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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
Description
Phase
N/A
Inclusion and Exclusion 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
- 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
Sites
-
California
- Usc/Norris Comprehensive Cancer Center, Los Angeles, California, 90033
- Southern California Permanente Medical Group, BellFlower, California, 90706
- Innovative Clinical Research Institute, Whittier, California, 90603
- Pacific Cancer Medical Center Inc, Anaheim, California, 92801
- Kaiser Permanente Medical Center, Vallejo, California, 94589
-
Texas
- Institute Of Oncology Hematology Biomedical Research Llc, Laredo, Texas, 78041
- Michael E Debakey Va Medical Center, Houston, Texas, 77030
-
Minnesota
- Mayo Clinic, Rochester, Minnesota, 55905
-
Iowa
- University Of Iowa Hospitals And Clinics, Iowa City, Iowa, 52242
-
Illinois
- Carle Cancer Center, Urbana, Illinois, 61801
- Northwestern University Feinberg School Of Medicine, Chicago, Illinois, 60611
-
Wisconsin
- Froedtert-Medical College Of Wisconsin, Milwaukee, Wisconsin, 53226
-
Tennessee
- Sarah Cannon Res Inst, Nashville, Tennessee, 37203
-
Indiana
- Michiana Hematology Oncology, P.C., Westville, Indiana, 46391
- St. Francis Medical Group Oncology And Hematology Specialist, Indianapolis, Indiana, 46237
-
Ohio
- Oncology Hematology Care, Incorporated, Cincinnati, Ohio, 45242
-
Italy
- Local Institution, Catania, 95124
- Local Institution, Napoli, 80131
- Local Institution, Firenze, 50134
- Local Institution, Bari, 70124
-
France
- Local Institution, Lille CEDEX, 59037
- Local Institution, Vandoeuvre les Nancy, 54511
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Czech Republic
- Local Institution, Hradec Kralove, 50005
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Spain
- Local Institution, Las Palmas de Gran Canaria, 35010
- Local Institution, Toledo, 45004