Ospedale S. Luigi Gonzaga-Medicina Interna 2
Giovanna Rege Cambrin
Padova
Università degli Studi di Padova - Ematologia ed Immunologia Clinica
Gianni Binotto
Pagani (SA)
U.O. di Oncoematologia di Nocera Inferiore-plesso ospedaliero "A. Tortora" di Pagani del DEA Nocera-Pagani
Paolo Danise
Palermo
Ospedali Riuniti "Villa Sofia-Cervello"
Francesco Fabbiano
Palermo
U.O. di Ematologia con trapianto
Dipart. Biomedico di Medicina Interna A.U. Policlinico "Paolo Giaccone"
Sergio Siragusa
Parma
Cattedra di Ematologia CTMO Università degli Studi di Parma
Monica Crugnola
Pesaro
Div. di Ematologia di Muraglia - CTMO Ospedale San Salvatore
Giuseppe Visani
Pescara
U.O. Ematologia Clinica - Azienda USL di Pescara
Paolo Di Bartolomeo
Piacenza
Unità Operativa
Dipartimento di Oncologia ed Ematologia
AUSL Ospedale G. da Saliceto
Daniele Vallisa
Potenza
Ematologia - Ospedale San Carlo
Michele Pizzuti
Ravenna
Dipartimento Oncologico
Ospedale S.Maria delle Croci
Maria Salvucci
Reggio Calabria
Dipartimento Emato-Oncologia A.O."Bianchi-Melacrino-Morelli"
Bruno Martino
Reggio Emilia
Unità Operativa Complessa di Ematologia
Arcispedale S. Maria Nuova
Paolo Avanzini
Rimini
Ematologia di Rimini - Ospedale "Infermi" – ASL Romagna
Anna Lia Molinari
Roma
Az. Ospedaliera "Sant' Andrea"-Università la Sapienza
Seconda Facoltà di Medicina e Chirurgia
Agostino Tafuri
Roma
Divisione Ematologia
Università Campus Bio-Medico
Marianna De Muro
Roma
Università Cattolica del Sacro Cuore Policlinico A. Gemelli
Simona Sica
Roma
UOC Pronto Soccorso
Dipartimento Biotecnologie Cellulari ed Ematologia
Università degli Studi di Roma "Sapienza"
Massimo Breccia
Roma
U.O.C. Ematologia - Ospedale S. Eugenio
Elisabetta Abruzzese
Roma
Università degli Studi -
Policlinico di Tor Vergata
Maria Cantonetti
Rossano (CS)
Unità Operativa di Oncologia -
Presidio Ospedaliero N. Giannetasio - Azienda ASL 3
Francesco Iuliano
Salerno
UOC di Ematologia e Trapianti di Cellule Staminali Emopoietiche - AOU San Giovanni di Dio e Ruggi D'Aragona
Carmine Selleri
San Giovanni Rotondo
Istituto di Ematologia
IRCCS Ospedale Casa Sollievo della Sofferenza
Nicola Cascavilla
Sassari
Ematologia
Dipartimento di Medicina Clinica e Sperimentale
Claudio Fozza
Siena
U.O.C. Ematologia e Trapianti - A.O. Senese - Policlinico " Le Scotte"
Monica Bocchia
Terni
A.O. Santa Maria
Terni S.C Oncoematologia
Anna Marina Liberati
Torino
Divisione di Ematologia dell' Università degli Studi di Torino - "Città della Salute e della Scienza di Torino"
Dario Ferrero
Torino
Dipartimento di Oncologia ed Ematologia S.C. Ematologia 2 A.O. Città della Salute e della Scienza di Torino San Giovanni Battista
Patrizia Pregno
Torino
Struttura Complessa a Dir. Universitaria-Ematologia e Terapie Cellulari
A.S.O. Ordine Mauriziano, P.O. Umberto I
Ospedale Torino
Carmen Fava
Treviso
U.L.S.S. 9 UOC Ematologia -
Ospedale Ca' Foncello
Filippo Gherlinzoni
Udine
Clinica Ematologica
Centro Trapianti e Terapie cellulari Azienda Ospedaliero-Universitaria
Mauro Tiribelli
Varese
Medicina Interna I - Ospedale di Circolo
Leonardo Campiotti
Verona
Università degli Studi di Verona
A. O. - Istituti Ospitalieri di Verona
Div. di Ematologia
Policlinico G.B. Rossi
Massimiliano Bonifacio
Vicenza
ULSS N.6 Osp. S. Bortolo
Eros Di Bona
Netherlands
Amersfoort
Meander MC
Dr. S. K. Klein
Amsterdam
VUMC
Dr. JJWM Janssen
Delft
Reinier de Graaf Gasthuis
Dr. E Posthuma
Den Bosch
Jeroen Bosch Ziekenhuis
Dr. A. Herbers
Dordrecht
A. Schweitzer ZH, Dordwijk
Dr. P. Westerveel
Heerlen-Sittard-Geleen
Zuyderland Medical Center
Dr. G. Jie
Hoofddorp
Spaarne Ziekenhuis
I. Houtenbos
Leiden
Leids Universitair Medisch Centrum
Dr. P. Balen
Nijmegen
Radboudumc
Prof. Dr. N. Blijlevens
Utrecht
UMCU
Dr. Petersen
Zwolle
