Fludarabine, Cyclophosphamide, and Rituximab in Treating Patients With Prolymphocytic Leukemia
Primary Purpose
Prolymphocytic Leukemia
Status
Terminated
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
rituximab
cyclophosphamide
fludarabine phosphate
Sponsored by
About this trial
This is an interventional treatment trial for Prolymphocytic Leukemia focused on measuring prolymphocytic leukemia
Eligibility 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
Sites / Locations
- Helios Klinikum Erfurt
Outcomes
Primary Outcome Measures
Overall survival
Progression-free survival
Toxicity
Secondary Outcome Measures
Full Information
NCT ID
NCT00281931
First Posted
January 24, 2006
Last Updated
September 23, 2016
Sponsor
German CLL Study Group
1. Study Identification
Unique Protocol Identification Number
NCT00281931
Brief Title
Fludarabine, Cyclophosphamide, and Rituximab in Treating Patients With Prolymphocytic Leukemia
Official Title
Phase II Trial of Combined Immunochemotherapy With Fludarabine, Cyclophosphamide and Rituximab in Patients With B-PLL
Study Type
Interventional
2. Study Status
Record Verification Date
September 2016
Overall Recruitment Status
Terminated
Study Start Date
September 1999 (undefined)
Primary Completion Date
April 2006 (Actual)
Study Completion Date
October 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
German CLL Study Group
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prolymphocytic Leukemia
Keywords
prolymphocytic leukemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
21 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Biological
Intervention Name(s)
rituximab
Intervention Type
Drug
Intervention Name(s)
cyclophosphamide
Intervention Type
Drug
Intervention Name(s)
fludarabine phosphate
Primary Outcome Measure Information:
Title
Overall survival
Title
Progression-free survival
Title
Toxicity
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Herold, MD, PhD
Organizational Affiliation
Helios Klinikum Erfurt
Official's Role
Study Chair
Facility Information:
Facility Name
Helios Klinikum Erfurt
City
Erfurt
ZIP/Postal Code
99012
Country
Germany
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
http://www.dcllsg.de/en/trial/pll1/index.php
Description
Click here for more information about this study: PLL1 (German CLL Study Group)
Learn more about this trial
Fludarabine, Cyclophosphamide, and Rituximab in Treating Patients With Prolymphocytic Leukemia
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