DASCERN (CA180-399) = Phase IIb Study of Dasatinib versus Imatinib (Early Switch)
Study title
Phase IIb Study of Dasatinib Versus Imatinib in Patients With Chronic Phase Chronic Myeloid Leukemia (CML-CP) Who Have Not Achieved an Early Optimal Response to Imatinib (Early switch) [Asia, Europe, North America, South America]
Scientific title
An Open Label, Randomized (2:1) Phase IIb Study of Dasatinib Versus Imatinib in Patients With Chronic Phase Chronic Myeloid Leukemia Who Have Not Achieved an Optimal Response to 3 Months of Therapy With 400 mg Imatinib
(EudraCT/Clinicaltrials.gov No. NCT01593254)
Indication and most important inclusion criteria
This study includes Philadelphia chromosome positive (Ph+) patients with Chronic Phase Chronic Myeloid Leukemia (CML-CP) who have achieved Complete Hematologic Response (CHR) but with BCR-ABL >10% International Standard (IS) after 3 months of Imatinib 400 mg treatment. Patients must have started treatment with Imatinib within 6 months of CP-CML diagnosis and currently tolerate Imatinib 400 mg once daily. They must not have received any CML treatment other than Imatinib. To be considered for inclusion in this study, patients must be at least 18 years old, should have an Eastern Co-Operative Group (ECOG) performance status of 0 - 2 as well as adequate kidney and liver function.
Short description of intervention
The purpose of this study is to find out whether CP-CML patients with BCR-ABL > 10% IS after 3 months of treatment with first line Imatinib 400 mg will achieve a greater rate of major molecular response (MMR) by early switching to Dasatinib therapy 100 mg once daily compared with continued treatment with Imatinib at any dose.
Patients in Group 1 will receive:
Imatinib ≥ 400 mg tablets by mouth once daily or twice daily depending on the dose selected, up to 84 months
Patients in Group 2 will receive:
Dasatinib 100 mg tablet by mouth once daily up to 84 months
Type of study
Trials after treatment failure
Current status
No longer recruiting patients
Study sponsor
Bristol-Myers Squibb
Scientific lead / contact
Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email: Clinical.Trials@bms.com
Contact: First line of the email MUST contain NCT01593254 and Site #.
Principal investigator
See site locations
Additional information
Study description in the US register ClinicalTrials.gov, a service of the U. S. National Institutes of Health
Study centers / principal investigators
Argentina
Local Institution
Buenos Aires, C1431FWO
Contact: Site 0051
Local Institution
Buenos Aires, 1221
Contact: Site 0080
Local Institution
Ciudad de Buenos Aires, C1114AAP
Contact: Site 0080
Local Institution
Corrientas, Argentina, Provincia de Corientas, 3400
Contact: Site 0100
Local Institution
La Plata, Buenos Aires, B1900
Contact: Site 0093
Local Institution
San Miguel de Tucuman, Tucuman, 4000
Contact: Site 0049
Local Institution La Plata,
Buenos Aires, B1900
Contact: Site 0093
Local Institution
San Miguel de Tucuman, Tucuman, 4000
Contact: Site 0049
Local Institution
La Plata, Buenos Aires, B1900
Contact: Site 0093
Local Institution
San Miguel de Tucuman, Tucuman, 4000
Contact: Site 0049
Austria
Local Institution
Fürstenfeld, 8280
Contact: Site 0066
Local Institution
Graz, 8036
Contact: Site 0043
Local Institution
Innsbruck, 6020
Contact: Site 0026
Local Institution
Linz, 4010
Contact: Site 0024
Local Institution
Wels, 4600
Contact: Site 0022
Local Institution
Wien, 1090
Belgium
Local Institution
Antwerpen, 2060
Contact: Site 0099
Local Institution
Brugge, 8000
Contact: Site 0065
Local Institution
Yvoir, 5530
Contact: Site 0029
Brazil
Local Institution
Goiania, Goias, 74605-020
Contact: Site 0083
Local Institution
Campinas - SP, Sao Paulo, CEP13083-878
Contact: Site 0063
Local Institution
Curittiba-PR, CEP 80060-900
Contact: Site 0063
Local Institution
Ribeirao Preto, Sao Paulo, 14048
Contact: Site 0061
Local Institution
Rio de Janeiro, 20211
Contact: Site 0062
Local Institution
Rio de Janeiro, 230-130
