Clinical trialNCT00003764CompletedPhase 3Interventional

Fludarabine With or Without Cyclophosphamide in Treating Patients With Chronic Lymphocytic Leukemia

SponsorEastern Cooperative Oncology GroupEnrollment280Leukemia

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. It is not yet known whether combining cyclophosphamide with fludarabine is more effective than fludarabine alone in treating chronic lymphocytic leukemia. PURPOSE: Randomized phase III trial to study the effectiveness of fludarabine with or without cyclophosphamide in treating patients who have chronic lymphocytic leukemia that has not been treated previously.

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Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

Ian W. Flinn, MD, PhD
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study ChairKOL profile →
clinicaltrials.gov ↗
Michael R. Grever, MD
Ohio State University Comprehensive Cancer Center
Study Chair
clinicaltrials.gov ↗
Mohamad A. Hussein, MD
The Cleveland Clinic
Study Chair
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

218 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Canada

Mcgill University
Montreal, Quebec, Canada

Puerto Rico

University of Puerto Rico School of Medicine Medical Sciences Campus
San Juan, Puerto Rico

South Africa

Pretoria Academic Hospital
Pretoria, South Africa

United States

Northeast Alabama Regional Medical Center
Anniston, Alabama, United States
University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham, Alabama, United States
Mbccop - Gulf Coast
Mobile, Alabama, United States
Ccop - Western Regional, Arizona
Phoenix, Arizona, United States
Veterans Affairs Medical Center - Phoenix (carl T. Hayden)
Phoenix, Arizona, United States
Arizona Cancer Center at University of Arizona Health Sciences Center
Tucson, Arizona, United States
Veterans Affairs Medical Center - Tucson
Tucson, Arizona, United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
Veterans Affairs Medical Center - Little Rock (mcclellan)
Little Rock, Arkansas, United States
City of Hope Comprehensive Cancer Center
Duarte, California, United States
Rebecca and John Moores Ucsd Cancer Center
La Jolla, California, United States
Cedars-Sinai Comprehensive Cancer Center at Cedars-Sinai Medical Center
Los Angeles, California, United States
Jonsson Comprehensive Cancer Center, Ucla
Los Angeles, California, United States
Usc/norris Comprehensive Cancer Center and Hospital
Los Angeles, California, United States
Veterans Affairs Outpatient Clinic - Martinez
Martinez, California, United States
Ccop - Bay Area Tumor Institute
Oakland, California, United States
Chao Family Comprehensive Cancer Center at University of California Irvine Cancer Center
Orange, California, United States
University of California Davis Cancer Center
Sacramento, California, United States
Veterans Affairs Medical Center - San Diego
San Diego, California, United States
Veterans Affairs Medical Center - San Francisco
San Francisco, California, United States
Ccop - Santa Rosa Memorial Hospital
Santa Rosa, California, United States
David Grant Medical Center
Travis Air Force Base, California, United States
Medical Center of Aurora - South Campus
Aurora, Colorado, United States
University of Colorado Cancer Center at University of Colorado Health Sciences Center
Aurora, Colorado, United States
Boulder Community Hospital
Boulder, Colorado, United States
Penrose Cancer Center
Colorado Springs, Colorado, United States
Ccop - Colorado Cancer Research Program, Incorporated
Denver, Colorado, United States
Porter Adventist Hospital
Denver, Colorado, United States
Presbyterian-St Luke'S Medical Center
Denver, Colorado, United States
Rocky Mountain Cancer Centers - Rose
Denver, Colorado, United States
St. Joseph Hospital
Denver, Colorado, United States
Swedish Medical Center
Englewood, Colorado, United States
Sky Ridge Medical Center
Lone Tree, Colorado, United States
Longmont United Hospital
Longmont, Colorado, United States
St. Mary-Corwin Regional Medical Center
Pueblo, Colorado, United States
Rocky Mountain Cancer Centers
Thornton, Colorado, United States
Ccop - Christiana Care Health Services
Newark, Delaware, United States

178 more sites on the registry record.ClinicalTrials.gov ↗

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Cyclophosphamide →Fludarabine →

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 9 Mar 2000
Primary completion: 30 Nov 2005
Completion: —
Last update posted: 18 Jun 2023
Registered enrollment: 280
Registry id: NCT00003764

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.