CML DASATINIB v1
Research type
Research Study
Full title
PHASE II EFFICACY AND SAFETY STUDY OF DASATINIB IN PATIENTS WITH CHRONIC AND ACCELERATED PHASE CHRONIC MYELOID LEUKEMIA RELAPSING AFTER ALLOGENEIC BLOOD OR BONE MARROW TRANSPLANTATION
IRAS ID
19498
Contact name
Jane APPERLEY
Contact email
Eudract number
2008-001361-29
Clinicaltrials.gov Identifier
Research summary
This is a phase II efficacy (indicates the capacity for beneficial change or therapeutic effect) and safety study of Dasatinib in patients with relapsed Chronic Myeloid Leukemia (CML) following a Stem Cell Transplant (SCT) and who are not benefiting from other treatment, such as imatinib therapy.
A relapse is when an illness that has seemed to be getting better, or to have been cured, comes back or gets worse again.A total of 50 patients =18 years of age will be registered on the trial.
Enrolled subjects will be commenced on Dasatinib (Sprycel) 100mg once a day. The first 6 patients will be observed for dose-limiting toxicities (DLTs), which may occur during the first 4 weeks of treatment. If 2 or more subjects experience DLTs (greater than one third), then the initial dose of dasatinib will be reduced for all subsequent subjects enrolled into the trial as per the most recent Sprycel Summary of Product Characteristics (SMPC) to 80mg once a day according to dose modification.
If less than two DLTs are observed in the first six patients, all subsequent subjects will be commenced on Dasatinib 100mg once a day, administered orally, consistently either in the morning or in the evening.Patients will be followed up closely for a period of 12 months and then once a year for a further 3 years from start of treatment.
This study is being conducted in a number of institutions throughout Europe. It is sponsored by the European Group for Blood and Marrow Transplantation (EBMT) who are an academic not-for-profit research organisation.
The biopharmaceutical company Bristol-Myers Squibb are providing funding to the EBMT towards the organizational costs of the study.REC name
London - Riverside Research Ethics Committee
REC reference
09/H0706/75
Date of REC Opinion
30 Oct 2009
REC opinion
Further Information Favourable Opinion