Phase IIb Study of Dasatinib Versus Imatinib in Patients With CML-CP Who Have Not Achieved an Early Optimal Response to Imatinib

  • Study type:

    Interventional What is this?

    Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • Study phase:

    II What is this?

    During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

Study IDs

  • Site IRB:

    • Rochester, Minnesota: 12-006064
  • NCT ID:

    NCT01593254
  • Sponsor Protocol Number:

    CA180399

About this study

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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

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

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Aref Al-Kali, M.D.

Open for enrollment

Cancer Center Clinical Trials Referral Office

855-776-0015