The study purpose is to test the hypothesis that patients with Chronic phase-Chronic Myeloid Leukemia (CP-CML) with BCR-ABL transcript level > 10% International Standard (IS) after 3 months of treatment with first line Imatinib 400mg will achieve a greater rate of major molecular response (MMR) by early switching to Dasatinib therapy 100mg once daily (QD) compared with continued treatment with Imatinib at any dose.
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
Last updated: 11/22/2012
NCT ID: NCT01593254
IRB Number:12-006064
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