Hydroxychloroquine in Treating Patients With Newly Diagnosed Chronic Graft-Versus-Host Disease
- Conditions
- Graft Versus Host Disease
- Registration Number
- NCT00031824
- Lead Sponsor
- Children's Oncology Group
- 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.
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 82
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Progression Free Survival Length of study
- Secondary Outcome Measures
Name Time Method Compare the efficacy of a two-drug regimen 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 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 Length of study Determine if whole blood hydroxychloroquine levels correlate with response and toxicity.
Trial Locations
- Locations (103)
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
🇺🇸Baltimore, Maryland, United States
All Children's Hospital
🇺🇸St. Petersburg, Florida, United States
Maine Children's Cancer Program
🇺🇸Scarborough, Maine, United States
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
Riley Children Cancer Center at Riley Hospital for Children
🇺🇸Indianapolis, Indiana, United States
Children's Hospital and Health Center, San Diego
🇺🇸San Diego, California, United States
UCSF Comprehensive Cancer Center
🇺🇸San Francisco, California, United States
Children's Hospitals and Clinics - Minneapolis/St. Paul
🇺🇸Minneapolis, Minnesota, United States
Duke Comprehensive Cancer Center
🇺🇸Durham, North Carolina, United States
University of Texas Health Science Center at San Antonio
🇺🇸San Antonio, Texas, United States
Huntsman Cancer Institute at University of Utah
🇺🇸Salt Lake City, Utah, United States
Pediatric Hematology and Oncology Associates of South Texas, PLLC
🇺🇸San Antonio, Texas, United States
Children's Hospital Los Angeles
🇺🇸Los Angeles, California, United States
Southern California Permanente Medical Group
🇺🇸Downey, California, United States
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
🇺🇸Little Rock, Arkansas, United States
Arizona Cancer Center at University of Arizona Health Sciences Center
🇺🇸Tucson, Arizona, United States
Kaiser Permanente Medical Center - Los Angeles
🇺🇸Los Angeles, California, United States
University of Florida Shands Cancer Center
🇺🇸Gainesville, Florida, United States
University of Michigan Comprehensive Cancer Center
🇺🇸Ann Arbor, Michigan, United States
Methodist Cancer Center at Methodist Specialty and Transplant Hospital
🇺🇸Saint Louis, Missouri, United States
AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Scottish Rite Campus
🇺🇸Atlanta, Georgia, United States
James P. Wilmot Cancer Center at University of Rochester Medical Center
🇺🇸Rochester, New York, United States
University of Mississippi Medical Center
🇺🇸Jackson, Mississippi, United States
SUNY Upstate Medical University Hospital
🇺🇸Syracuse, New York, United States
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
🇺🇸Chapel Hill, North Carolina, United States
Princess Margaret Hospital for Children
🇦🇺Perth, Western Australia, Australia
Cook Children's Medical Center - Fort Worth
🇺🇸Fort Worth, Texas, United States
Cardinal Glennon Children's Hospital
🇺🇸Saint Louis, Missouri, United States
NYU Cancer Institute at New York University Medical Center
🇺🇸New York, New York, United States
University of Minnesota Cancer Center
🇺🇸Minneapolis, Minnesota, United States
Children's Hospital at Milton S. Hershey Medical Center
🇺🇸Hershey, Pennsylvania, United States
Herbert Irving Comprehensive Cancer Center at Columbia University
🇺🇸New York, New York, United States
New York Medical College
🇺🇸Valhalla, New York, United States
Cincinnati Children's Hospital Medical Center
🇺🇸Cincinnati, Ohio, United States
St. Jude Children's Research Hospital
🇺🇸Memphis, Tennessee, United States
CancerCare Manitoba
🇨🇦Winnipeg, Manitoba, Canada
Children's Hospital of Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
Hollings Cancer Center at Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
Alberta Children's Hospital
🇨🇦Calgary, Alberta, Canada
McGill Cancer Centre at McGill University
🇨🇦Montreal, Quebec, Canada
INOVA Fairfax Hospital
🇺🇸Falls Church, Virginia, United States
Swiss Pediatric Oncology Group Lausanne
🇨ðŸ‡Lausanne, Switzerland
Hopital Sainte Justine
🇨🇦Montreal, Quebec, Canada
Starship Children's Health
🇳🇿Auckland, New Zealand
Hospital for Sick Children
🇨🇦Toronto, Ontario, Canada
St. Louis Children's Hospital
🇺🇸Saint Louis, Missouri, United States
Children's Hospital Cancer Center
