Status:
COMPLETED
Imatinib Mesylate and Combination Chemotherapy With or Without a Donor Stem Cell Transplant in Treating Patients With Newly Diagnosed Acute Lymphoblastic Leukemia
Lead Sponsor:
Asan Medical Center
Conditions:
Leukemia
Eligibility:
All Genders
15+ years
Phase:
PHASE2
Brief Summary
RATIONALE: Giving chemotherapy before a donor stem cell transplant helps stop the growth of cancer cells. It also helps stop the patient's immune system from rejecting the donor's stem cells. Imatinib...
Detailed Description
OBJECTIVES: Primary * To determine the clinical efficacy of imatinib mesylate and combination chemotherapy in terms of complete response (CR) rate (both hematologic and molecular), CR duration, and ...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Acute lymphoblastic leukemia (ALL) or acute mixed lineage leukemia
- Newly diagnosed disease
- Philadelphia-chromosome positive (Ph+) acute lymphoblastic leukemia or Ph+ acute mixed lineage leukemia
- Positive result for RT-PCR for Bcr-Abl transcript (Ph+ ALL or Philadelphia-chromosome positive acute mixed lineage leukemia)
- PATIENT CHARACTERISTICS:
- Bilirubin \< 2 mg/dL
- SGOT \< 3 times upper limit of normal
- Creatinine \< 2.0 mg/dL
- Ejection fraction \> 45% by MUGA scan
- Not nursing
- Fertile patients must use effective contraception
- No known sensitivity to study drugs
- No severe medical conditions that, in the view of the investigator, prohibits participation in the study
- PRIOR CONCURRENT THERAPY:
- No other investigational agents in the past 30 days
Exclusion
Key Trial Info
Start Date :
October 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2009
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00618501
Start Date
October 1 2005
End Date
January 1 2009
Last Update
March 26 2013
Active Locations (1)
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1
Asan Medical Center - University of Ulsan College of Medicine
Seoul, South Korea, 138-736