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NCT00003248 · ClinicalTrials.gov registry record · Phase 2
Fludarabine and Monoclonal Antibody Therapy in Treating Patients With Untreated B-cell Chronic Lymphocytic Leukemia
A Phase 2 study of Leukemia, sponsored by Alliance for Clinical Trials in Oncology.
- Completed
- Registry status
- Phase 2
- Development phase
- 104
- Enrollment target
- 20
- Study locations
NCT00003248: Completed Phase 2 study of Leukemia, sponsored by Alliance for Clinical Trials in Oncology.
NCT00003248 is a Phase 2 study of Leukemia that has completed, run by Alliance for Clinical Trials in Oncology. The registered enrollment target is 104 participants, below the 486-participant average among 233 other Leukemia trials with a reported enrollment target (79% lower). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00003248, a Phase 2 study of Leukemia, has completed, sponsored by Alliance for Clinical Trials in Oncology.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 104 participants
- Enrollment target
- 20
- Study locations
Study Summary
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.
Conditions Studied
Interventions
- BIOLOGICAL rituximab
- DRUG fludarabine phosphate
Study Locations (20)
Massachusetts
- Massachusetts General Hospital Cancer Center - Boston
- Dana-Farber Cancer Institute - Boston
- University of Massachusetts Memorial Medical Center - Worcester
New York
- Roswell Park Cancer Institute - Buffalo
- CCOP - North Shore University Hospital - Manhasset
- North Shore University Hospital - Manhasset
California
- University of California San Diego Cancer Center - La Jolla
- UCSF Cancer Center and Cancer Research Institute - San Francisco
Illinois
- University of Illinois at Chicago Health Sciences Center - Chicago
- University of Chicago Cancer Research Center - Chicago
Missouri
- Ellis Fischel Cancer Center - Columbia - Columbia
- Barnes-Jewish Hospital - St Louis
Delaware
- CCOP - Christiana Care Health Services - Wilmington
District of Columbia
- Walter Reed Army Medical Center - Washington D.C.
Florida
- CCOP - Mount Sinai Medical Center - Miami Beach
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 104 participants |
| Start Date | 1998-03 |
| Est. Completion | 2010-06 |
| Phase | Phase 2 |
What the finished NCT00003248 record still lists
NCT00003248 is an interventional study that assigns participants to a tested intervention. The registered 104 participants enrollment target is mid-sized for trials with a published cap, below the 486-participant average among 233 other Leukemia trials with a reported enrollment target (79% lower).
The record links to 1 condition, with Leukemia appearing as the primary indexed condition, and to 2 interventions - of which rituximab is the first listed.
NCT00003248 names 20 study sites across 13 states, led by Massachusetts, New York, California.
Frequently Asked Questions
What is clinical trial NCT00003248 about?
NCT00003248 is a clinical study titled "Fludarabine and Monoclonal Antibody Therapy in Treating Patients With Untreated B-cell Chronic Lymphocytic Leukemia". 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...
What is the current status of trial NCT00003248?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 104 participants. The study started on 1998-03. Estimated completion is 2010-06.
What conditions does trial NCT00003248 study?
This clinical trial studies the following conditions: Leukemia.
What interventions are being tested in trial NCT00003248?
The interventions under investigation include: rituximab (BIOLOGICAL), fludarabine phosphate (DRUG).
Who is sponsoring clinical trial NCT00003248?
This trial is sponsored by Alliance for Clinical Trials in Oncology, which has 446 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00003248 being conducted?
This trial has 20 study locations across California, Delaware, District of Columbia, Florida, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Leukemia
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00003248's enrollment target sits among peer trials
104 57th of 233 higher than 176 of 233 other Leukemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Leukemia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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