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Alternate Title
Basic Trial Information
Trial Description
     Purpose
     Eligibility
     Treatment/Intervention
Trial Contact Information
Registry Information

Alternate Title

Phase III Randomized Study of Chlorambucil Alone Versus Fludarabine With or Without Cyclophosphamide in Patients With Newly Diagnosed Chronic Lymphocytic Leukemia

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Treatment	Closed	Not specified	Other	LRF-CLL4 LRG-MRC-LEUK-CLL4, EU-99030, MRC-LEUK-CLL4, NCT00004218, EUDRACT-58585610, ISRCTN58585610

Trial Description

Purpose:

Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. It is not yet known which regimen of chemotherapy is more effective for chronic lymphocytic leukemia.

This randomized phase III trial is studying chlorambucil to see how well it works compared to fludarabine and cyclophosphamide or fludarabine alone in treating patients with newly diagnosed chronic lymphocytic leukemia.

Eligibility:

Eligibility criteria include the following:

• No previous therapy for this disease
• For more information about the eligibility criteria for this trial, refer to the Health Professional version.

Final eligibility for a clinical trial is determined by the health professionals conducting the trial.

Treatment/Intervention:

Patients will be randomly assigned to one of three groups. Patients in group one will receive chlorambucil by mouth once a day for 1 week. Treatment may be repeated every 4 weeks for up to 1 year. Patients in group two will receive fludarabine by infusion or by mouth for 5 days every 4 weeks for up to eight courses. Patients in group three will receive infusions of cyclophosphamide for 3 days and infusions of fludarabine for 3 days or by mouth once a day for 5 days every 4 weeks for up to eight courses. Patients may then receive additional chemotherapy. Quality of life will be assessed before, during, and after therapy. Patients will receive follow-up evaluations once a year.

Important:

For more details about this trial, refer to the Health Professional version of the trial summary.

If you are interested in participating in a clinical trial, contact your doctor for a referral or call a trial contact person listed below. You may see the same contact person listed at more than one site, however, if you call the number listed you can ask to speak to the study coordinator or person involved with the specific trial you are interested in. If you have questions about cancer or clinical trials, call the Cancer Information Service at 1-800-4-CANCER (1-800-422-6237). General information about clinical trials, including risks, benefits, and costs, can be found on NCI's Web site.

Trial Contact Information

Trial Lead Organizations

Leukemia Research Fund

Daniel Catovsky, MD, Protocol chair		Ph: 44-20-7808-2880 ext.2875 Email: daniel.catovsky@icr.ac.uk

Medical Research Council's Working Party on Leukemia in Adults and Children

Daniel Catovsky, MD, Protocol chair		Ph: 44-20-7808-2880 ext.2875 Email: daniel.catovsky@icr.ac.uk

Registry Information
Official Title		Chronic Lymphocytic Leukemia Trial 4: A Randomized Comparison of Chlorambucil, Fludarabine and Fludarabine Plus Cyclophosphamide
Trial Start Date		1999-10-09
Registered in ClinicalTrials.gov		NCT00004218
Date Submitted to PDQ		1999-12-03
Information Last Verified		2006-01-23

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