CompletedInterventionalPhase 2Last updated Jul 20, 2016

Fludarabine and Monoclonal Antibody Therapy in Treating Patients With Untreated B-cell Chronic Lymphocytic Leukemia

A Randomized Phase II Study of Concurrent Fludarabine + Chimeric Anti-CD20 Monoclonal Antibody IDEC-C2B8 (Rituximab) [NSC# 687451] Induction Followed By Rituximab Consolidation In Untreated Patients With B-Cell Chronic Lymphocytic Leukemia

Overview

ClinicalTrials.gov ID: NCT00003248
Lead Sponsor: Alliance for Clinical Trials in OncologyOTHER
Brief 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.

Status

Overall Status: Completed
Start Date: Mar 1998
Primary Completion Date: Apr 2003Actual
Completion Date: Jun 2010Actual

Study Record Dates

First Submitted: Nov 1, 1999
First Submitted that Met QC Criteria: Sep 9, 2004
First Posted: Sep 10, 2004Estimated
Last Update Submitted that Met QC Criteria: Jul 19, 2016
Last Update Posted: Jul 20, 2016Estimated
Last Verified: Jul 2016

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