A Randomized Phase II Trial of Fludarabine, Cyclophosphamide and Mitoxantrone (FCM) With or Without Rituximab in Previously Treated Chronic Lymphocytic Leukemia
- Assess the efficacy and safety of fludarabine, cyclophosphamide, and mitoxantrone
hydrochloride with or without rituximab in patients with previously treated chronic
- Determine the overall response rate, defined as complete or partial remission, in these
- 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.
Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
Overall response rate as measured by NCI Response Criteria
Peter Hillmen, MD
Leeds General Infirmary
United States: Federal Government