Phase III Trial of Hydroxychloroquine + Standard Therapy for Chronic Graft-Versus-Host Disease
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.
Interventional
Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Supportive Care
Andrew L. Gilman, MD
Study Chair
UNC Lineberger Comprehensive Cancer Center
United States: Federal Government
CDR0000069231
NCT00031824
April 2002
Name | Location |
---|---|
Baylor College of Medicine | Houston, Texas 77030 |
Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |
University of Michigan Comprehensive Cancer Center | Ann Arbor, Michigan 48109-0752 |
Children's Hospital of Philadelphia | Philadelphia, Pennsylvania 19104 |
University of Chicago Cancer Research Center | Chicago, Illinois 60637 |
University of Minnesota Cancer Center | Minneapolis, Minnesota 55455 |
University of Mississippi Medical Center | Jackson, Mississippi 39216-4505 |
Duke Comprehensive Cancer Center | Durham, North Carolina 27710 |
Children's Hospital of Michigan | Detroit, Michigan 48201 |
University of Texas Health Science Center at San Antonio | San Antonio, Texas 78284-7811 |
Midwest Children's Cancer Center | Milwaukee, Wisconsin 53226 |
Presbyterian - St. Luke's Medical Center | Denver, Colorado 80218 |
Massachusetts General Hospital Cancer Center | Boston, Massachusetts 02114 |
Kaiser Permanente Medical Center - Los Angeles | Los Angeles, California 90027 |
New York Medical College | Valhalla, New York 10595 |
Deaconess Medical Center | Spokane, Washington 99210-0248 |
University of Wisconsin Comprehensive Cancer Center | Madison, Wisconsin 53792 |
Holden Comprehensive Cancer Center at University of Iowa | Iowa City, Iowa 52242-1002 |
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill | Chapel Hill, North Carolina 27599-7570 |
CCOP - Columbia River Oncology Program | Portland, Oregon 97225 |
CCOP - Scott and White Hospital | Temple, Texas 76508 |
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Baltimore, Maryland 21231-2410 |
CCOP - St. Vincent Hospital Cancer Center, Green Bay | Green Bay, Wisconsin 54301 |
Cancer Research Center of Hawaii | Honolulu, Hawaii 96813 |
MBCCOP - LSU Health Sciences Center | New Orleans, Louisiana 70112 |
Madigan Army Medical Center | Tacoma, Washington 98431-5048 |
Children's Hospital Los Angeles | Los Angeles, California 90027-0700 |
Children's Hospital of Orange County | Orange, California 92668 |
Children's National Medical Center | Washington, District of Columbia 20010-2970 |
Children's Mercy Hospital | Kansas City, Missouri 64108 |
Children's Hospital of Pittsburgh | Pittsburgh, Pennsylvania 15213 |
Children's Hospital and Regional Medical Center - Seattle | Seattle, Washington 98105 |
Nemours Children's Clinic | Jacksonville, Florida 32207 |
Miami Children's Hospital | Miami, Florida 33155-4069 |
All Children's Hospital | St. Petersburg, Florida 33701 |
Children's Memorial Hospital - Chicago | Chicago, Illinois 60614 |
Children's Hospital of New Orleans | New Orleans, Louisiana 70118 |
Maine Children's Cancer Program | Scarborough, Maine 04074-9308 |
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute | Boston, Massachusetts 02115 |
Floating Hospital for Children | Boston, Massachusetts 02111 |
Cardinal Glennon Children's Hospital | Saint Louis, Missouri 63104 |
Schneider Children's Hospital | New Hyde Park, New York 11042 |
St. Jude Children's Research Hospital | Memphis, Tennessee 38105-2794 |
Cook Children's Medical Center - Fort Worth | Fort Worth, Texas 76104 |
Inova Fairfax Hospital | Falls Church, Virginia 22042-3300 |
City of Hope Comprehensive Cancer Center | Duarte, California 91010 |
