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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.

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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

FieldValue
Enrollment Target 104 participants
Start Date 1998-03
Est. Completion 2010-06
Phase Phase 2

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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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.