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Hydroxychloroquine in Treating Patients With Newly Diagnosed Chronic Graft-Versus-Host Disease

Primary Purpose

Graft Versus Host Disease

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
cyclosporine
hydroxychloroquine
prednisone
tacrolimus
Sponsored by
Children's Oncology Group
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Graft Versus Host Disease focused on measuring graft versus host disease

Eligibility Criteria

1 Year - 29 Years (Child, Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Histologically confirmed* newly diagnosed extensive chronic graft-versus-host disease (GVHD) of ≥ 1 organ system (e.g., lip, skin, or liver) documented by all of the following: Clinicopathologic features of GVHD, including involvement of any of the following organ systems: Skin changes Oral changes Hepatic involvement Gastrointestinal involvement Sicca syndrome Pulmonary involvement Myofascial Skeletal Other inflammatory conditions (e.g., myositis, arthritis, polyserositis, or unexplained pericardial, pleural, or peritoneal effusions) Autoantibodies Extent of disease, defined according to the following classification: Limited chronic GVHD, defined by 1 of the following: Localized skin involvement and/or liver dysfunction Involvement of only 1 target organ Extensive chronic GVHD, defined by 1 of the following: Generalized skin involvement of ≥ 50% of body surface area Localized skin involvement and/or liver dysfunction AND ≥ 1 of the following: Liver histology showing chronic aggressive hepatitis, bridging necrosis, or cirrhosis Eye involvement (Schirmer's test with < 5 mm wetting) Involvement of minor salivary glands or oral mucosa on lip biopsy Involvement of any other target organs Involvement of ≥ 2 target organs Timing of onset, including onset of any of the following types: Progressive onset defined as, evolving directly from acute GVHD, commonly with the development of typical manifestations such as oral or skin lichenoid changes or sclerodermatous skin changes Quiescent onset, defined as developing after the resolution of acute GVHD De novo onset, defined as developing with no prior history of acute GVHD Must have ≥ 1 typical clinical manifestation of chronic GVHD that differs from that of acute GVHD (e.g., rash, anorexia, nausea, emesis, diarrhea, abdominal pain, or cholestasis) Symptoms of acute GVHD allowed at the time of diagnosis of chronic GVHD Prior allogeneic bone marrow, peripheral blood stem cell, or cord blood transplantation from a family member or unrelated donor for malignancy required NOTE: *Histologic confirmation may be "consistent with GVHD" PATIENT CHARACTERISTICS: Age: 1 to 29 Performance status: Lansky 50-100% OR Karnofsky 50-100% Life expectancy: At least 2 months Hematopoietic: Absolute neutrophil count ≥ 1,000/mm^3, unless due to chronic GVHD (i.e., autoimmune neutropenia or bone marrow suppression) Hepatic: See Disease Characteristics Renal: Creatinine < 1.5 times upper limit of normal OR Creatinine clearance ≥ 60 mL/min Other: Not pregnant Negative pregnancy test Fertile patients must use effective contraception during and for 3 months after study participation No lysosomal storage disorder No uncontrolled infection (e.g., persistent bacterial, fungal, or viral infection despite appropriate antimicrobial therapy) No G6PD deficiency No history of psoriasis or porphyria No hypersensitivity to 4-aminoquinolines No prior retinal or visual field changes due to 4-aminoquinolines PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics No concurrent daclizumab or infliximab No concurrent thalidomide Chemotherapy: Not specified Endocrine therapy: Prior topical steroids for treatment of extensive chronic GVHD allowed Prior adjustment to prednisone dose allowed if done as a reversal of a taper Prior steroids (prednisone ≤ 1 mg/kg/day (or equivalent) for symptom management for up to 1 week before study entry allowed Concurrent steroids for treatment and/or prophylaxis of acute GVHD allowed if prednisone dose is ≤ 2 mg/kg/day (or equivalent) Concurrent topical steroids allowed Radiotherapy: Not specified Surgery: Not specified Other: No prior treatment for extensive chronic GVHD except the following: Topical treatment (e.g., tacrolimus ointment or pimecrolimus cream) Adjustments of cyclosporine or tacrolimus doses for GVHD prophylaxis or treatment of acute GVHD Concurrent cyclosporine or tacrolimus allowed Cyclosporine must have been started before study entry No other concurrent systemic or topical immunosuppressants, including any of the following: Azathioprine Mycophenolate mofetil Psoralen-ultraviolet light therapy Photopheresis No administration of any of the following for 1 hour before until 2 hours after study drug administration: Antacids Sucralfate Cholestyramine Bicarbonate

