DASFREE (CA180-406) = Discontinuation of dasatinib in CP-CML patients with stable MR4.5
Study title
Scientific title
Open-Label Single Arm Phase 2 Study Evaluating Dasatinib Therapy Discontinuation in Patients With Chronic Phase Chronic Myeloid Leukemia (CP-CML) With Stable Complete Molecular Response (CMR) DASFREE
(EudraCT No. 2012-001421-27 / Clinicaltrials.gov No. NCT01850004)
Type of study
Treatment discontinuation trials
Current status
No longer recruiting
What is the purpose of the study
The study tests whether patients with CML in chronic phase and with stable CMR who discontinue Dasatinib treatment are able to maintain a sustained remission in the long-term (= 12 months after Dasatinib discontinuation without restarting Dasatinib), with undetectable or minimally detectable BCR-ABL residual disease.
Key inclusion criteria
Men and women diagnosed with CML in chronic phase, who have been treated with Dasatinib for at least 2 years at the time of enrollment and who are in Dasatinib-induced complete molecular remission for at least 1 year before study entry
Patients are eligible for the screening assessment from the central lab if they have been in stable dasatinib induced CMR for at least one year, documented by at least three assessments, conducted 2.5 – 6.5 months apart, at a local lab. The first screening assessment conducted at the central lab will be repeated after three months, if the first assessment confirms CMR (MR 4.5). Patients are eligible for enrollment if both assessments from the central lab confirm ≤ 0.0032% International Scale (IS) or MR4.5.
Patients with CML in chronic phase treated with Dasatinib as first line treatment or patients with CML in chronic phase receiving Dasatinib in second line after treatment with a tyrosine-kinase inhibitor (TKI)
Patients with a life expectancy of more than 1 year.
Key exclusion criteria
Where can I find additional information
Study description in 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 sponsor
Bristol-Myers Squibb
Scientific lead / contact
Bristol-Myers Squibb
Principal investigator
See site contact information
Study centers / principal investigators
Canada
Local Insitution
Toronto, Ontario, Canada, M5G 2M9
France
Local Institution
Paris Cedex 10, 75475
Local Institution
Pessac, 33604
Local Institution
Pierre Benite, 69310
Local Institution
Vandoeuvre les Nancy, 54511
Germany
Aachen
Universitätsklinikum Aachen
Berlin
Local Institution
13353 Berlin
Mannheim
Medizinische Fakultät Mannheim der
der Ruprecht-Karls-Universität Heidelberg
III. Medizinische Klinik
Rostock
Local Institution
18055 Rostock
Ulm
Local Institution
89081 Ulm
Italy
Local Institution
Catania, 95124
Local Institution
Firenze, 50134
Local Institution
Napoli, 80131
Local Institution
Orbassano, 10043
Local Institution
Roma, 00144
Local Institution
Roma, 00161
Spain
Local Institution
Las Palmas de Gran Canaria, Spain, 35010
Local Institution
Madrid, 28034
Local Institution
Malaga, 29010
Local Institution
Oviedo, 33011
United States
California
City of Hope Medical Center
Duarte, California, 91010
David Geffen School of Medicine at Ucla
Los Angeles, 90095
Ucsf Division Of Hematology And Oncology
San Francisco, California, 94143
New Jersey
John Theurer Cancer Center At Hackensack University Medical Center
Hackensack, New Jersey, 07601
New York
Columbia University Medical Center (Cumc)
New York, New York, 10032
Texas
Baylor Charles A. Sammons Cancer Center
Dallas, Texas, 75246