An Open Label, Randomized (2:1) Phase IIb Study of Dasatinib Versus Imatinib in Patients With Chronic Phase Chronic Myeloid Leukemia Who Have Not Achieved an Optimal Response to 3 Months of Therapy With 400 mg Imatinib
Phase 2
18 Years
N/A
18 Years
N/A
Open (Enrolling)
Both
Chronic Phase Chronic Myeloid Leukemia
Both
Chronic Phase Chronic Myeloid Leukemia
Trial Information
An Open Label, Randomized (2:1) Phase IIb Study of Dasatinib Versus Imatinib in Patients With Chronic Phase Chronic Myeloid Leukemia Who Have Not Achieved an Optimal Response to 3 Months of Therapy With 400 mg Imatinib
Inclusion Criteria:
- CP-CML Philadelphia chromosome positive (Ph+) patients with CHR but with BCR-ABL
level > 10% IS after 3 months of Imatinib 400 mg treatment. Imatinib monotherapy must
have been started within 3 months of CP-CML diagnosis
- Currently tolerating Imatinib 400 mg QD
- Eastern Co-Operative Group (ECOG) performance status = 0 - 2
- Adequate renal function defined as serum creatinine ≤ 3 times the institutional upper
limit of normal (ULN)
- Adequate hepatic function defined as:
- Total Bilirubin ≤ 2.0 times institutional ULN
- Alanine Aminotransferase (ALT) ≤ 2.5 times the institutional ULN
- Aspartate Aminotransferase (AST) ≤ 2.5 times the institutional ULN
- Serum Na, K, Mg, and total serum Ca or ionized Ca levels must be greater than or
equal to the institutional lower limit of normal
Exclusion Criteria:
- Accelerated Phase (AP)/ blast crisis (BP) diagnosis
- Not in Complete Hematologic Response (CHR) by 3 month
- Documented T315I mutation
- Prior Chronic Myeloid Leukemia (CML) treatment other than Imatinib
- Serious, uncontrolled Medical condition
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Proportion of subjects who achieve Major Molecular Response (MMR) rate
Outcome Time Frame:
At 12 months
Safety Issue:
No
Principal Investigator
Bristol-Myers Squibb
Investigator Role:
Study Director
Investigator Affiliation:
Bristol-Myers Squibb
Authority:
United States: Food and Drug Administration
Study ID:
CA180-399
NCT ID:
NCT01593254
Start Date:
September 2012
Completion Date:
July 2019
Related Keywords:
- Chronic Phase Chronic Myeloid Leukemia
- Leukemia
- Leukemia, Myeloid
- Leukemia, Myelogenous, Chronic, BCR-ABL Positive
- Leukemia, Myeloid, Chronic-Phase
Name | Location |
|---|---|
| Tennessee Oncology, PLLC | Clarksville, Tennessee 37043 |
