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

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


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 description and study flowchart on the website of the Dutch foundation stichting Hemato-Oncologie voor Volwassenen Nederland (HOVON)

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

 

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

Institut Bergonie
Bordeaux, 33000
Principal Investigator: Gabriel Etienne, MD

CHU de Grenoble
Grenoble, 38000
Principal Investigator: Stéphane Courby, MD

Centre Léon Bérard
Lyon, 69008
Principal Investigator: Franck-Emmanuel Nicolini, MD

Iuct Toulouse - Oncopole
Toulouse,
Principal Investigator: Françoise Huguet, MD

CHRU Nancy/Brabois
Vandœuvre-lès-Nancy, 54500
Principal Investigator: Agnès Guerci-Bresler, MD

The trial will be expanded to all SOKAL and ELTS (EUTOS long-term survival) patients if there no safety warnings after the first patients in 2020. Further sites will be opened in France and Switzerland. 

RERISE China = Radotinib versus Imatinib [China]

Study title

Randomized Evaluation of Radotinib Versus Imatinib for Efficacy (RERISE China)

Scientific title

Randomized Evaluation of Radotinib Versus Imatinib in Phase III Study for Efficacy With Chinese Patients (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

 

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