Sites / Locations

  • Arizona Cancer Center at University of Arizona Health Sciences Center
  • Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
  • Southern California Permanente Medical Group
  • City of Hope Comprehensive Cancer Center
  • Children's Hospital Los Angeles
  • University Medical Center at Princeton
  • Kaiser Permanente Medical Center - Los Angeles
  • Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center
  • Jonsson Comprehensive Cancer Center at UCLA
  • Children's Hospital and Research Center at Oakland
  • Children's Hospital of Orange County
  • Lucile Packard Children's Hospital at Stanford University Medical Center
  • Children's Hospital and Health Center, San Diego
  • UCSF Comprehensive Cancer Center
  • Presbyterian - St. Luke's Medical Center
  • Children's Hospital Cancer Center
  • Lombardi Cancer Center at Georgetown University Medical Center
  • Children's National Medical Center
  • University of Florida Shands Cancer Center
  • Nemours Children's Clinic
  • Miami Children's Hospital
  • All Children's Hospital
  • AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Scottish Rite Campus
  • MBCCOP-Medical College of Georgia Cancer Center
  • Cancer Research Center of Hawaii
  • University of Chicago Cancer Research Center
  • Children's Memorial Hospital - Chicago
  • Riley Children Cancer Center at Riley Hospital for Children
  • Holden Comprehensive Cancer Center at University of Iowa
  • Markey Cancer Center at University of Kentucky Chandler Medical Center
  • Kosair Children's Hospital
  • MBCCOP - LSU Health Sciences Center
  • Children's Hospital of New Orleans
  • Maine Children's Cancer Program
  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
  • Floating Hospital for Children
  • Massachusetts General Hospital Cancer Center
  • Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
  • University of Michigan Comprehensive Cancer Center
  • Children's Hospital of Michigan
  • DeVos Children's Hospital
  • Children's Hospitals and Clinics - Minneapolis/St. Paul
  • University of Minnesota Cancer Center
  • University of Mississippi Medical Center
  • Children's Mercy Hospital
  • Cardinal Glennon Children's Hospital
  • Methodist Cancer Center at Methodist Specialty and Transplant Hospital
  • St. Louis Children's Hospital
  • UNMC Eppley Cancer Center at the University of Nebraska Medical Center
  • Cancer Center at Hackensack University Medical Center
  • Schneider Children's Hospital
  • NYU Cancer Institute at New York University Medical Center
  • Memorial Sloan-Kettering Cancer Center
  • Herbert Irving Comprehensive Cancer Center at Columbia University
  • James P. Wilmot Cancer Center at University of Rochester Medical Center
  • SUNY Upstate Medical University Hospital
  • New York Medical College
  • Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
  • Duke Comprehensive Cancer Center
  • Cincinnati Children's Hospital Medical Center
  • Ireland Cancer Center at University Hospitals of Cleveland and Case Western Reserve University
  • Columbus Children's Hospital
  • Oklahoma University Medical Center
  • CCOP - Columbia River Oncology Program
  • Cancer Institute at Oregon Health and Science University
  • Doernbecher Children's Hospital at Oregon Health & Science University
  • Children's Hospital at Milton S. Hershey Medical Center
  • Children's Hospital of Philadelphia
  • Children's Hospital of Pittsburgh
  • Hollings Cancer Center at Medical University of South Carolina
  • St. Jude Children's Research Hospital
  • Vanderbilt Children's Hospital
  • Simmons Cancer Center at University of Texas Southwestern Medical Center - Dallas
  • Cook Children's Medical Center - Fort Worth
  • Baylor College of Medicine
  • M.D. Anderson Cancer Center at University of Texas
  • University of Texas Health Science Center at San Antonio
  • MBCCOP - South Texas Pediatrics
  • Pediatric Hematology and Oncology Associates of South Texas, PLLC
  • CCOP - Scott and White Hospital
  • Huntsman Cancer Institute at University of Utah
  • INOVA Fairfax Hospital
  • Children's Hospital and Regional Medical Center - Seattle
  • Deaconess Medical Center
  • Madigan Army Medical Center
  • CCOP - St. Vincent Hospital Cancer Center, Green Bay
  • University of Wisconsin Comprehensive Cancer Center
  • CCOP - Marshfield Clinic Research Foundation
  • Midwest Children's Cancer Center
  • Children's Hospital at Westmead
  • Royal Children's Hospital
  • Women's and Children's Hospital
  • Royal Children's Hospital
  • Princess Margaret Hospital for Children
  • Alberta Children's Hospital
  • British Columbia Children's Hospital
  • CancerCare Manitoba
  • Hospital for Sick Children
  • McGill Cancer Centre at McGill University
  • Hopital Sainte Justine
  • Starship Children's Health
  • San Jorge Children's Hospital
  • Swiss Pediatric Oncology Group Bern
  • Swiss Pediatric Oncology Group Lausanne

