DASAPOST

SPAIN: Multicenter, Open-label, Non-randomized Phase II Trial of Dasatinib in Patients With Chronic Myeloid Leukemia in Chronic Phase (CP-CML) Who Meet Criteria for Late Suboptimal Response After Prior Imatinib Treatment.

This study is currently recruiting participants

Estimated Enrollment ICMJE: 65

Verified April 2015 by PETHEMA Foundation

Sponsor: PETHEMA Foundation

Information provided by (Responsible Party): PETHEMA Foundation

Collaborators

• Dynamic Solutions
• Bristol-Myers Squibb

This is a single-arm, open-label, phase II trial for patients in complete cytogenetic response that have not achieved major molecular response or have lost a prior major molecular response, after at least 18 months of treatment with imatinib. All enrolled patients will receive dasatinib 100 mg once daily orally for 1 year until progression, loss of cytogenetic response, transformation to advanced phases, unacceptable toxicity (clinical adverse event, lab abnormality or concurrent disease), pregnancy if a female or withdrawal of consent, whichever happens first.