Study of Dasatinib vs Imatinib in Patients With Chronic Myeloid Leukemia (CML) Who Did Not Have Favorable Response to Imatinib

Official Title

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

Summary:

The purpose of this study is to test the hypothesis that patients with CML who have not achieved optimal response after 3 months of treatment with imatinib will have a better response by switching to dasatinib compared to staying on their original imatinib regimen.

Trial Description

Primary Outcome:

  • Proportion of subjects who achieve Major Molecular Response (MMR) rate
Secondary Outcome:
  • Time to MMR - Time to MMR is the time between randomization date and first date that MMR criteria are satisfied
  • Time to MR^4.5 - Time to MR^4.5 is the time between randomization date and first date that MR^4.5 criteria are satisfied
  • Progression Free Survival (PFS) - PFS is defined as the time from randomization date to progression date or death date, whichever occurs first.
  • Overall Survival (OS) - OS is defined as the time from randomization date to death date.

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society