A Randomized Phase II Trial of Fludarabine, Cyclophosphamide and Mitoxantrone (FCM) With or Without Rituximab in Previously Treated Chronic Lymphocytic Leukemia
N/A
N/A
Both
Leukemia
Trial Information
A Randomized Phase II Trial of Fludarabine, Cyclophosphamide and Mitoxantrone (FCM) With or Without Rituximab in Previously Treated Chronic Lymphocytic Leukemia
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.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Diagnosis of chronic lymphocytic leukemia requiring therapy
- Previously treated with ≥ 1 chemotherapeutic regimen
PATIENT CHARACTERISTICS:
- WHO performance status 0-2
- Life expectancy ≥ 12 weeks
- Creatinine clearance ≥ 30 mL/min
- Not pregnant or nursing
- Negative pregnancy test
- Fertile female patients must use effective contraception for 4 weeks before, during,
and for 6 months after completion of study treatment
- Fertile male patients must use effective contraception during and for 6 months after
completion of study treatment
- No history of anaphylaxis after exposure to rat or mouse-derived
complementary-determining region (CDR)-grafted humanized monoclonal antibodies
- No toxicity attributable to purine analogues (e.g., autoimmune hemolytic anemia,
neurological toxicity, or allergy)
- No active infection
- No other severe (particularly cardiac or pulmonary) diseases or mental disorders that
would preclude study participation
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior fludarabine (or other purine analogues) combined with cyclophosphamide and
mitoxantrone hydrochloride
- No prior rituximab, either alone or in combination with chemotherapy
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Overall response rate as measured by NCI Response Criteria
Safety Issue:
No
Principal Investigator
Peter Hillmen, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Leeds General Infirmary
Authority:
United States: Federal Government
Study ID:
CDR0000485181
NCT ID:
NCT00337246
Start Date:
July 2005
Completion Date:
Related Keywords:
- Leukemia
- refractory chronic lymphocytic leukemia
- stage I chronic lymphocytic leukemia
- stage II chronic lymphocytic leukemia
- stage III chronic lymphocytic leukemia
- stage IV chronic lymphocytic leukemia
- Leukemia
- Leukemia, Lymphocytic, Chronic, B-Cell
- Leukemia, Lymphoid
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