Isala
Dr. M. van Markwijk Kooy
KISS = Kinase Inhibition With Sprycel Start up [New Zealand]
Study title
KISS: Kinase Inhibition With Sprycel Start up
Scientific title
KISS Study: A Phase II Study of Dasatinib Followed by Imatinib in Newly Diagnosed, Previously Untreated Patients With Chronic Phase CML (ClinicalTrials.gov NCT03193281)
Indication and most important inclusion criteria
This study includes male or female patients who:
- are at least 18 years old
- have an Eastern Co-Operative Oncology Group (ECOG) status of 0, 1 or 2
- have been diagnosed with chronic myeloid leukemia in chronic phase within 3 months of enrolment
- have cytogenetic or molecular confirmation of Philadelphia chromosome (Ph+) or variants of (9;22) translocations
Short description of intervention
This study will assess the efficacy and safety of a treatment plan for patients with newly diagnosed CML-CP. In the first study stage, patients will be given dasatinib (Sprycel) to more rapidly induce a molecular response (MR3.0). At 13 months, patients will be switched to imatinib to maintain CML in that remission.
Patients who do not achieve confirmed MR3.0 at 13 months will not be eligible to switch to imatinib treatment and will continue on dasatinib treatment.
Type of study
First line trial
Current status
Recruiting
Study sponsor
University of Auckland, New Zealand, in collaboration with Leukaemia & Blood Cancer, New Zealand
Scientific lead / contact
Professor Peter Browett, University of Auckland, New Zealand
Principal investigator
Professor Peter Browett, University of Auckland, New Zealand
Additional information
Study description in the US register ClinicalTrials.gov, a service of the U. S. National Institutes of Health
Study centers / principal investigators
New Zealand
Auckland City Hospital
Auckland
Principal Investigator: Prof Peter Browett
Middlemore Hospital
Auckland
Principal Investigator: Dr Gordon Royle
Christchurch Hospital
Christchurch
Principal Investigator: Dr Emma Jane McDonald
Dunedin Hospital
Dunedin
Principal Investigator: Dr Lucy Pemberton
Waikato Hospital
Hamilton
Principal Investigator: Humphrey Pullon
Taranaki Base Hospital
New Plymouth
Principal Investigator: Bart Baker
Palmerston North Hospital
Palmerston North
Principal Investigator: Bart Baker
North Shore Hospital
Takapuna
Principal Investigator: Henry Chan
Wellington Hospital
Wellington
Principal Investigator: Michelle Dickson
Low Dose Dasatinib as First-Line Treatment [Middle East]
Study title
LPI-JOR-LEB-KSA-TUN-2017-01 = Low Dose Dasatinib (50 mg Daily) as First-line Treatment for Newly Diagnosed Chronic‐Phase Chronic Myeloid Leukemia
Scientific title
Randomized, Open-Label, Phase II, Multicenter, Multi-Country Study to Evaluate Safety and Efficacy of Dasatinib 50 mg in First-Line Treatment of Early Chronic Phase Chronic Myeloid Leukemia (ClinicalTrials.gov no NCT03625388)
Indication and most important inclusion criteriaRandomized, Open-Label, Phase II, Multicenter, Multi-Country Study to Evaluate Safety and Efficacy of Dasatinib 50 mg in First-Line Treatment of Early Chronic Phase Chronic Myeloid Leukemia (ClinicalTrials.gov n
This study includes patients aged 18 years and above who were diagnosed with Philadelphia chromosome-positive (Ph+) or BCR-ABL positive chronic myeloid leukemia (CML) in chronic phase (CP) within the past 12 months. Except for hydroxyurea and/or 1-2 doses of cytarabine (up to 6 g/m2 total), patients must have received no or minimal prior therapy, defined as 30 days of prior approved tyrosine kinase inhibitor (TKI). To be included patients must also have a score of 0-2 on the ECOG performance scale assessing the quality of life of cancer patients. End organ function must be adequate.
