NCT00337246

Combination Chemotherapy With or Without Rituximab in Treating Patients With Previously Treated Chronic Lymphocytic Leukemia

A Randomized Phase II Trial of Fludarabine, Cyclophosphamide and Mitoxantrone (FCM) With or Without Rituximab in Previously Treated Chronic Lymphocytic Leukemia

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 56 (estimated)
• Sponsor: Cancer Research UK · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

RATIONALE: Drugs used in chemotherapy, such as fludarabine, cyclophosphamide, and mitoxantrone, 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 combination chemotherapy together with rituximab may kill more cancer cells. It is not yet known whether giving combination chemotherapy together with rituximab is more effective than combination chemotherapy alone in treating chronic lymphocytic leukemia. PURPOSE: This randomized phase II trial is studying how well giving combination chemotherapy with or without rituximab works in treating patients with previously treated chronic lymphocytic leukemia.

Detailed description

OBJECTIVES: Primary * Assess the efficacy and safety of fludarabine, cyclophosphamide, and mitoxantrone hydrochloride with or without rituximab in patients with previously treated chronic lymphocytic leukemia. * Determine the overall response rate, defined as complete or partial remission, in these patients. Secondary * Determine the proportion of patients with undetectable minimal residual disease. * Determine the 2-year progression-free survival of these patients. * Determine the 2-year overall survival of these patients. * Determine the toxicity of this regimen. OUTLINE: This is a randomized, controlled, open-label, parallel group, multicenter study. Patients are stratified according to prior treatment with fludarabine (refractory vs not refractory or naive). Patients are randomized to 1 of 2 treatment arms. * Arm I: Patients receive oral fludarabine\* and oral cyclophosphamide\* on days 1-5 and mitoxantrone hydrochloride IV on day 1. * Arm II: Patients receive fludarabine\*, cyclophosphamide\*, and mitoxantrone hydrochloride as in arm I. Patients also receive rituximab IV on day 1. NOTE: \*If the oral regimen is not tolerated, patients may receive fludarabine IV and cyclophosphamide IV on days 1-3. Treatment in both arms repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed periodically for 3 years. Peer Reviewed and Funded or Endorsed by Cancer Research UK PROJECTED ACCRUAL: A total of 56 patients will be accrued for this study.

Conditions

• Leukemia

Interventions

Type	Name	Description
BIOLOGICAL	rituximab
DRUG	cyclophosphamide
DRUG	fludarabine phosphate
DRUG	mitoxantrone hydrochloride

Timeline

• Start date: 2005-07-01
• Completion: 2011-03-01
• First posted: 2006-06-15
• Last updated: 2013-08-02

Locations

16 sites across 1 country: United Kingdom