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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 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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00003248
The ClinicalTrials.gov registry entry for NCT00003248 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 104 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 486-participant average among 233 other Leukemia trials with a reported enrollment target (79% lower). The listed sponsor is Alliance for Clinical Trials in Oncology, which has 446 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 13 distinct geographic areas - top geographies include 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.
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Related
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