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

Prolymphocytic Leukemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00281931
• Other study ID #: PLL1
• Secondary ID: EU-20563
• Status: Terminated
• Phase: Phase 2
• First received: January 24, 2006
• Last updated: September 23, 2016
• Start date: September 1999
• Est. completion date: October 2006

Study information

• Verified date: September 2016
• Source: German CLL Study Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 21
• Est. completion date: October 2006
• Est. primary completion date: April 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Leukemia
• Leukemia, Prolymphocytic
• Prolymphocytic Leukemia

Intervention

Biological:
• rituximab

Drug:
• cyclophosphamide

• fludarabine phosphate

Locations

Country	Name	City	State
Germany	Helios Klinikum Erfurt	Erfurt

Sponsors (1)

Lead Sponsor	Collaborator
German CLL Study Group

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival			No
Primary	Progression-free survival			No
Primary	Toxicity			Yes

External Links

•   Click here for more information about this study: PLL1 (German CLL Study Group)