NCT01802450

Dasatinib in Patients With Chronic Myeloid Leukemia in Chronic Phase

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: PETHEMA Foundation · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Trial try to assess the efficacy of dasatinib in terms of major molecular response rate at 6 months in patients with CP-CML who have achieved complete cytogenetic response without major molecular response after at least 18 months on Imatinib 400/600.

Detailed description

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. Patients will undergo BCR-ABL assessments at study entry and every 3 months (central lab) and immunophenotyping and studies for clonal lymphocytosis at study entry, at 3 and 6 months. Cytogenetic assessment will be done only if loss of response/progression/clonal evolution are suspected. Subjects will be evaluated for the efficacy and safety of dasatinib (Sprycel). Lymphocytosis data will be collected for all patients and separate description for efficacy and safety parameters will be done in patients with and without lymphocytosis.

Conditions

• Chronic Myeloid Leukemia

Interventions

Type	Name	Description
DRUG	Dasatinib

Timeline

• Start date: 2013-03-01
• Primary completion: 2015-06-01
• Completion: 2016-12-01
• First posted: 2013-03-01
• Last updated: 2015-09-17

Locations

15 sites across 1 country: Spain