Fludarabine, Cyclophosphamide, and Rituximab in Treating Patients With Prolymphocytic Leukemia
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|ClinicalTrials.gov Identifier: NCT00281931|
Recruitment Status : Terminated
First Posted : January 25, 2006
Last Update Posted : September 26, 2016
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 find cancer cells and kill them or carry cancer-killing substances to them. Others interfere with the ability of cancer cells to grow and spread. Giving fludarabine and cyclophosphamide together with rituximab may kill more cancer cells.
PURPOSE: This phase II trial is studying how well giving fludarabine and cyclophosphamide together with rituximab works in treating patients with B-cell prolymphocytic leukemia.
|Condition or disease||Intervention/treatment||Phase|
|Prolymphocytic Leukemia||Biological: rituximab Drug: cyclophosphamide Drug: fludarabine phosphate||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||21 participants|
|Masking:||None (Open Label)|
|Official Title:||Phase II Trial of Combined Immunochemotherapy With Fludarabine, Cyclophosphamide and Rituximab in Patients With B-PLL|
|Study Start Date :||September 1999|
|Primary Completion Date :||April 2006|
|Study Completion Date :||October 2006|
- Overall survival
- Progression-free survival
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00281931
|Helios Klinikum Erfurt|
|Erfurt, Germany, 99012|
|Study Chair:||Michael Herold, MD, PhD||Helios Klinikum Erfurt|