Study of Dasatinib in Patients With Chronic Phase Chronic Myeloid Leukemia and a Suboptimal Response to Imatinib

Bristol-Myers Squibb (BMS)

Status and phase: Terminated; Phase 2

Conditions: Leukemia, Myeloid, Chronic

Treatments: Drug: Imatinib; Drug: Dasatinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT00320190

CA180-043

EUDRACT Number: 2005-005153-22

Details and patient eligibility

About

The purpose of this study is to compare the efficacy of dasatinib with that of high-dose (800-mg) imatinib in participants with chronic phase chronic myeloid leukemia who achieved only a suboptimal response after at least 3 months of monotherapy with 400-mg imatinib. The safety of these treatments will also be evaluated.

Full description

Participants were randomized 2:1 to dasatinib or high-dose imatinib, respectively. Randomization was stratified by a suboptimal response, defined as a hematologic response less than a complete hematologic response after at least 3 months of monotherapy with 400-mg imatinib; a cytogenic response (CgR) less than a partial CgR (PCgR) after at least 6 months of monotherapy with 400-mg; a PCgR after at least 12 months of monotherapy with 400-mg imatinib; or less than a major molecular response with a complete CgR after at least 18 months of monotherapy with 400-mg imatinib.

Participants received either dasatinib or imatinib for 12 months or until disease progression, unacceptable toxicity, consent withdrawal, or study discontinuation. After 12 months, who had a confirmed major molecular response and were still receiving dasatinib, 100 mg, or imatinib, 800 mg, were eligible to extend treatment for an additional 12 months. Participants permanently discontinuing treatment before 12 months were considered treatment failures and withdrawn from the study.

Enrollment: 52 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Chronic phase Ph^+ chronic myeloid leukemia (CML) demonstrating only a suboptimal response, defined as a hematologic response that is less than a complete hematologic response after at least 3 months of monotherapy with imatinib, 400 mg; a cytogenic response (CgR) that is less than a partial CgR (PCgR) after at least 6 months of monotherapy with imatinib, 400 mg; a PCgR after at least 12 months of monotherapy with imatinib, 400 mg; or less than a major molecular response with a complete CgR after at least 18 months of monotherapy with imatinib, 400 mg.
• Either gender
• Age of 18 years or older

Exclusion criteria

• Previous diagnosis of accelerated phase or blast crisis CML
• Uncontrolled or significant cardiovascular disease
• History of significant bleeding disorder unrelated to CML
• Concurrent malignancies
• Intolerance of imatinib, 400 mg
• Prior treatment with imatinib at a dose higher than 400 mg
• Prior stem cell transplantation and/or high-dose chemotherapy for CML

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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52 participants in 2 patient groups

Dasatinib

Active Comparator group

Description:

Participants with chronic phase chronic myeloid leukemia (CML) who had only a suboptimal response after at least 3 months of therapy with imatinib, 400 mg.

Treatment:

Drug: Dasatinib

Imatinib

Active Comparator group

Description:

Participants with chronic phase CML who had only a suboptimal response after at least 3 months of therapy with imatinib, 400 mg.

Treatment:

Drug: Imatinib