An Open-label Phase II Study of the Efficacy and Safety of the Combination of Fludarabine, Cyclophosphamide and Rituximab in Patients With Chronic Lymphocytic Leukaemia Who Are Newly Diagnosed, Have Relapsed or Are Resistant to First-Line Treatment
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Cancer Trials Ireland
- Enrollment
- 52
- Locations
- 7
- Primary Endpoint
- Complete remission rate by NCI response criteria and minimal residual disease (MRD) analysis
Study Overview
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as fludarabine and cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Giving fludarabine together with cyclophosphamide and rituximab may kill more cancer cells.
PURPOSE: This phase II trial is studying giving fludarabine together with cyclophosphamide and rituximab to see how well it works in treating patients with chronic lymphocytic leukemia.
Detailed Description
OBJECTIVES:
Primary
- Evaluate the efficacy, in terms of complete remission rate, of fludarabine phosphate, cyclophosphamide, and rituximab in patients with chronic lymphocytic leukemia.
Secondary
- Determine the time to treatment failure (TTF) in these patients.
- Determine the overall survival of these patients until 10th January 2019.
- Assess the predictive value of immunophenotype, hypermutation analysis, and FISH in determining TTF and OS in these patients.
- Determine the safety profile of this regimen.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 0 Years to 64 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Fludarabine, Cylophosphamide and Rituximab
Intervention: pegfilgrastim (Biological)
Fludarabine, Cylophosphamide and Rituximab
Intervention: rituximab (Biological)
Fludarabine, Cylophosphamide and Rituximab
Intervention: cyclophosphamide (Drug)
Fludarabine, Cylophosphamide and Rituximab
Intervention: fludarabine phosphate (Drug)
Fludarabine, Cylophosphamide and Rituximab
Intervention: cytogenetic analysis (Genetic)
Fludarabine, Cylophosphamide and Rituximab
Intervention: fluorescence in situ hybridization (Genetic)
Fludarabine, Cylophosphamide and Rituximab
Intervention: gene expression analysis (Genetic)
Fludarabine, Cylophosphamide and Rituximab
Intervention: mutation analysis (Genetic)
Fludarabine, Cylophosphamide and Rituximab
Intervention: protein expression analysis (Genetic)
Fludarabine, Cylophosphamide and Rituximab
Intervention: flow cytometry (Other)
Fludarabine, Cylophosphamide and Rituximab
Intervention: laboratory biomarker analysis (Other)
Outcomes
Primary Outcomes
Complete remission rate by NCI response criteria and minimal residual disease (MRD) analysis
Time Frame: A formal assessment of response by NCI Criteria (Appendix 3) with the addition of assessment of minimal residual disease in the marrow and if relevant assessment of bulky disease by CT scanning will be made after 4 +/-6 courses of therapy.
Secondary Outcomes
- Overall survival(Until 10th January 2019)
- Time to treatment failure (TFF)(A clinical assessment of response will be made after 4 courses of therapy, Patients with evidence of progressive disease will stop therapy and will be deemed to have failed treatment.)
- Acute and chronic toxicity as assessed by NCI criteria(A formal assessment of response by NCI Criteria (Appendix 3) with the addition of assessment of minimal residual disease in the marrow and if relevant assessment of bulky disease by CT scanning will be made after 4 +/-6 courses of therapy.)
- Predictive value of immunophenotype, FISH, and hypermutation analysis in determining TTF and OS(See description)