Outcomes

Primary Outcome Measures

Progression Free Survival

Secondary Outcome Measures

Compare the efficacy of a two-drug regimen
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
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
Determine if whole blood hydroxychloroquine levels correlate with response and toxicity.

Full Information

First Posted
March 8, 2002
Last Updated
February 12, 2014
Sponsor
Children's Oncology Group
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00031824
Brief Title
Hydroxychloroquine in Treating Patients With Newly Diagnosed Chronic Graft-Versus-Host Disease
Official Title
Phase III Trial of Hydroxychloroquine + Standard Therapy for Chronic Graft-Versus-Host Disease
Study Type
Interventional

2. Study Status

Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
April 2002 (undefined)
Primary Completion Date
May 2005 (Actual)
Study Completion Date
January 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Oncology Group
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Graft Versus Host Disease
Keywords
graft versus host disease

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
Double
Allocation
Randomized
Enrollment
82 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
cyclosporine
Intervention Type
Drug
Intervention Name(s)
hydroxychloroquine
Intervention Type
Drug
Intervention Name(s)
prednisone
Intervention Type
Drug
Intervention Name(s)
tacrolimus
Primary Outcome Measure Information:
Title
Progression Free Survival
Time Frame
Length of study
Secondary Outcome Measure Information:
Title
Compare the efficacy of a two-drug regimen
Description
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.
Time Frame
Length of study
Title
Compare conventional outcomes measures
Description
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.
Time Frame
Length of study
Title
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
Title
Determine if whole blood hydroxychloroquine levels correlate with response and toxicity.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
29 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed* newly diagnosed extensive chronic graft-versus-host disease (GVHD) of ≥ 1 organ system (e.g., lip, skin, or liver) documented by all of the following: Clinicopathologic features of GVHD, including involvement of any of the following organ systems: Skin changes Oral changes Hepatic involvement Gastrointestinal involvement Sicca syndrome Pulmonary involvement Myofascial Skeletal Other inflammatory conditions (e.g., myositis, arthritis, polyserositis, or unexplained pericardial, pleural, or peritoneal effusions) Autoantibodies Extent of disease, defined according to the following classification: Limited chronic GVHD, defined by 1 of the following: Localized skin involvement and/or liver dysfunction Involvement of only 1 target organ Extensive chronic GVHD, defined by 1 of the following: Generalized skin involvement of ≥ 50% of body surface area Localized skin involvement and/or liver dysfunction AND ≥ 1 of the following: Liver histology showing chronic aggressive hepatitis, bridging necrosis, or cirrhosis Eye involvement (Schirmer's test with < 5 mm wetting) Involvement of minor salivary glands or oral mucosa on lip biopsy Involvement of any other target organs Involvement of ≥ 2 target organs Timing of onset, including onset of any of the following types: Progressive onset defined as, evolving directly from acute GVHD, commonly with the development of typical manifestations such as oral or skin lichenoid changes or sclerodermatous skin changes Quiescent onset, defined as developing after the resolution of acute GVHD De novo onset, defined as developing with no prior history of acute GVHD Must have ≥ 1 typical clinical manifestation of chronic GVHD that differs from that of acute GVHD (e.g., rash, anorexia, nausea, emesis, diarrhea, abdominal pain, or cholestasis) Symptoms of acute GVHD allowed at the time of diagnosis of chronic GVHD Prior allogeneic bone marrow, peripheral blood stem cell, or cord blood transplantation from a family member or unrelated donor for malignancy required NOTE: *Histologic confirmation may be "consistent with GVHD" PATIENT CHARACTERISTICS: Age: 1 to 29 Performance status: Lansky 50-100% OR Karnofsky 50-100% Life expectancy: At least 2 months Hematopoietic: Absolute neutrophil count ≥ 1,000/mm^3, unless due to chronic GVHD (i.e., autoimmune neutropenia or bone marrow suppression) Hepatic: See Disease Characteristics Renal: Creatinine < 1.5 times upper limit of normal OR Creatinine clearance ≥ 60 mL/min Other: Not pregnant Negative pregnancy test Fertile patients must use effective contraception during and for 3 months after study participation No lysosomal storage disorder No uncontrolled infection (e.g., persistent bacterial, fungal, or viral infection despite appropriate antimicrobial therapy) No G6PD deficiency No history of psoriasis or porphyria No hypersensitivity to 4-aminoquinolines No prior retinal or visual field changes due to 4-aminoquinolines PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics No concurrent daclizumab or infliximab No concurrent thalidomide Chemotherapy: Not specified Endocrine therapy: Prior topical steroids for treatment of extensive chronic GVHD allowed Prior adjustment to prednisone dose allowed if done as a reversal of a taper Prior steroids (prednisone ≤ 1 mg/kg/day (or equivalent) for symptom management for up to 1 week before study entry allowed Concurrent steroids for treatment and/or prophylaxis of acute GVHD allowed if prednisone dose is ≤ 2 mg/kg/day (or equivalent) Concurrent topical steroids allowed Radiotherapy: Not specified Surgery: Not specified Other: No prior treatment for extensive chronic GVHD except the following: Topical treatment (e.g., tacrolimus ointment or pimecrolimus cream) Adjustments of cyclosporine or tacrolimus doses for GVHD prophylaxis or treatment of acute GVHD Concurrent cyclosporine or tacrolimus allowed Cyclosporine must have been started before study entry No other concurrent systemic or topical immunosuppressants, including any of the following: Azathioprine Mycophenolate mofetil Psoralen-ultraviolet light therapy Photopheresis No administration of any of the following for 1 hour before until 2 hours after study drug administration: Antacids Sucralfate Cholestyramine Bicarbonate