🇺🇸Denver, Colorado, United States
Children's Hospital of Michigan
🇺🇸Detroit, Michigan, United States
UNMC Eppley Cancer Center at the University of Nebraska Medical Center
🇺🇸Omaha, Nebraska, United States
CCOP - Columbia River Oncology Program
🇺🇸Portland, Oregon, United States
Cancer Institute at Oregon Health and Science University
🇺🇸Portland, Oregon, United States
Doernbecher Children's Hospital at Oregon Health & Science University
🇺🇸Portland, Oregon, United States
Midwest Children's Cancer Center
🇺🇸Milwaukee, Wisconsin, United States
Schneider Children's Hospital
🇺🇸New Hyde Park, New York, United States
Children's National Medical Center
🇺🇸Washington, District of Columbia, United States
Madigan Army Medical Center
🇺🇸Tacoma, Washington, United States
Simmons Cancer Center at University of Texas Southwestern Medical Center - Dallas
🇺🇸Dallas, Texas, United States
Columbus Children's Hospital
🇺🇸Columbus, Ohio, United States
CCOP - Scott and White Hospital
🇺🇸Temple, Texas, United States
Children's Hospital and Regional Medical Center - Seattle
🇺🇸Seattle, Washington, United States
MBCCOP - South Texas Pediatrics
🇺🇸San Antonio, Texas, United States
Deaconess Medical Center
🇺🇸Spokane, Washington, United States
University of Wisconsin Comprehensive Cancer Center
🇺🇸Madison, Wisconsin, United States
Children's Hospital at Westmead
🇦🇺Westmead, New South Wales, Australia
Royal Children's Hospital
🇦🇺Parkville, Victoria, Australia
Women's and Children's Hospital
🇦🇺North Adelaide, South Australia, Australia
City of Hope Comprehensive Cancer Center
🇺🇸Duarte, California, United States
University Medical Center at Princeton
🇺🇸Los Angeles, California, United States
Children's Hospital and Research Center at Oakland
🇺🇸Oakland, California, United States
Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center
🇺🇸Los Angeles, California, United States
Jonsson Comprehensive Cancer Center at UCLA
🇺🇸Los Angeles, California, United States
Lucile Packard Children's Hospital at Stanford University Medical Center
🇺🇸Palo Alto, California, United States
Children's Hospital of Orange County
🇺🇸Orange, California, United States
Presbyterian - St. Luke's Medical Center
🇺🇸Colorado Springs, Colorado, United States
Lombardi Cancer Center at Georgetown University Medical Center
🇺🇸Washington, District of Columbia, United States
Nemours Children's Clinic
🇺🇸Jacksonville, Florida, United States
University of Chicago Cancer Research Center
🇺🇸Chicago, Illinois, United States
Miami Children's Hospital
🇺🇸Miami, Florida, United States
MBCCOP-Medical College of Georgia Cancer Center
🇺🇸Augusta, Georgia, United States
Cancer Research Center of Hawaii
🇺🇸Honolulu, Hawaii, United States
Children's Memorial Hospital - Chicago
🇺🇸Chicago, Illinois, United States
Markey Cancer Center at University of Kentucky Chandler Medical Center
🇺🇸Lexington, Kentucky, United States
Holden Comprehensive Cancer Center at University of Iowa
🇺🇸Iowa City, Iowa, United States
Kosair Children's Hospital
🇺🇸Louisville, Kentucky, United States
MBCCOP - LSU Health Sciences Center
🇺🇸New Orleans, Louisiana, United States
Children's Hospital of New Orleans
🇺🇸New Orleans, Louisiana, United States
Floating Hospital for Children
🇺🇸Boston, Massachusetts, United States
Massachusetts General Hospital Cancer Center
🇺🇸Boston, Massachusetts, United States
DeVos Children's Hospital
🇺🇸Grand Rapids, Michigan, United States
Oklahoma University Medical Center
🇺🇸Oklahoma City, Oklahoma, United States
Children's Mercy Hospital
🇺🇸Kansas City, Missouri, United States
Memorial Sloan-Kettering Cancer Center
🇺🇸New York, New York, United States
Cancer Center at Hackensack University Medical Center
🇺🇸Hackensack, New Jersey, United States
Ireland Cancer Center at University Hospitals of Cleveland and Case Western Reserve University
🇺🇸Cleveland, Ohio, United States
Children's Hospital of Pittsburgh
🇺🇸Pittsburgh, Pennsylvania, United States
Vanderbilt Children's Hospital
🇺🇸Nashville, Tennessee, United States
M.D. Anderson Cancer Center at University of Texas
🇺🇸Houston, Texas, United States
CCOP - St. Vincent Hospital Cancer Center, Green Bay
🇺🇸Green Bay, Wisconsin, United States
CCOP - Marshfield Clinic Research Foundation
🇺🇸Marshfield, Wisconsin, United States
San Jorge Children's Hospital
🇵🇷Santurce, Puerto Rico
Baylor College of Medicine
🇺🇸Houston, Texas, United States
Swiss Pediatric Oncology Group Bern
🇨ðŸ‡Bern, Switzerland
British Columbia Children's Hospital
🇨🇦Vancouver, British Columbia, Canada