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

Location:

Rochester, Minn.

Trial status:

Open for Enrollment

Why is this study being done?

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.

Who is eligible to participate?

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com. 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 6 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/A, F317L, or V299L mutations - Prior Chronic Myeloid Leukemia (CML) treatment other than Imatinib - Serious, uncontrolled Medical condition

Last updated:

8/8/2014

NCT ID:

NCT01593254

IRB Number:

12-006064