Contact: Site 0058
Local Institution
Sao Paulo, 08270
Contact: Site 0059
Canada
Local Institution
Saint John, New Brunswick, E2L 4L2
Contact: Site 0020
China
Local Institution
Beijing, Beijing, 100034
Contact: Site 0071
Local Institution
Fuzhou, Fujian, 350001
Contact: Site 0070
Local Institution
Guangzhou, Guangdong, 510515
Contact: Site 0074
Local Institution
Guangzhou, Guangdong, 510080
Contact: Site 0082
Local Institution
Ha'erbin, Heilongjiang, 150010
Contact: Site 0084
Local Institution
Wuhan, Hubei, 430022
Contact: Site 0096
Local Institution
Wuhan, Hubei, 430030
Contact: Site 0102
Local Institution
Nanjing, Jiangsu, 210029
Contact: Site 0073
Local Institution
Soochow, Jiangsu, 215006
Contact: Site 0077
Local Institution
Shenyang, Liaoning, 110001
Contact: Site 0094
Local Institution
Shanghai, Shanghai, 200025
Contact: Site 0076
Local Institution
Chengdu City, Sichuan, 610041
Contact: Site 0075
Local Institution
Tianjin, Tianjin, 300020
Contact: Site 0069
Local Institution
Hangzhou, Zhejiang, 310003
Contact: Site 0072
Local Institution
Beijing, 100071
Contact: Site 0086
Local Institution
Xi'an, 710032
Contact: Site 0088
Local Institution
Jinan, 250012
Contact: Site 0101
Czech Republic
Local Institution
Brno, 625 00
Contact: Site 0032
Local Institution
Olomouc, 775 20
Contact: Site 0056
Local Institution
Prague 2, 128 20
Contact: Site 0067
Local Institution
Praha 10, 100 34
Contact: Site 0031
France
Local Institution
Le Chesnay Cedex, 78157
Contact: Site 0045
Local Institution
Lille CEDEX, 59037
Contact: Site 0041
Local Institution
Nantes Cedex 1, 44000
Contact: Site 0035
Local Institution
Pierre Benite cedex, 69495
Contact: Site 0037
Local Institution
Pringy Cedex, 74374
Contact: Site 0081
Local Institution
Vandoeuvre les Nancy, 54511
Contact: Site 0038
Italy
Local Institution
Bari, 70124
Contact: Site 0092
Local Institution
Bologna, 40138
Contact: Site 0044
Local Institution
Catania, 95124
Contact: Site 0034
Local Institution
Firenze, 50134
Contact: Site 0027
Local Institution
Monza, 20900
Contact: Site 0046
Local Institution
Napoli, 80131
Contact: Site 0053
Local Institution
Orbassano, Torino, 10043
Contact: Site 0025
Local Institution
Roma, 00144
Contact: Site 0021
Local Institution
Roma, 00161
Contact: Site 0033
Korea, Republic of
Local Institution
Seoul, 135-710
Contact: Site 0039
Local Institution
Seoul, 137-701
Contact: Site 0050
Local Institution
Seoul, 138-736
Contact: Site 0040
Poland
Local Institution
Gdansk, Poland, 80-952
Contact: Site 0047
Local Institution
Katowice, 40-032
Contact: Site 0098
Local Institution
Krakow, 30-510
Contact: Site 0048
Local Institution
Warszawa, 02-776
Contact: Site 0064
Spain
Local Institution
Las Palmas de Gran Canaria, 35010
Contact: Site 0015
Local Institution
L'Hospitalet del Llobregat, 08908
Contact: Site 0018
Local Institution
Madrid, 28007
Contact: Site 0012
Local Institution
Salamanca, Castilla Leon, 37007
Contact: Site 0013
Local Institution
Santiago de Compostela, 15706
Contact: Site 0017
Local Institution
Toledo, 45004
Contact: Site 0011
Thailand
Local Institution
Bangkok, 10400
Contact: Site 0054
Local Institution
Chiang Mai, 50200
Contact: Site 0055
Local Institution
Khon-Kaen, 40002
Contact: Site 0052
United States
California
Pacific Cancer Medical Center Inc
Anaheim, California, 92801
Contact: Ajit Maniam, Site 0004
Southern California Permanente Medical Group
BellFlower, California, 90706
Contact: Han Koh, Site 0006
Kaiser Permanente Medical Center
Vallejo, California, 94589
Contact: Louis Fehrenbacher, Site 0009
Innovative Clinical Research Institute
Whittier, California, 90603
Contact: Richy Agajanian, Site 0078
Connecticut
Cancer Center Of Central Connecticut
Southington, Connecticut, 06489
Contact: Peter Byeff, Site 0089
Indiana
Northern Indiana Cancer Research Consortium
Crown Point, Indiana, 46307
Franciscan Physiscian Network Oncology And Hematology Services
Indianapolis, Indiana, 46237
Contact: S. Rubenstein, Site 0003
Iowa