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew L. Gilman, MD
Organizational Affiliation
UNC Lineberger Comprehensive Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
Arizona Cancer Center at University of Arizona Health Sciences Center
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Facility Name
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Southern California Permanente Medical Group
City
Downey
State/Province
California
ZIP/Postal Code
90242
Country
United States
Facility Name
City of Hope Comprehensive Cancer Center
City
Duarte
State/Province
California
ZIP/Postal Code
91010-3000
Country
United States
Facility Name
Children's Hospital Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027-0700
Country
United States
Facility Name
University Medical Center at Princeton
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027-0700
Country
United States
Facility Name
Kaiser Permanente Medical Center - Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Facility Name
Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Jonsson Comprehensive Cancer Center at UCLA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095-1781
Country
United States
Facility Name
Children's Hospital and Research Center at Oakland
City
Oakland
State/Province
California
ZIP/Postal Code
94609
Country
United States
Facility Name
Children's Hospital of Orange County
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Lucile Packard Children's Hospital at Stanford University Medical Center
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304-1812
Country
United States
Facility Name
Children's Hospital and Health Center, San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92123-4282
Country
United States
Facility Name
UCSF Comprehensive Cancer Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
Presbyterian - St. Luke's Medical Center
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80907
Country
United States
Facility Name
Children's Hospital Cancer Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Facility Name
Lombardi Cancer Center at Georgetown University Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
Children's National Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010-2970
Country
United States
Facility Name
University of Florida Shands Cancer Center
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610-0296
Country
United States
Facility Name
Nemours Children's Clinic
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32207-8482
Country
United States
Facility Name
Miami Children's Hospital
City
Miami
State/Province
Florida
ZIP/Postal Code
33155-4069
Country
United States
Facility Name
All Children's Hospital
City
St. Petersburg
State/Province
Florida
ZIP/Postal Code
33701
Country
United States
Facility Name
AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Scottish Rite Campus
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
MBCCOP-Medical College of Georgia Cancer Center
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912-4000
Country
United States
Facility Name
Cancer Research Center of Hawaii
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96813
Country
United States
Facility Name
University of Chicago Cancer Research Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60601
Country
United States
Facility Name
Children's Memorial Hospital - Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60614
Country
United States
Facility Name
Riley Children Cancer Center at Riley Hospital for Children
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202-5225
Country
United States
Facility Name
Holden Comprehensive Cancer Center at University of Iowa
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242-1009
Country
United States
Facility Name
Markey Cancer Center at University of Kentucky Chandler Medical Center
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536-0084
Country
United States
Facility Name
Kosair Children's Hospital
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40232
Country
United States
Facility Name
MBCCOP - LSU Health Sciences Center
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Children's Hospital of New Orleans
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70118
Country
United States
Facility Name
Maine Children's Cancer Program
City
Scarborough
State/Province
Maine
ZIP/Postal Code
04074-9308
Country
United States
Facility Name
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Floating Hospital for Children
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
Massachusetts General Hospital Cancer Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114-2696
Country
United States
Facility Name
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
University of Michigan Comprehensive Cancer Center
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109-0914
Country
United States
Facility Name
Children's Hospital of Michigan
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
DeVos Children's Hospital
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Facility Name
Children's Hospitals and Clinics - Minneapolis/St. Paul
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55404
Country
United States
Facility Name
University of Minnesota Cancer Center
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
University of Mississippi Medical Center
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216-4505
Country
United States
Facility Name
Children's Mercy Hospital
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64108
Country
United States
Facility Name
Cardinal Glennon Children's Hospital
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63104
Country
United States
Facility Name
Methodist Cancer Center at Methodist Specialty and Transplant Hospital
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63104
Country
United States
Facility Name
St. Louis Children's Hospital
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
UNMC Eppley Cancer Center at the University of Nebraska Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198-3330
Country
United States
Facility Name
Cancer Center at Hackensack University Medical Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
Schneider Children's Hospital
