Hydroxychloroquine in Treating Patients With Newly Diagnosed Chronic Graft-Versus-Host Disease
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00031824|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : February 14, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Graft Versus Host Disease||Drug: cyclosporine Drug: hydroxychloroquine Drug: prednisone Drug: tacrolimus||Phase 3|
- Compare the efficacy of prednisone and cyclosporine with vs without hydroxychloroquine in patients with newly diagnosed extensive chronic graft-versus-host disease (GVHD).
- 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.
OUTLINE: This is a randomized, placebo-controlled, double-blind, multicenter study. Patients are randomized to one of two treatment arms.
Patients may receive standard therapy comprising prednisone orally or IV 2-3 times daily or every other day and cyclosporine orally or IV twice daily or tacrolimus orally twice daily or IV by continuous infusion before randomization. Patients not receiving cyclosporine or tacrolimus prior to randomization may receive cyclosporine or tacrolimus after randomization according to institutional preference.
- Arm I: Within 10-14 days of beginning therapy with prednisone and cyclosporine or tacrolimus, patients receive oral hydroxychloroquine twice daily.
- Arm II: Patients receive standard therapy with prednisone and cyclosporine or tacrolimus as in arm I and oral placebo twice daily.
In both arms, treatment continues for 9 months in the absence of disease progression or unacceptable toxicity. Patients with no response after 2 months of therapy are taken off study.
Quality of life is assessed at baseline, 1 month, 9 months, and 1 year.
Patients are followed every month for 3 months and at 9 months.
PROJECTED ACCRUAL: A total of 232 patients (116 per treatment arm) will be accrued for this study within 3.6 years.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||82 participants|
|Intervention Model:||Single Group Assignment|
|Primary Purpose:||Supportive Care|
|Official Title:||Phase III Trial of Hydroxychloroquine + Standard Therapy for Chronic Graft-Versus-Host Disease|
|Study Start Date :||April 2002|
|Actual Primary Completion Date :||May 2005|
|Actual Study Completion Date :||January 2011|
- Progression Free Survival [ Time Frame: Length of study ]
- Compare the efficacy of a two-drug regimen [ Time Frame: Length of study ]Compare the efficacy of a two-drug regimen including prednisone and cyclosporine versus that of a three-drug regimen including hydroxychloroquine, prednisone, and cyclosporine in patients treated for newly-diagnosed extensive chronic GVHD.
- Compare conventional outcomes measures [ Time Frame: Length of study ]Compare conventional outcomes measures (event-free survival, overall survival) and health-related quality-of-life (HRQL), including longitudinal change in and magnitude of persistent disability, for the two-drug versus the three-drug regimen.
- To determine if cytokine levels and T helper cell subtypes (Th1 and Th2) correlate with chronic GVHD activity and response [ Time Frame: Length of study ]
- Determine if whole blood hydroxychloroquine levels correlate with response and toxicity.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00031824
|Study Chair:||Andrew L. Gilman, MD||UNC Lineberger Comprehensive Cancer Center|