University Of Iowa Hospitals And Clinics
Iowa City, Iowa, 52242
Contact: Usha Perepu, Site 0090
Minnesota
Mayo Clinic
Rochester, Minnesota, 55905
Contact: Aref Al-Kali, Site 0010
Ohio
Oncology Hematology Care, Incorporated
Cincinnati, Ohio, 45242
Contact: James Essell, Site 0002
Tennessee
Sarah Cannon Research Institute
Nashville, Tennessee, 37203
Contact: Ian Winchester Flinn, Site 0001
Texas
Michael E Debakey Va Medical Center
Houston, Texas, 77030
Contact: Sarvari Yellapragada, Site 0079
West Virginia
Edwards Comprehensive Cancer Center-University Oncology Services
Huntington, West Virginia, 25701
Contact: Mohamad Khasawneh, Site 0016
Wisconsin
Froedtert Medical College Of Wisconsin
Milwaukee, Wisconsin, 53226
Contact: Ehab Atallah, Site 0005 414-805-4600
DECLINE (CAMN107ADE18T) = Imatinib versus nilotinib in CML in chronic phase [Germany]
Study title
DECLINE = Imatinib versus nilotinib in CML in chronic phase
Scientific title
Imatinib continuation versus Nilotinib 300 mg twice daily in patients with chronic myeloid leukemia (CML) in chronic phase and major molecular re-sponse (MMR) without molecular response ≥ 4.5 log (MR4.5) receiving Imatinib at a dose of 400 to 800 mg daily. An open-label, randomised multicenter phase 3b study to determine the confirmed rate of molecular response ≥ 4 log (MR4) at two years (EudraCT 2013-000077-68, ClinicalTrials.gov NCT02174445, DRKS00006285)
Indication and most important inclusion criteria
Male or female patients (≥18 years) with CML in first chronic phase (defined as blasts <15% in blood or bone marrow and peripheral blood basophils <20% and platelets ≥ 100 G/L) receiving Imatinib at the standard dose of 400 to 800 mg daily for at least 18 months before informed consent.
Major molecular response (MMR) without molecular response ≥ 4.5 log (MR4.5), i.e. BCR-ABL>0.0032% and ≤0.1% IS confirmed by central laboratory at screening will be required for randomization.
Short description of intervention
This study was designed for patients with CML who have achieved major molecular response on treatment with imatinib but do not qualify for investigational treatment discontinuation since they do not reach ongoing CMR.
Goal of the study is to investigate whether in patients with CML in 1st chronic phase and confirmed MMR receiving imatinib (400 mg daily) a switch to nilotinib (300 mg twice daily) results in a higher proportion of patients with confirmed conversion from MMR to MR4 after two years of study treatment when compared with patients who continue receiving Imatinib (400 mg daily). The study duration for each individual may vary between 27 and 72 months.
Type of study
Therapy optimization trial
Current status
No longer recruiting
Study sponsor
University Medical Center Freiburg
(with financial support from Novartis)
Scientific lead / contact
Prof. Dr. med. Nikolas von Bubnoff
Principal investigator
Prof. Dr. med. Nikolas von Bubnoff
Universitätsklinikum Freiburg
Additional information
Patient Information Sheet in German
Study centers / principal investigators
Germany
Aachen
Universitätsklinikum Aachen
Medizinische Klinik IV, Hämatologie
Pauwelstr. 30
52074 Aachen
Augsburg
Praxis Dr. Bruder / Dr. Heinrich / Prof. Bangerter
Halderstraße 29
86150 Augsburg
Bonn
Universitätsklinikum Bonn
Medizinische Klinik III
Abteilung für Hämatologie und Onkologie
Sigmund-Freud-Str. 25
53105 Bonn
Dresden
Gemeinschaftspraxis
Arnoldstr. 18
01307 Dresden
Erfurt
Praxis Dr. Hauch
Neuwerkstraße 51
99084 Erfurt
Erlangen
Internistische Schwerpunktpraxis Erlangen
oncosearch
Nägelsbachstraße 49c
91052 Erlangen
Essen
Praxis für Hämatologie/Onkologie
Dres. Rudolph, Sengpiel, von Verschuer
Henricistraße 40
45136 Essen
Freiburg
Universitätsklinikum Freiburg
Medizinische Klinik I
Hugstetter Straße 55
79106 Freiburg
Hamburg
Universitätsklinikum Hamburg-Eppendorf
II. Medizinische Klinik und Poliklinik
Onkologisches Zentrum
Martinistr. 52
20246 Hamburg
Jena
Universitätsklinikum Jena
Klinik für Innere Medizin III
Erlanger Allee 101