City
New Hyde Park
State/Province
New York
ZIP/Postal Code
11042
Country
United States
Facility Name
NYU Cancer Institute at New York University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Memorial Sloan-Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Herbert Irving Comprehensive Cancer Center at Columbia University
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
James P. Wilmot Cancer Center at University of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
SUNY Upstate Medical University Hospital
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
New York Medical College
City
Valhalla
State/Province
New York
ZIP/Postal Code
10595
Country
United States
Facility Name
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599-7070
Country
United States
Facility Name
Duke Comprehensive Cancer Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Cincinnati Children's Hospital Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229-3039
Country
United States
Facility Name
Ireland Cancer Center at University Hospitals of Cleveland and Case Western Reserve University
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106-5065
Country
United States
Facility Name
Columbus Children's Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43205-2696
Country
United States
Facility Name
Oklahoma University Medical Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73190
Country
United States
Facility Name
CCOP - Columbia River Oncology Program
City
Portland
State/Province
Oregon
ZIP/Postal Code
97225
Country
United States
Facility Name
Cancer Institute at Oregon Health and Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239-3098
Country
United States
Facility Name
Doernbecher Children's Hospital at Oregon Health & Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239-3098
Country
United States
Facility Name
Children's Hospital at Milton S. Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033-0850
Country
United States
Facility Name
Children's Hospital of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Children's Hospital of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Hollings Cancer Center at Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
St. Jude Children's Research Hospital
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38105
Country
United States
Facility Name
Vanderbilt Children's Hospital
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232-6310
Country
United States
Facility Name
Simmons Cancer Center at University of Texas Southwestern Medical Center - Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390-9063
Country
United States
Facility Name
Cook Children's Medical Center - Fort Worth
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-2399
Country
United States
Facility Name
M.D. Anderson Cancer Center at University of Texas
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-4009
Country
United States
Facility Name
University of Texas Health Science Center at San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78207
Country
United States
Facility Name
MBCCOP - South Texas Pediatrics
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229-3900
Country
United States
Facility Name
Pediatric Hematology and Oncology Associates of South Texas, PLLC
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
CCOP - Scott and White Hospital
City
Temple
State/Province
Texas
ZIP/Postal Code
76508
Country
United States
Facility Name
Huntsman Cancer Institute at University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
Facility Name
INOVA Fairfax Hospital
City
Falls Church
State/Province
Virginia
ZIP/Postal Code
22042-3300
Country
United States
Facility Name
Children's Hospital and Regional Medical Center - Seattle
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
Facility Name
Deaconess Medical Center
City
Spokane
State/Province
Washington
ZIP/Postal Code
99210-0248
Country
United States
Facility Name
Madigan Army Medical Center
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98431-0001
Country
United States
Facility Name
CCOP - St. Vincent Hospital Cancer Center, Green Bay
City
Green Bay
State/Province
Wisconsin
ZIP/Postal Code
54301
Country
United States
Facility Name
University of Wisconsin Comprehensive Cancer Center
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792-4108
Country
United States
Facility Name
CCOP - Marshfield Clinic Research Foundation
City
Marshfield
State/Province
Wisconsin
ZIP/Postal Code
54449
Country
United States
Facility Name
Midwest Children's Cancer Center
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
Children's Hospital at Westmead
City
Westmead
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
Facility Name
Royal Children's Hospital
City
Brisbane
State/Province
Queensland
ZIP/Postal Code
4029
Country
Australia
Facility Name
Women's and Children's Hospital
City
North Adelaide
State/Province
South Australia
ZIP/Postal Code
5006
Country
Australia
Facility Name
Royal Children's Hospital
City
Parkville
State/Province
Victoria
ZIP/Postal Code
3052
Country
Australia
Facility Name
Princess Margaret Hospital for Children
City
Perth
State/Province
Western Australia
ZIP/Postal Code
6001
Country
Australia
Facility Name
Alberta Children's Hospital
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2T 5C7
Country
Canada
Facility Name
British Columbia Children's Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6H 3V4
Country
Canada
Facility Name
CancerCare Manitoba
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3E 0V9
Country
Canada
Facility Name
Hospital for Sick Children
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X8
Country
Canada
Facility Name
McGill Cancer Centre at McGill University
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3H 1P3
Country
Canada
Facility Name
Hopital Sainte Justine
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1C5
Country
Canada
Facility Name
Starship Children's Health
City
Auckland
Country
New Zealand
Facility Name
San Jorge Children's Hospital
City
Santurce
ZIP/Postal Code
00912
Country
Puerto Rico
Facility Name
Swiss Pediatric Oncology Group Bern
City
Bern
ZIP/Postal Code
CH 3010
Country
Switzerland
Facility Name
Swiss Pediatric Oncology Group Lausanne
City
Lausanne
ZIP/Postal Code
CH 1011
Country
Switzerland