Patients with clonal evolution and no other criteria for accelerated phase (AP) will be eligible for this study.
Other criteria may apply.
Short description of intervention
The aim of this study is to compare the efficacy and safety of dasatinib 50 mg once daily and dasatinib 50 mg once daily in patients with early chronic phase (CP) chronic myeloid leukemia (CML).
Type of study
First line trials
Current status
Recruiting
Study sponsor
Hikma Pharmaceuticals LLC
Scientific lead / contact
Hikma Pharmaceuticals
medical-information@hikma.com
Principal investigator
Multiple
Additional information
Study description in the US register ClinicalTrials.gov, a service of the U. S. National Institutes of Health
Study centers / principal investigators
Jordan
King Hussein Cancer Center (KHCC)
Amman, 11941
Jordan University Hospital (JUH)
Amman, 11942
Lebanon
American University of Beirut Medical Center (AUBMC)
Beirut
Saudi Arabia
The King Faisal Specialist Hospital and Research Centre (KFSH&RC)
Riyadh
Tunisia
Aziza Othmana Hospital
Tunis, 1006
TIPI = Ponatinib followed by Imatinib in Chronic Phase Chronic Myeloid Leukemia [France]
Study title
Safety and Efficacy of Ponatinib Followed by Imatinib in Patients With Chronic Myelogenous Leukemia in Chronic Phase (ET18000120; TIPI)
Scientific title
A Multicentre, Open-label Phase II Trial Evaluating the Safety and Efficacy of Ponatinib Induction Followed by Imatinib Maintenance in Adult Patients With Chronic Myelogenous Leukemia in Chronic Phase (CML-CP) ≤ 65 Years (ClinicalTrials.gov no NCT04070443)
Indication and most important inclusion criteria
This study includes patients aged 18 to 65 years who were diagnosed with Philadelphia chromosome-positive (Ph+) with or without additional chromosomal abnormalities and/or BCR-ABL positive chronic myeloid leukemia (CML) in chronic phase (CP) within the past 2 months. Except for hydroxyurea and/or anagrelide, patients must have received no prior treatment for CML. To be eligible for inclusion, patients must also have a an intermediate or high EUTOS long-term survival Score. Kidney and liver function must be adequate.
Other criteria may apply.
Short description of intervention
This study is conducted to evaluate the safety, clinical and biological activity of an induction treatment with ponatinib 30 mg/day for 6 months, followed by a consolidation treatment with imatinib 400 mg/day in newly diagnosed de novo chronic phase CML patients.
The aim is to determine whether this treatment sequence increases the rate of patients reaching a stable MR4.5 allowing discontinuation of imatinib treatment.