07747 Jena
Köln
Universitätsklinik Köln
Klinik I für Innere Medizin
Kerpener Str. 62, Haus 16
50937 Köln
Magdeburg
Gemeinschaftspraxis
Hämatologie/Onkologie
Hasselbachplatz 2
39104 Magdeburg
Mannheim
Klinikum Mannheim GmbH
Universitätsklinikum
III. Medizinische Klinik
Theodor-Kutzer-Ufer 1-3
68167 Mannheim
München
Technische Universität München
Klinikum rechts der Isar,
III. Medizinische Klinik und Poliklinik
Ismaninger Str. 22
81675 München
München-Pasing
Hämato-Onkologische
Überörtliche Gemeinschaftspraxis Pasing und Fürstenfeldbruck
Bäckerstrasse 4
81241 München
Oldenburg
Onkologische Praxis Oldenburg
Dres. Otremba, Reschke, Zirpel, Kühn
Grüne Straße 11
26121 Oldenburg
Saarbrücken
Medizinische Statistik Saarbrücken, GbR
Dr. Jacob, Prof. Daus, PD Dr. Schmits
Europaallee 5 (Alter Lokschuppen)
66113 Saarbrücken
Ulm
Universitätsklinikum Ulm
Zentrum Innere Medizin
Albert-Einstein-Allee 23
89081 Ulm
Ruxolitinib for CML with minimal residual disease [USA]
Study title
Ruxolitinib for Chronic Myeloid Leukemia (CML) with Minimal Residual Disease (MRD)
Scientific title
Phase I-II Study of Ruxolitinib (INCB18424) for Patients With Chronic Myeloid Leukemia (CML) With Minimal Residual Disease While on Therapy With Tyrosine Kinase Inhibitors
(ClinicalTrials.gov NCT01751425)
Indication and most important inclusion criteria
Potential study participants must be 18 years or older and have Philadelphia chromosome (Ph)-positive or BCR/ABL-positive CML. They have been receiving imatinib (once the maximum tolerated dose (MTD) has been established, patients receiving dasatinib or nilotinib also eligible) for at least 18 months with no increase in their dose for the last 6 months.
Patients with some response to tyrosine kinase inhibitor (TKI) but persistent minimal residual disease are eligible. In the phase 1 portion of the study only patients receiving imatinib who have at least a complete hematologic response are eligible. Once MTD is determined, patients with nilotinib or dasatinib are also eligible. For the phase 2 portion of the study only patients with complete cytogenetic response are eligible provided they have detectable disease.
Short description of intervention
This study consists of two parts. The goal of the first part is to find the highest tolerable dose of ruxolitinib that can be given with a tyrosine kinase inhibitor that patients are already taking as part of their standard treatment. The goal of the second part of this study is to learn if this drug combination can help to control CML in patients in whom, despite a good response to therapy, the disease is still detectable at low levels (this is called "minimal residual disease"). Researchers believe that eliminating all detectable evidence of disease may decrease the chances that the leukemia will ever come back. The safety of the drug combination will also be studied in both parts.
Type of study
Therapy optimization trial
Current status
Active, not recruiting
Study sponsor
M.D. Anderson Cancer Center
In collaboration with
Incyte Corporation
Scientific lead / contact
Jorge Cortes, MD
Principal investigator
Jorge Cortes, MD
Additional information
Study description in the US register ClinicalTrials.gov, a service of the U. S. National Institutes of Health
Study centers / principal investigators
United States
UT MD Anderson Cancer Center
Houston, Texas, 77030
Jorge Cortes, MD
LEONIDAS = Quality-of-Life effects of imatinib and dasatinib in CML
Study title
LEONIDAS [Europe]
Scientific title
Mid to Long-term Quality of Life Effects Of imatiNIb versus DASatinib in Chronic Myeloid Leukemia Patients (LEONIDAS) (Clinicaltrials.gov No. NCT02164903)
Indication and most important inclusion criteria
Adult Patients (18 years or older at the time of study entry) with chronic phase chronic myeloid leukaemia (CP-CML) who are receiving either dasatinib or imatinib as first line trearment for no more than 3 years and who have already achieved complete cytogenetic response (CCyR).
