An Open-label, Randomized Study of Dasatinib vs High-dose (800-mg) Imatinib in the Treatment of Subjects With Chronic Phase Chronic Myeloid Leukemia Who Have Had a Suboptimal Response After at Least 3 Months of Therapy With 400 mg Imatinib
18 Years
N/A
Both
Leukemia, Myeloid, Chronic
Trial Information
An Open-label, Randomized Study of Dasatinib vs High-dose (800-mg) Imatinib in the Treatment of Subjects With Chronic Phase Chronic Myeloid Leukemia Who Have Had a Suboptimal Response After at Least 3 Months of Therapy With 400 mg Imatinib
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failures and withdrawn from the study.
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Percentage of Participants With Chronic Phase Chronic Myeloid Leukemia Who Have a Major Molecular Response (MMolR)
Outcome Description:
MMolR is defined as reduction in transcript levels of the breakpoint cluster region (BCR)-V-abl Abelson murine leukemia viral oncogene homolog 1 (ABL) gene of at least 3 log. The BCR-ABL gene has a role in the production of a mutated protein that converts bone marrow stem cells from normal to leukemic.
Outcome Time Frame:
At 12 months from baseline
Safety Issue:
No
Principal Investigator
Bristol-Myers Squibb
Investigator Role:
Study Director
Investigator Affiliation:
Bristol-Myers Squibb
Authority:
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study ID:
CA180-043
NCT ID:
NCT00320190
Start Date:
August 2006
Completion Date:
January 2010
Related Keywords:
- Leukemia, Myeloid, Chronic
- Chronic phase CML, with a suboptimal response after treatment with imatinib
- Leukemia
- Leukemia, Myeloid
- Leukemia, Myelogenous, Chronic, BCR-ABL Positive
- Leukemia, Myeloid, Chronic-Phase
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