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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

  • Czech Republic

    • Local Institution, Hradec Kralove, 50005

  • Spain

    • Local Institution, Las Palmas de Gran Canaria, 35010
    • Local Institution, Toledo, 45004
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