Phase II Trial of Combined Immunochemotherapy With Fludarabine, Cyclophosphamide and Rituximab in Patients With B-PLL
18 Years
75 Years
Both
Leukemia
Trial Information
Phase II Trial of Combined Immunochemotherapy With Fludarabine, Cyclophosphamide and Rituximab in Patients With B-PLL
OBJECTIVES:
- Determine the overall and progression-free survival of patients with B-cell
prolymphocytic leukemia treated with immunochemotherapy comprising fludarabine,
cyclophosphamide, and rituximab.
- Determine the toxic effects of this regimen in these patients.
OUTLINE: This is a non-randomized, open-label, multicenter study.
Patients receive fludarabine IV and cyclophosphamide IV on days 1-3. Patients also receive
rituximab IV on day 0 in course 1 and on day 1 in courses 2-6. Treatment repeats every 28
days for up to 6 courses.
PROJECTED ACCRUAL: A total of 21 patients will be accrued for this study.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Diagnosis of B-cell prolymphocytic leukemia
- Previously treated disease
- All Binet stages allowed
PATIENT CHARACTERISTICS:
- Life expectancy > 3 months
- ECOG/WHO performance status 0-3
PRIOR CONCURRENT THERAPY:
- No more than 3 prior treatment regimens
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Overall survival
Safety Issue:
No
Principal Investigator
Michael Herold, MD, PhD
Investigator Role:
Study Chair
Investigator Affiliation:
Helios Klinikum Erfurt
Authority:
United States: Federal Government
Study ID:
CDR0000454581
NCT ID:
NCT00281931
Start Date:
September 1999
Completion Date:
Related Keywords:
- Leukemia
- prolymphocytic leukemia
- Leukemia
- Leukemia, Prolymphocytic
Name | Location |
|---|
