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

GIMEMA Foundation

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

Subcategories

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