NCT01005758UnknownPhase 2
DFCI ALL Adult Consortium Protocol: Adult ALL Trial
Ohio State University Comprehensive Cancer Center0 sites180 target enrollmentStarted: January 2009Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Enrollment
- 180
- Primary Endpoint
- Feasibility of intensification therapy, measured as the percentage of patients who, having achieved a complete remission after induction therapy, receive > 25 weeks of pegaspargase IV as part of intensification therapy
Study Overview
Brief Summary
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells.
PURPOSE: This phase II trial is studying the side effects of combination chemotherapy and to see how well it works in treating adult patients with newly diagnosed acute lymphoblastic leukemia.
Detailed Description
OBJECTIVES:
Primary
- To determine the feasibility, toxicity, and efficacy of a high-risk pediatric treatment regimen in adult patients with newly diagnosed acute lymphoblastic leukemia (ALL).
- To explore the relative toxicity of pegaspargase IV.
- To explore the relative efficacy and toxicity of adding imatinib mesylate to multi-agent chemotherapy for patients with Philadelphia chromosome-positive ALL.
Secondary
- To estimate the complete remission (CR) rate at the end of induction therapy and calculate the corresponding 90% confidence interval (CI).
- To estimate the disease-free survival (DFS), defined as the time from achieving a CR to the first disease recurrence or death, of a subset of patients who achieve a CR at the end of induction therapy.
- To estimate the overall survival (OS), defined as the time from study entry to death from any cause, of all patients.
- To calculate the median, 2-year, and 3-year DFS and OS rates and their corresponding 95% CI's.
- To evaluate the prognostic significance of the prednisone prophase response, minimal residual disease at various time points, the frequency and type of tyrosine kinase mutations, and gene expression profiles at diagnosis.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 50 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Feasibility of intensification therapy, measured as the percentage of patients who, having achieved a complete remission after induction therapy, receive > 25 weeks of pegaspargase IV as part of intensification therapy
Toxicity
Secondary Outcomes
- Complete remission rate
- Disease-free and overall survival
- Prognostic significance of prednisone prophase response, minimal residual disease at various time points, tyrosine kinase mutations, and gene expression profiles at diagnosis
Investigators
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