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Clinical Trials/NCT00031824
NCT00031824CompletedPhase 3

Phase III Trial of Hydroxychloroquine + Standard Therapy for Chronic Graft-Versus-Host Disease

Children's Oncology Group203 sites in 1 country82 target enrollmentStarted: April 2002Last updated:
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Conditions
Drugs

Trial Snapshot

Phase
Phase 3
Status
Completed
Enrollment
82
Locations
203
Primary Endpoint
Progression Free Survival
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

RATIONALE: 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.

PURPOSE: 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.

Detailed Description

OBJECTIVES:

Primary

  • Compare the efficacy of prednisone and cyclosporine with vs without hydroxychloroquine in patients with newly diagnosed extensive chronic graft-versus-host disease (GVHD).

Secondary

  • Compare the event-free and overall survival in patients treated with these regimens.
  • Compare the health-related quality of life, including longitudinal change in and magnitude of persistent disability, in patients treated with these regimens.
  • Correlate cytokine levels and T-helper cell subtypes with chronic GVHD activity and response in patients treated with these regimens.
  • Correlate whole blood hydroxychloroquine levels with response and toxicity in patients treated with these regimens.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Single Group
Primary Purpose
Supportive Care
Masking
Double

Eligibility Criteria

Ages
1 Year to 29 Years (Child, Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Progression Free Survival

Time Frame: Length of study

Secondary Outcomes

  • Compare the efficacy of a two-drug regimen(Length of study)
  • Compare conventional outcomes measures(Length of study)
  • To determine if cytokine levels and T helper cell subtypes (Th1 and Th2) correlate with chronic GVHD activity and response(Length of study)
  • Determine if whole blood hydroxychloroquine levels correlate with response and toxicity.

Investigators

Sponsor Class
Network
Responsible Party
Sponsor

Study Sites (203)

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