Fludarabine and Monoclonal Antibody Therapy in Treating Patients With Untreated B-cell Chronic Lymphocytic Leukemia
Part of paid clinical trials in La Jolla, California.
- Sponsor
- Alliance for Clinical Trials in Oncology
- Study ID
- NCT00003248
- Phase
- PHASE2
- Status
- Completed
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- rituximab — BIOLOGICAL
- fludarabine phosphate — DRUG
Study Details
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Combining monoclonal antibody therapy with chemotherapy may kill more cancer cells. PURPOSE: Randomized phase II trial to compare the effectiveness of fludarabine given with or without monoclonal antibody therapy followed by monoclonal antibody therapy alone in treating patients who have untreated B-cell chronic lymphocytic leukemia.
Key Dates
- Start date
- Mar 31, 1998
- Status verified
- Jul 2016
- Primary completion
- Apr 30, 2003
- Completion
- Jun 30, 2010
Study Design
- Enrollment
- 104 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Arm IPatients receive fludarabine and chimeric anti-CD20 monoclonal antibody IDEC-C2B8 (rituximab) induction. Rituximab is administered IV over 4 hours on day 1, on day 3, and over 1 hour on day 5 of week 1. Subsequent doses are given over 1 hour on day 1 every 4 weeks for a total of 6 courses. Fludarabine IV is administered over 10-30 minutes daily for 5 days during weeks 1, 5, 9, 13, 17, and 21 for a total of 6 courses. Following the sixth course of fludarabine, patients undergo clinical staging and are then observed for an additional 2 months, after which they undergo repeat clinical staging, including bone marrow aspiration. Patients achieving a complete or partial response or stable disease then proceed to consolidation therapy consisting of weekly intravenous infusions of rituximab once weekly for 4 weeks. Patients are followed every 3 months for 1 year, and then every 6 months thereafter.
- Experimental: Arm IIPatients receive fludarabine induction. Patients receive fludarabine IV over 10-30 minutes daily for 5 days during weeks 1, 5, 9, 13, 17, and 21 for a total of 6 courses. Patients then proceed as in arm I. Patients are followed every 3 months for 1 year, and then every 6 months thereafter.
Primary Outcome Measure
progression-free survival [ Time Frame: Up to 5 years ]
Locations (34)
Find similar trials in La Jolla, CA
By condition
By specialty
By research site
University of California San Diego Cancer Center· La Jolla, CAUCSF Cancer Center and Cancer Research Institute· San Francisco, CACCOP - Christiana Care Health Services· Wilmington, DEWalter Reed Army Medical Center· Washington D.C., DCCCOP - Mount Sinai Medical Center· Miami Beach, FLUniversity of Chicago Cancer Research Center· Chicago, IL
Related Studies
- Bone Marrow Grafting for Leukemia and LymphomaEnrolling By Invitation · Stanford University · Stanford, California
- Ascertainment of Families for Genetic Studies of Familial Lymphoproliferative DisordersRecruiting · Memorial Sloan Kettering Cancer Center · Basking Ridge, New Jersey
- Tissue, Blood, and Body Fluid Sample Collection From Patients With Hematologic CancerRecruiting · UNC Lineberger Comprehensive Cancer Center · Chapel Hill, North Carolina
- Registry of Older Patients With CancerRecruiting · UNC Lineberger Comprehensive Cancer Center · Boone, North Carolina