12. IPD Sharing Statement

Citations:
PubMed Identifier
21689773
Citation
Gilman AL, Schultz KR, Goldman FD, Sale GE, Krailo MD, Chen Z, Langholz B, Jacobsohn DA, Chan KW, Ryan RE, Kellick M, Neudorf SM, Godder K, Sandler ES, Sahdev I, Grupp SA, Sanders JE, Wall DA. Randomized trial of hydroxychloroquine for newly diagnosed chronic graft-versus-host disease in children: a Children's Oncology Group study. Biol Blood Marrow Transplant. 2012 Jan;18(1):84-91. doi: 10.1016/j.bbmt.2011.05.016. Epub 2011 May 30.
Results Reference
result
PubMed Identifier
21669298
Citation
Rozmus J, Schultz KR, Wynne K, Kariminia A, Satyanarayana P, Krailo M, Grupp SA, Gilman AL, Goldman FD. Early and late extensive chronic graft-versus-host disease in children is characterized by different Th1/Th2 cytokine profiles: findings of the Children's Oncology Group Study ASCT0031. Biol Blood Marrow Transplant. 2011 Dec;17(12):1804-13. doi: 10.1016/j.bbmt.2011.05.011. Epub 2011 May 25.
Results Reference
result
PubMed Identifier
21149333
Citation
Hall MJ, Reid JE, Wenstrup RJ. Prevalence of BRCA1 and BRCA2 mutations in women with breast carcinoma In Situ and referred for genetic testing. Cancer Prev Res (Phila). 2010 Dec;3(12):1579-85. doi: 10.1158/1940-6207.CAPR-09-0218.
Results Reference
result
PubMed Identifier
17925486
Citation
Fujii H, Cuvelier G, She K, Aslanian S, Shimizu H, Kariminia A, Krailo M, Chen Z, McMaster R, Bergman A, Goldman F, Grupp SA, Wall DA, Gilman AL, Schultz KR. Biomarkers in newly diagnosed pediatric-extensive chronic graft-versus-host disease: a report from the Children's Oncology Group. Blood. 2008 Mar 15;111(6):3276-85. doi: 10.1182/blood-2007-08-106286. Epub 2007 Oct 9.
Results Reference
result

Learn more about this trial

Hydroxychloroquine in Treating Patients With Newly Diagnosed Chronic Graft-Versus-Host Disease

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