Study Comparing Dasatinib and High-Dose Imatinib for Patients with Suboptimal Response in Chronic Myeloid Leukemia

Sponsor: Pusan National University Hospital

Expanded Access
Sponsor score: 60
Inactive

ClinicalTrials ID:NCT00854841

Provider View

This clinical trial is testing whether dasatinib is more effective than a higher dose of imatinib in patients with chronic myeloid leukemia (CML) who have not responded well to standard imatinib treatment.

Patient Parameters

Program Overview

The study aims to find out if dasatinib, taken once daily, is better than a higher dose of imatinib in achieving a complete response in patients with chronic phase Philadelphia chromosome-positive chronic myeloid leukemia (CML) who have not responded well to standard imatinib treatment. The main goal is to compare the effectiveness of dasatinib to high-dose imatinib in achieving a complete cytogenetic response (CCyR) after six months of treatment.

Description

This study involves patients with chronic myeloid leukemia (CML) who have not responded well to standard treatment with imatinib. Participants will be randomly assigned to receive either dasatinib or a higher dose of imatinib. The study will last up to 12 months, unless the disease worsens or side effects become unacceptable. Participants will be monitored for their response to the treatment and any side effects. The study will include 90 participants, and they will be randomly assigned to one of the two treatment groups. Participants in the dasatinib group will start with a dose of 100 mg per day, with possible adjustments based on side effects. Participants in the imatinib group will start with a dose of 600 mg per day, with possible increases if the response is inadequate. The study will evaluate the effectiveness of the treatments by measuring the complete cytogenetic response (CCyR) at six months, as well as other response rates and progression-free survival. Safety will be monitored by reporting any adverse effects experienced by participants.

Eligibility Criteria

Inclusion Criteria

  • Must be at least 18 years old and have signed a consent form.
  • Have adequate liver and kidney function.
  • Have not previously taken dasatinib.
  • Have chronic phase Philadelphia chromosome-positive CML confirmed by tests.
  • Have been treated with standard dose imatinib but have not responded well.
  • Have an ECOG performance status of 0 to 2.
  • Meet specific criteria for suboptimal response to imatinib, such as not achieving certain response levels at specific time points.

Exclusion Criteria

  • Have another type of cancer at the same time.
  • Have had a stem cell transplant.
  • Have allergies to the study drugs.
  • Are pregnant or breastfeeding.
  • Have a specific genetic mutation (T315I).
  • Have a history of significant bleeding disorders.
  • Are a woman of childbearing potential.
  • Have uncontrolled or significant heart disease.
  • Have taken imatinib at doses higher than 400 mg or for more than 18 months.
  • Cannot tolerate imatinib at 400 mg.

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