Fludarabine, Cyclophosphamide, and Rituximab in Treating Patients With Prolymphocytic Leukemia

Phase II Trial of Combined Immunochemotherapy With Fludarabine, Cyclophosphamide and Rituximab in Patients With B-PLL

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00281931

Enrollment

Registered

2006-01-25

Start date

1999-09-30

Completion date

2006-10-31

Last updated

2016-09-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prolymphocytic Leukemia

Keywords

prolymphocytic leukemia

Brief summary

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.

Detailed description

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.

Interventions

BIOLOGICALrituximab

DRUGcyclophosphamide

DRUGfludarabine phosphate

Study design

Allocation

NON_RANDOMIZED

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Overall survival	—
Progression-free survival	—
Toxicity	—

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026