DASFREE (CA180-406) = Discontinuation of dasatinib in CP-CML patients with stable MR4.5

Study title

DASFREE (CA180-406) = Open study to assess discontinuation of dasatinib treatment in CP-CML patients with stable MR4.5 [Europe, North America]

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)

Indication and most important 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.

Short description of intervention

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.

Type of study

Treatment discontinuation trials

Current status

No longer recruiting

Study sponsor

Bristol-Myers Squibb

Scientific lead / contact

Bristol-Myers Squibb

Principal investigator

See site contact information

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 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