Status:
AVAILABLE
The Randomized Study of Dasatinib and High-Dose Imatinib (600mg) in Suboptimal Responder
Lead Sponsor:
Pusan National University Hospital
Conditions:
Chronic Myeloid Leukemia
Eligibility:
All Genders
18+ years
Brief Summary
Research Hypothesis: Treatment with dasatinib 100 mg QD is superior to imatinib 600 mg QD in terms of complete cytogenetic response (CCyR) in chronic phase (CP) Philadelphia chromosome-positive (Ph+)...
Detailed Description
Study Design: Prospective open-label, randomized two arms, multicenter study for the patients with suboptimal response to standard Tx to evaluate efficacy \& safety of dasatinib (100mg qd) \& imatinib...
Eligibility Criteria
Inclusion
- Signed written informed consent, at least 18 years old
- Adequate hepatic renal function
- Dasatinib naïve patients
- Patients with cytogenetically and/or molecularly confirmed Philadelphia chromosome or BCR-ABL positive CP-CML who have been treated with standard dose of imatinib.
- ECOG status: 0-2
- And one of following criteria for imatinib suboptimal response 1)CP-CML patients who have failed to achieve a CHR at 3 months or MCyR at 6 months of therapy with imatinib 400mg daily. 2)CP-CML patients who have failed to achieve a CCyR at 12 months with imatinib 400mg daily 3)CP-CML patients who have failed to achieve a MMoR (less than 3 log reduction) at 18 months with imatinib 400mg daily 4)CP-CML patients who have lost molecular response by an increase of BCR-ABL more than 10 times regardless treatment duration.
Exclusion
- Concurrent malignancy
- Patients who have received SCT
- Allergy or hypersensitivity reaction to the study drugs
- Female who are pregnant or breast feeding.
- T315I mutation
- History of significant bleeding disorder
- Women of child bearing potential
- Uncontrolled or significant CVS disease: IHD. CHF
- Prior imatinib\>400mg, imatinib\>18 months
- Intolerance to imatinib 400mg
Key Trial Info
Start Date :
Trial Type :
EXPANDED_ACCESS
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00854841
Last Update
March 3 2009
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