Gleevec (Imatinib) Plus Multi-Agent Chemotherapy For Newly-Diagnosed Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Asan Medical Center
- Enrollment
- 50
- Locations
- 2
- Primary Endpoint
- Proportion of patients achieving hematologic and molecular complete response (CR) after induction chemotherapy and imatinib mesylate
Study Overview
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 mesylate may also stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. It is not yet known which treatment regimen is most effective in treating acute lymphoblastic leukemia.
PURPOSE: This phase II trial is studying the side effects of giving imatinib mesylate together with combination chemotherapy with or without a donor stem cell transplant and to see how well it works in treating patients with newly diagnosed acute lymphoblastic leukemia.
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 overall survival in patients with newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia.
- To determine the toxicities of this regimen in these patients.
Secondary
- To establish the prognostic factors in patients treated with this regimen.
Study Design
- Study Type
- Interventional
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 15 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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 Criteria
- Not provided
Outcomes
Primary Outcomes
Proportion of patients achieving hematologic and molecular complete response (CR) after induction chemotherapy and imatinib mesylate
Duration of hematologic CR
Durations of hematologic and molecular CR after hematopoietic stem cell transplantation
Secondary Outcomes
- Overall survival
- Clinical toxicities
- Prognostic factors in patients treated with this regimen