UCSF Comprehensive Cancer Center | San Francisco, California 94115 |
Southern California Permanente Medical Group | Downey, California 90242 |
Kosair Children's Hospital | Louisville, Kentucky 40202-3830 |
St. Louis Children's Hospital | Saint Louis, Missouri 63110 |
Arizona Cancer Center at University of Arizona Health Sciences Center | Tucson, Arizona 85724 |
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences | Little Rock, Arkansas 72205 |
Markey Cancer Center at University of Kentucky Chandler Medical Center | Lexington, Kentucky 40536-0084 |
Herbert Irving Comprehensive Cancer Center at Columbia University | New York, New York 10032 |
Cancer Institute at Oregon Health and Science University | Portland, Oregon 97201-3098 |
Ireland Cancer Center at University Hospitals of Cleveland and Case Western Reserve University | Cleveland, Ohio 44106 |
Oklahoma University Medical Center | Oklahoma City, Oklahoma 73104 |
M.D. Anderson Cancer Center at University of Texas | Houston, Texas 77030 |
University of Florida Shands Cancer Center | Gainesville, Florida 32610-0232 |
NYU Cancer Institute at New York University Medical Center | New York, New York 10016 |
SUNY Upstate Medical University Hospital | Syracuse, New York 13210 |
Cincinnati Children's Hospital Medical Center | Cincinnati, Ohio 45229-3039 |
Hollings Cancer Center at Medical University of South Carolina | Charleston, South Carolina 29425 |
CCOP - Marshfield Clinic Research Foundation | Marshfield, Wisconsin 54449 |
James P. Wilmot Cancer Center at University of Rochester Medical Center | Rochester, New York 14642 |
Lombardi Cancer Center at Georgetown University Medical Center | Washington, District of Columbia 20007 |
UNMC Eppley Cancer Center at the University of Nebraska Medical Center | Omaha, Nebraska 68198-7680 |
Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center | Los Angeles, California 90048-1865 |
Jonsson Comprehensive Cancer Center at UCLA | Los Angeles, California 90095-1781 |
Lucile Packard Children's Hospital at Stanford University Medical Center | Palo Alto, California 95798 |
AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Scottish Rite Campus | Atlanta, Georgia 30342 |
Children's Hospital and Research Center at Oakland | Oakland, California 94609-1809 |
Children's Hospital and Health Center, San Diego | San Diego, California 92123-4282 |
MBCCOP-Medical College of Georgia Cancer Center | Augusta, Georgia 30912-4000 |
Riley Children Cancer Center at Riley Hospital for Children | Indianapolis, Indiana 46202-5225 |
Cancer Center at Hackensack University Medical Center | Hackensack, New Jersey 07601 |
Doernbecher Children's Hospital at Oregon Health & Science University | Portland, Oregon 97239-3098 |
Vanderbilt Children's Hospital | Nashville, Tennessee 37232-6310 |
Simmons Cancer Center at University of Texas Southwestern Medical Center - Dallas | Dallas, Texas 75390-9063 |
MBCCOP - South Texas Pediatrics | San Antonio, Texas 78229-3900 |
Children's Hospital Cancer Center | Denver, Colorado 80218 |
DeVos Children's Hospital | Grand Rapids, Michigan 49503 |
Children's Hospitals and Clinics - Minneapolis/St. Paul | Minneapolis, Minnesota 55404 |
Columbus Children's Hospital | Columbus, Ohio 43205-2696 |
Huntsman Cancer Institute at University of Utah | Salt Lake City, Utah 84112 |
Children's Hospital at Milton S. Hershey Medical Center | Hershey, Pennsylvania 17033 |
University Medical Center at Princeton | Los Angeles, California 90027-0700 |
Methodist Cancer Center at Methodist Specialty and Transplant Hospital | Saint Louis, Missouri 63104 |
Pediatric Hematology and Oncology Associates of South Texas, PLLC | San Antonio, Texas 78229 |