Conditions: Leukemia
Allocation: NON_RANDOMIZED | Intervention model: PARALLEL
Enrollment: 238
Healthy volunteers: no

Brief summary:
This study assesses the long-term safety and tolerability of dasatinib administered to patients with chronic myelogenous leukemia or Philadelphia chromosome positive acute lymphoblastic leukemia and experienced clinical benefit from treatment with dasatinib or imatinib in previous protocols.

Detailed description:

Arms:
arm 1: Participants with chronic phase disease continued on the previous study dose of dasatinib, ranging from 50 mg once daily (QD) to 120 mg twice daily (BID). arm 2: Participants with chronic phase disease received 400 mg of imatinib twice BID. arm 3: Participants with advanced phase disease, accelerated phase (AP), continued on the previous study dose of dasatinib, ranging from 50 mg QD to 120 mg BID. arm 4: Participants with advanced phase disease, myeloid blast cell (MBP), continued on the previous study dose of dasatinib, ranging from 50 mg QD to 120 mg BID. arm 5: Participants with advanced phase disease, Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL), continued on the previous study dose of dasatinib, ranging from 50 mg QD to 120 mg BID.

Interventions: intervention 1: Dasatinib intervention 2: Imatinib
Intervention descriptions: intervention 1: Dasatinib was supplied as 20- and 50-mg tablets. intervention 2: Imatinib was supplied as 100- and 400-mg tablets.

Protocol document: