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

NCT ID: NCT00281931

Last Updated: 2016-09-26

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1999-09-30
• Study Completion Date: 2006-10-31

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.

Conditions

Prolymphocytic Leukemia

Study Design

• Allocation Method: NON_RANDOMIZED
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

rituximab

Intervention Type: BIOLOGICAL

cyclophosphamide

Intervention Type: DRUG

fludarabine phosphate

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

German CLL Study Group

OTHER

Sponsor Role: lead

Principal Investigators

Michael Herold, MD, PhD

Role: STUDY_CHAIR

HELIOS Hospital, Erfurt, Germany

Locations

Helios Klinikum Erfurt

Erfurt, , Germany

Countries

Germany

Other Identifiers

EU-20563

Identifier Type: -

Identifier Source: secondary_id

PLL1

Identifier Type: -

Identifier Source: org_study_id