Type of study
First line trials
Current status
Recruiting
Study sponsor
Centre Léon Bérard
Scientific lead / contact
Franck-Emmanuel NICOLINI, MD
Centre Léon Bérard
Principal investigator
Franck-Emmanuel NICOLINI, MD
Centre Léon Bérard
Additional information
Study description in the US register ClinicalTrials.gov, a service of the U. S. National Institutes of Health
Study centers / principal investigators
France
CHU Amiens Picardie
Amiens, 80000
Principal Investigator: Amandine Charbonnier, MD
CHU d'Angers
Angers
Principal Investigator: Martine Gardemba-Pain, MD
Centre Hospitalier Annecy-Genevois
Annecy, 74000
Principal Investigator: Pascale Cony-Makhoul, MD
CH d'Avignon
Avignon, 84000
Principal Investigator: Hacène Zerazhi, MD
Chru Besançon
Besançon, France, 25000
Principal Investigator: Marion Simonet-Boissard, MD
Institut Bergonie
Bordeaux, 33000
Principal Investigator: Gabriel Etienne, MD
Institut D'Hematologie de Basse Normandie
Caen, 14000
Principal Investigator: Hyacinthe Atchroué Johnson-Ansah, MD
CHU D'Estaing
Clermont-Ferrand, 63000
Principal Investigator: Marc Berger, MD
Centre Hospitalier Sud Francilien
Corbeil-Essonnes, 91000
Principal Investigator: Bertrand Joly, MD
Hopital Henri Mondor
Créteil, 94000
Principal Investigator: Lydia Roy, MD
CHU de Grenoble
Grenoble, 38000
Principal Investigator: Stéphane Courby, MD
CH de Versailles - Hôpital André Mignot
Le Chesnay
Principal Investigator: Philippe Rousselot, MD
Hôpital Claude Huriez - CHRU de Lille
Lille
Principal Investigator: Valérie Coiteux, MD
CHU Limoges - Hôpital Dupuytren
Limoges
Principal Investigator: Pascal Turlure, MD
Centre Léon Bérard
Lyon, 69008
Principal Investigator: Franck-Emmanuel Nicolini, MD
Hopital Saint Eloi
Montpellier, 34000
Principal Investigator: Philippe Quittet, MD
Chu Hotel Dieu
Nantes, 44000
Principal Investigator: Viviane Dubruille, MD
CHU Nîmes Caremeau - Institut de Cancérologie du Gard
Nîmes
Principal Investigator: Eric Jourdan, MD
Hopital Saintantoine
Paris, 75000
Principal Investigator: Simona Lapusan, MD
CHU Poitiers
Poitiers
Principal Investigator: Emilie Cayssials, MD
CHU - Hopital de Pontchaillou
Rennes, 35000
Principal Investigator: Martine Escoffre-Barbe, MD
Institut de Cancérologie Lucien Neuwirth
Saint-Priest-en-Jarez
Principal Investigator: Denis Guyotat, MD
Institut de cancérologie Strasbourg Europe
Strasbourg, 67000
Principal Investigator: Shanti Natarajan-Ame, MD
Iuct Toulouse - Oncopole
Toulouse
Principal Investigator: Françoise Huguet, MD
CHRU Nancy/Brabois
Vandœuvre-lès-Nancy, 54500
Principal Investigator: Agnès Guerci-Bresler, MD
Hopital Paul Brousse
Villejuif, France, 94800
Principal Investigator: Laurence Legros, MD
RERISE China = Radotinib versus Imatinib [China]
Study title
Randomized Evaluation of Radotinib Versus Imatinib for Efficacy (RERISE China)
Scientific title
A Phase III, Multi-center, Open-Label, Randomized Study of the Efficacy of Radotinib Versus Imatinib in Newly Diagnosed Philadelphia Chromosome Positive (Ph+) Chronic Myeloid Leukemia Chinese Patients in Chronic Phase (RERISE China) (ClinicalTrials.gov no. NCT03722420)
Indication and most important inclusion criteria
This study includes male or female patients who:
- are at least 18 years old
- have an Eastern Co-Operative Oncology Group (ECOG) status of 0, 1 or 2
- have been diagnosed with chronic myeloid leukemia (CML) in chronic phase (CP) within 6 months of enrolment
- have cytogenetically confirmed Philadelphia chromosome (Ph+) CML and typical BCR-ABL1 transcript such as b2a2 and b3a2
- have adequate organ function
Other criteria may apply.
Short description of intervention
This study will evaluate the efficacy of radotinib compared to imatinib 300 mg twice a day compared to imatinib 400 mg in patients with Ph+ CML in chronic phase.
Patients will be randomized to receive either radotinib 300 mg twice daily by mouth or imatinib 400 mg once a day by mouth. All patients will be treated and/or followed for 12 months (48 weeks) after randomization.
Type of study
First line trial
Current status
Recruiting
Study sponsor
Il-Yang Pharm. Co., Ltd.
Scientific lead / contact
Jeong Hye Kim, Il-Yang Pharm. Co., Ltd.
Bo Hwangbo, Il-Yang Pharm. Co., Ltd.
Principal investigator
Jiang Qian
Peking University People's Hospital
Additional information
Study description in the US register ClinicalTrials.gov, a service of the U. S. National Institutes of Health
Study centers / principal investigators
China
Peking University People's Hospital
Beijing, 100044
Principal Investigator: Jiang Qian