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Clinical Trials/NCT00812669
NCT00812669CompletedPhase 2

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

Cancer Trials Ireland7 sites in 1 country52 target enrollmentStarted: August 18, 2008Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Phase 2
Status
Completed
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

Experimental

Intervention: pegfilgrastim (Biological)

Fludarabine, Cylophosphamide and Rituximab

Experimental

Intervention: rituximab (Biological)

Fludarabine, Cylophosphamide and Rituximab

Experimental

Intervention: cyclophosphamide (Drug)

Fludarabine, Cylophosphamide and Rituximab

Experimental

Intervention: fludarabine phosphate (Drug)

Fludarabine, Cylophosphamide and Rituximab

Experimental

Intervention: cytogenetic analysis (Genetic)

Fludarabine, Cylophosphamide and Rituximab

Experimental

Intervention: fluorescence in situ hybridization (Genetic)

Fludarabine, Cylophosphamide and Rituximab

Experimental

Intervention: gene expression analysis (Genetic)

Fludarabine, Cylophosphamide and Rituximab

Experimental

Intervention: mutation analysis (Genetic)

Fludarabine, Cylophosphamide and Rituximab

Experimental

Intervention: protein expression analysis (Genetic)

Fludarabine, Cylophosphamide and Rituximab

Experimental

Intervention: flow cytometry (Other)

Fludarabine, Cylophosphamide and Rituximab

Experimental

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)

Investigators

Sponsor Class
Network
Responsible Party
Sponsor

Study Sites (7)

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