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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 Prednisone and Cyclosporine With Versus Without Hydroxychloroquine in Patients With Newly Diagnosed Extensive Chronic Graft-Versus-Host Disease

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Supportive care	Completed	1 to 29	NCI	COG-ASCT0031 CCG-S9701, NCI-P02-0213, ASCT0031, NCT00031824

Trial Description

Purpose:

Hydroxychloroquine may decrease the immune response and be effective in treating chronic graft-versus-host disease. It is not yet known if standard therapy for graft-versus-host disease is more effective with or without hydroxychloroquine.

Randomized phase III trial to compare the effectiveness of standard therapy alone with that of standard therapy plus hydroxychloroquine in treating patients who have newly diagnosed chronic graft-versus-host disease.

Eligibility:

Eligibility criteria include the following:

• Younger than 30 years old
• Received previous donor bone marrow transplantation, peripheral stem cell transplantation, or cord blood transplantation
• 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 hydroxychloroquine by mouth twice a day.

Patients in group two will receive a placebo by mouth twice a day.

Patients in both groups will receive standard therapy consisting of prednisone by mouth or by infusion up to three times a day and cyclosporine or tacrolimus by mouth or infusion twice a day.

Treatment in both groups may continue for up to 9 months. Quality of life will be assessed periodically. Patients will be evaluated once a month for 3 months and at 9 months.

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

Children's Oncology Group

Andrew Gilman, MD, Protocol chair		Ph: 919-966-9631 Email: agilman@med.unc.edu

Registry Information
Official Title		Phase III Trial of Hydroxychloroquine + Standard Therapy for Chronic Graft-Versus-Host Disease
Trial Start Date		2002-04-01
Registered in ClinicalTrials.gov		NCT00031824
Date Submitted to PDQ		2002-01-16
Information Last Verified		2005-06-30
NCI Grant/Contract Number		CA98543

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