To be considered for inclusion in this study, patients must not have received any other CML treatment prior to imatinib or dasatinib therapy for more than three months. Patients must be able to perform a self-reported evaluation.
Short description of intervention
This study investigates if differences exist in Quality of Life (QoL) and symptoms of patients with CML being treated with first line therapy with dasatinib compared to those receiving first line therapy with imatinib. Another objective is to characterize medication-taking behavior (adherence) associated with imatinib or dasatinib.
Type of study
Other studies
In multiple countries
Current status
No longer recruiting patients
Study sponsor
GIMEMA Foundation
(Italian Group for Adult Hematologic Diseases)
Scientific lead / contact
Dr. Fabio Efficace
Dr. Gianantonio Rosti
mail: leonidas@gimema.it
Principal investigator
Dr. Fabio Efficace
Dr. Gianantonio Rosti
Additional information
Study synopsis (short summary)
Study description in the US register ClinicalTrials.gov, a service of the U. S. National Institutes of Health
Study centers / principal investigators
France
Le Chesnay
Department of Hematology and Oncology
Hôpital Mignot
Université Versailles Saint-Quentin-en-Yvelines
Philippe Rousselot
not yet recruiting
Germany
Mannheim
Universität Heidelberg
III. Medizinische Klinik – Universitätsmedizin Mannheim
Susanne Saussele
Italy
Alessandria
S. C. di Ematologia - Azienda Ospedaliera
SS. Antonio e Biagio e Cesare Arrigo
Flavia Salvi
Ancona
Clinica di Ematologia
Azienda Ospedaliera Regionale di Torrette
Serena Rupoli
Bari
U.O. Ematologia con trapianto
Azienda Ospedaliero-Universitaria Policlinico di Bari
Giorgina Specchia
Bologna
Istituto di Ematologia "L. e A. Seragnoli"
Università degli Studi di Bologna - Policlinico S. Orsola – Malpighi
Gianantonio Rosti
Brescia
USD - Centro Trapianti Midollo Osseo Adulti - Cattedra di Ematologia
Azienda Spedali Civili – Brescia
Domenico Russo
Brindisi
U.O. Ematologia Brindisi
Ospedale A. Perrino ASL BR
Angela Melpignano
Cagliari
CTMO-Ematologia
Ospedale "Binaghi"
Giovanni Caocci
Cagliari
U.O. Ematologia
CTMO "Businco"
Emilio Usala
Catania
Divisione clinicizzata di Ematologia
Dipartimento di Scienze Mediche - Osp. Ferrarotto
Francesco Di Raimondo
Ferrara
Azienda Ospedaliera
Arcispedale S. Anna Sezione di Ematologia e Fisiopatologia delle Emostasi
Francesco Cavazzini
Firenze
Divisione di Ematologia
Policlinico Careggi
Alberto Bosi
Genova
Clinica Ematologica - Dipartimento di Medicina Interna
IRCCS San Martino – IST
Marco Gobbi
Messina
Divisione Ematologia - Dipartimento di Medicina Interna
Policlinico Universitario di Messina
Caterina Musolino
Messina
Divisione di Ematologia
Azienda Ospedaliera Ospedali Riuniti "Papardo Piemonte"
Donato Mannina
Mestre
U.O. Ematologia
Azienda USLL12 Veneziana
Ospedale dell'Angelo e Ospedale civile S. Giovanni e Paolo
Renato Bassan
Milano
U.O. Ematologia 1
Centro Trapianti di Midollo
Ospedale Maggiore Milano
Alessandra Iurlo
Napoli
XIX Divisione di Ematologia con trapianto
A.O.R.N. "A. Cardarelli"
Felicetto Ferrara
Napoli
Dipartimento di Med. Clinica e Sperimentale- Area di Ematologia
Facoltà di Medicina e Chirurgia
Università degli Studi di Napoli "Federico II"
Lugia Luciano
Napoli
U.O. Ematologia
Ospedale S. Gennaro
Lucia Mastrullo
Novara
Divisione di Ematologia
Dip. Di Medicina Clinica e Sperimentale & BRMA
Università Piemonte Orientale "Amedeo Avogato"
Gianluca Gaidano
Padova
Ematologia ed Immunologia Clinica
Università degli studi di Padova
