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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, Mitoxantrone, and Dexamethasone Versus Fludarabine, Mitoxantrone, and Dexamethasone in Patients With Newly Diagnosed Stage III or IV Follicular Non-Hodgkin's Lymphoma

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Treatment	Closed	18 to 70	Other	BNLI-MCD/FMD EU-20035, NCT00006250

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 combination chemotherapy regimen is more effective for non-Hodgkin's lymphoma.

Randomized phase III trial to compare the effectiveness of two different combination chemotherapy regimens in treating patients who have stage III or stage IV non-Hodgkin's lymphoma.

Eligibility:

Eligibility criteria include the following:

• 18-70 years old
• No CNS involvement
• No previous therapy for non-Hodgkin's lymphoma
• 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 two groups. Patients in group one will receive an infusion of mitoxantrone on day 1, chlorambucil by mouth on days 1-10, and dexamethasone by mouth on days 1-5. Patients in group two will receive mitoxantrone and dexamethasone as in group one and an infusion of fludarabine on days 1-3. Treatment in both groups may be repeated every 4 weeks for up to eight courses. Patients will receive follow-up evaluations at 3, 6, and 12 months, every 6 months for 1 year, and once a year thereafter.

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

Lymphoma Trials Office

Andy Haynes, MD, Protocol chair		Ph: 0115-9691169 ext. 46704 Email: andy.haynes@nottingham.ac.uk

Registry Information
Official Title		Randomized Trial of MCD Versus FMD in Untreated Advanced Follicular Lymphoma
Trial Start Date		2000-05-31
Registered in ClinicalTrials.gov		NCT00006250
Date Submitted to PDQ		2000-07-14
Information Last Verified		2007-03-26

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