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

Overview

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. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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 the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Aref Al-Kali, M.D.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20115571

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