Gianni Binotto
not yet recruiting
Palermo
U.O.C. Ematologia
A.O. Ospedali Riuniti "Villa Sofia-Cervello"
Diamante Turri
Palermo
Divisione di Ematologia con trapianto di midollo
A.O.U. Policlinico "Paolo Giaccone"
Vincenzo Accurso
Parma
Ematologia e CTM
A.O.U. Università degli Studi di Parma
Monica Crugnola
Piacenza
Unità Operativa Ematologia e Centro Trapianti
Dipartimento di Oncologia ed Ematologia
AUSL Ospedale di Piacenza
Daniele Vallisa
Pisa
U.O. Ematologia
A.O.U. Pisana
Sara Galimberti
Potenza
U.O. Ematologia
A.O. San Carlo
Michele Pizzuti
Orbassano
Dipartimento di Scienze Cliniche e Biologiche
Ospedale S. Luigi Gonzaga
Giovanna Rege Cambrin
Piacenza
Unità Operativa Ematologia e Centro Trapianti
Dipartimento di Oncologia ed Ematologia
AUSL Ospedale di Piacenza
Daniele Vallisa
Reggio Calabria
Divisione di Ematologia
A.O. Ospedali Riuniti di Reggio Calabria "Bianchi-Melacrino-Morelli"
Bruno Martino
Rimini
Rimini Ospedale "Infermi"
Patrizia Tosi
Rionero in Vulture
Department of Onco-Hematology
IRCCS; Centro di Riferimento Oncologico della Basilicata
Giuseppe Pietrantuono
Roma
Divisione di Ematologia
Ospedale S.Eugenio
Elisabetta Abruzzese
Roma
U.O.C. Ematologia e Trapianto cellule staminali - Pad Cesalpino
A.O. San Camillo Forlanini
Leonardo Pacilli
Roma
U.O. di Ematologia
Ente Ospedaliero San Giovanni Addolorata
Michele Cedrone
not yet recruiting
Roma
Ematologia Policlinico
Università degli Studi di Roma Tor Vergata (PTV)
Sergio Amadori
not yet recruiting
Roma
Ematologia
A.O. Sant'Andrea
Agostino Tafuri
Roma
Clinica di Ematologia - Policlinico Umberto I
Università degli Studi "Sapienza"
Massimo Breccia
San Giovanni Rotondo
U.O. di Ematologia
Casa Sollievo della Sofferenza
Nicola Cascavilla
Sassari
Ematologia
AOU Sassari
Claudio Fozza
Taranto
U.O.C. Ematologia
A.O. SS Annunziata - P.O.S.G. Moscati
Alessandro Maggi
Terni
S.C. di Oncoematologia
A.O. "S. Maria"
Anna Maria Liberati
Torino
S.C.D.O. Ematologia II
A.O.U.S. San Giovanni Battista di Torino (Molinette)
Patrizia Pregno
Udine
Clinica Ematologica ed Unità di Terapie Cellulari Carlo Melzi
A.O. Universitaria
Mario Tiribelli
Vercelli
Onco-Ematologia - Ospedale S. Andrea
Alberto Santagostino
not yet recruiting
Verona
U.O di Ematologia d. U.
Azienda Ospedaliera Universitaria Integrata Verona
Massimo Bonifacio
Spain
Madrid
Department of Hematology
Hospital Universitario de la Princesa
Department of Hematology
Juan Luís Steegman
not yet recruiting
DIALOG (CAMN107A2203) = Study of the Efficacy and Safety of Oral Nilotinib in CML in Children and Adolescents
Study title
CAMN107A2203 = Open Label, Phase II Study to Evaluate Efficacy and Safety of Oral Nilotinib in Philadelphia Positive (Ph+) Chronic Myelogenous Leukemia (CML) Pediatric Patients [Asia, Europe, North America]
Scientific title
A multi-center, open label, non-controlled phase II study to evaluate efficacy and safety of oral nilotinib in pediatric patients with newly diagnosed Ph+ chronic myelogenous leukemia (CML) in chronic phase (CP) or with Ph+ CML in CP or accelerated phase (AP) resistant or intolerant to either imatinib or dasatinib (EudraCT-Nummer 2013-000200-41; ClinicalTrials.gov NCT01844765)
Indication and most important inclusion criteria
Children and adolescents between age 1 and 18 can be considered for inclusion in this study if they have newly diagnosed and untreated Philadelphia-positive Chronic Myelogenous Leukemia (Ph+ CML) in chronic phase or Ph+ CML in chronic or accelerated phase and do not respond to or do not tolerate imatinib or dasatinib.
Patients must achieve at least 50 percent on the Karnofsky or Lansky scale. They must also have adequately working kidneys, liver and pancreas.
Short description of intervention
This study evaluates the safety, efficacy and concentration of nilotinib over time in in children and adolescents with Philadelphia-positive chronic myelogenous leukemia.
Nilotinib will be administered at 230mg/m2, twice daily for up to 66 cycles (1 cycle = 28 days). Drug will be supplied in 50mg, 150mg,and 200mg capsules. Dose administration will be rounded to the nearest 50mg dose (to a maximum dose of 400mg).
Type of study
Pediatric trial = Trial in children and adolescents
Current status
No longer recruiting
Study sponsor
Novartis Pharma
Scientific lead / contact
Sabine Hertle
Clinical Trial Head, Novartis
Principal investigator
...
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
Canada
Hospital St. Justine
Quebec, H3T IC5
France
Groupe Hospitalier Pellegrin - Hôpital des Enfants
Bordeaux, Aquitaine, 33076
Hopital Jeanne de Flandre
Lille, 59037
Hopital Robert Debre
Paris, 75019
CHU Hopital Jean Bernard
Poitiers Cedex, 86021
Hungary
SE II.sz. Gyermekklinika
Budapest, 1094
Italy
I.R.C.C.S. Istituto Giannina Gaslini
Genova, 16147
Azienda Ospedaliera di Padova Università degli Studi
Padova, 35128
AO Città della Salute e Scienza-PO Infant. Regina Margherita
Torino, 10126
Japan
Kyoto University Hospital
Kyoto-city, Kyoto, 606-8507
Keio University Hospital
Shinjuku-ku, Tokyo, 160-8582
Saitama Children's Medical Center
Saitama, 339-8551
Shizuoka Children's Hospital
Shizuoka, 420-8660
Kanagawa Children's Medical Centre
Yokohama, Kanagawa, 232-8555
Korea, Republic of
Samsung Medical Center
Seoul, 110-744
Seoul National University Hospital
Seoul, 137-710
Malaysia
Hospital Kuala Lumpur
Netherlands
Erasmus MC
Rotterdam, 3015 CE
Russia
Center of Children's Hematology n.a. D. Rogachev
Moskow, 117198
Spain
Hospital Niño Jesus
Madrid, 28009
Thailand
Chulalongkorn Hospital
Bangkok, 10330
Siriraj Hospital
Bangkok, 10700
Maharaj Nakhon Chiangmai Hospital
Muang, Chiangmai, 50200
Turkey
Istanbul University Istanbul Medical Faculty
Istanbul, 34093
United Kingdom
Bristol Royal Hospital for Children
Bath, BS2 8BJ
Royal Marsden Hospital
Sutton, SM2 5PT
United States
California
City of Hope National Medical Center
Duarte, CA 91010-3000
Loma Linda University Health
Loma Linda, CA 92350
Miller Children's Hospital
Long Beach, CA 90806
Kaiser Permanente - California Southern
Los Angeles, CA 90027
Children's Hospital Los Angeles
Los Angeles, CA 90027
Children's Hospital Central California
Madera, CA 93636
Lucile Salter Packard Children's Hospital at Stanford
Palo Alto, CA 94304
Florida
Lee Memorial Health System
Fort Myers, FL 33908
University of Florida
Gainesville, FL 32610
Nemours Children's Hospital
Orlando, FL 32827
All Children's Hospital
St. Petersburg, FL 33701
St. Mary's Hospital
West Palm Beach, FL 33407
Georgia
Memorial Health University Medical Center
Savannah, GA 31404
Illinois
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, IL 60611
University of Chicago
Chicago, IL 60638
Indiana
Riley Hospital for Children
Indianapolis, IN 46142
Maryland
Johns Hopkins Oncology Center
Baltimore, MD 21218
Minnessota
University of Minnesota Medical Center, Fairview
Minneapolis, MN 55455
Mississippi
University of Mississippi Medical Center
Jackson, MS 39216-4505
New Jersey
UMDNJ-Robert Wood Johnson Medical Center
New Brunswick, NJ 08901
St. Joseph's Childrens Hospital
Paterson, NJ 07503
North Carolina
UNC Chapel Hill
Chapel Hill, NC 08901
Carolinas Medical Center
Charlotte, NC 28203
OhioCincinnati Children's Hospital Medical Center
Cincinnati, OH 45229-3039
Rainbow Babies & Children's Hospital
Cleveland, OH 44106-6010
Nationwide Children's Hospital
Columbus, OH 43205
Tennessee
East Tennessee Children's Hospital
Knoxville, TN 37931
St. Jude's Children's Research Hospital
Memphis, TN 38105
Texas
Dell Children's Medical Center of Central Texas
Austin, TX 78723
Children's Medical Center of Dallas
Dallas, TX 75235
Cook Children's Medical Center
Fort Worth, TX 78723
Utah
Primary Children's Medical Center
Salt Lake City, UT 84113
Virginia
Children's Hospital of the King's Daughters
Norfolk, VA 23507
Washington
Seattle Children's Hospital
Seattle, Washington, WA 98105
Wisconsin
Midwest Children's Cancer Center
Milwaukee, WI 53226
CA180-373 = A Phase 1B Study with Dasatinib plus Nivolumab in CML
Study title
A Phase 1B Study to Investigate the Safety and Preliminary Efficacy for the Combination of Dasatinib Plus Nivolumab in Patients With Chronic Myeloid Leukemia [Australia, Europe, North America]
Scientific title
A Phase 1B Dose Escalation Study to Investigate the Safety, Tolerability and Preliminary Efficacy for the Combination of Dasatinib (BMS-354825) plus Nivolumab (BMS-936558) in Patients with Chronic Myeloid Leukemia (CML) (EudraCT 2013-002156-33, ClinicalTrials.gov NCT 02011945)
Indication and most important inclusion criteria
Adult CML patients in chronic or accelerated phase and with documented Ph+ who were previously treated with two or more TKIs for CML and are currently progressing, resistant to or with a suboptimal response to their most recent therapy. Potential study participants have an Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) Score of 0–1.
Short description of intervention
The purpose of this study is to find a dose of nivolumab that can be safely added to dasatinib in patients with Chronic Myeloid Leukemia.
Dasatinib [100 mg Chronic Phase (CP)] OR 140 mg Accelerated Phase (AP)] will be given as a tablet once daily for up to 2 years in combination with nivolumab which will be given as an intravenous injection every 2 weeks for up to 2 years. The dose of nivolumab will be increased on the basis of safety determinations. Administration of dasatinib will be continued for up to 1 year after the last dose of nivolumab.
Type of study
Other trials
Current status
No longer recruiting patients
Study sponsor
Bristol-Myers Squibb
Scientific lead / contact
Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email: Clinical.Trials@bms.com
Contact: First line of the email MUST contain NCT02011945 and Site #.
Principal investigator
See site contact information
Additional information
Study description in the US register ClinicalTrials.gov, a service of the U. S. National Institutes of Health.
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.
Study centers / principal investigators
Australia
New South Wales
Local Institution
St Leonards, New South Wales, 2065
Contact: Site 0021
South Australia
Local Institution
Adelaide, South Australia, 5000
Contact: Site 0006
Victoria
Local Institution
Parkville, Victoria, 3050
Contact: Site 0004
Canada
Nova Scotia
Qeii Health Sciences Centre-Vg Site
Halifax, Nova Scotia, B3H 2Y9
Contact: Site 0019
Ontario
Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2M9
Contact: Site 0007
Quebec
Hopital Maisonneuve-Rosemont
Montreal, Quebec, H1T 2M4
Contact: Site 0022
Finland
Local Institution
Helsinki, 00029
Contact: Site 0001
Local Institution
Huch, 00029
Contact: Site 0023
Germany
Campus Virchow Klinikum Charité
13353 Berlin
Contact: Site 0027
Universitaetsklinikum Bonn,
53127 Bonn
Contact: Site 0016
Universitaetsklinkum Carl Gustav Carus
01307 Dresden
Contact: Site 0028
Universitaetsklinikum Frankfurt
60590 Frankfurt
Contact: Site 0015
Italy
Local Institution
Napoli, 80131
Contact: Site 0017
Local Institution
Orbassano, 10043
Contact: Site 0002
Local Institution
Roma, 00161
Contact: Site 0003
Spain
Local Institution
Madrid, 28047
Contact: Site 0012
Local Institution
Valencia, 46010
Contact: Site 0014
United States
Georgia
Winship Cancer Institute
Atlanta, Georgia, 30322
Contact: Site 0008
New York
Local Institution
Buffalo, New York, 14263
Contact: Site 0031
Ohio
Local Institution
Cleveland, Ohio, 44195
Contact: Site 0030
Texas
UT Southwestern Medical Center
Dallas, Texas, 75390
Contact: Site 0010
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
Contact: Site 0024
Wisconsin
Froedert Hospital & Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Contact: Site 0029