Graft vs Host Disease Clinical Trial
Official title:
Longitudinal Study of Immune Mediated Disorders After Allogeneic Hematopoietic Cell Transplantation (HCT)
Verified date | October 2016 |
Source | Fred Hutchinson Cancer Research Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Observational |
The purpose of this research study is to better understand the onset and course of graft versus host disease (GVHD)and other immune-mediated disorders after stem cell transplant.
Status | Completed |
Enrollment | 911 |
Est. completion date | October 2016 |
Est. primary completion date | October 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - Planned or completed first allogeneic stem cell transplant (any conditioning regimen, graft source, donor type and GVHD prophylaxis regimen) - Signed, informed consent and, if applicable, child assent Exclusion Criteria: - Inability to comply with study procedures - Anticipated survival less than 6 months due to co-morbid disease - Autoimmune disorder or inherited immunodeficiency before HCT - Diagnosis of late acute or chronic GVHD prior to study enrollment - Hematologic relapse or chemotherapy refractory disease at restaging within 1 month of HCT or at the time of enrollment (e.g., > 5% blasts for leukemia; poorly responsive lymphoma) |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
United States | Dana Farber Cancer Institute | Boston | Massachusetts |
United States | Roswell Park Cancer Institute | Buffalo | New York |
United States | University of North Carolina at Chapel Hill | Chapel Hill | North Carolina |
United States | Cleveland Clinic Foundation | Cleveland | Ohio |
United States | The Ohio State University | Columbus | Ohio |
United States | Medical College of Wisconsin | Milwaukee | Wisconsin |
United States | University of Minnesota | Minneapolis | Minnesota |
United States | Vanderbilt University | Nashville | Tennessee |
United States | Weill Cornell Medical College | New York | New York |
United States | Mayo Clinic | Scottsdale | Arizona |
United States | Fred Hutchinson Cancer Research Center/Seattle Cancer Care Alliance | Seattle | Washington |
United States | Washington University St. Louis | St. Louis | Missouri |
United States | Stanford University | Stanford | California |
United States | H. Lee Moffitt Cancer Center | Tampa | Florida |
Lead Sponsor | Collaborator |
---|---|
Fred Hutchinson Cancer Research Center | National Cancer Institute (NCI) |
United States,
Filipovich AH, Weisdorf D, Pavletic S, Socie G, Wingard JR, Lee SJ, Martin P, Chien J, Przepiorka D, Couriel D, Cowen EW, Dinndorf P, Farrell A, Hartzman R, Henslee-Downey J, Jacobsohn D, McDonald G, Mittleman B, Rizzo JD, Robinson M, Schubert M, Schultz K, Shulman H, Turner M, Vogelsang G, Flowers ME. National Institutes of Health consensus development project on criteria for clinical trials in chronic graft-versus-host disease: I. Diagnosis and staging working group report. Biol Blood Marrow Transplant. 2005 Dec;11(12):945-56. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The prevalence of immune mediated disorders | The prevalence of: Persistent, recurrent or late onset acute GVHD Cutaneous Sclerosis Bronchiolitis Obliterans Syndrome Chronic GVHD |
Diagnosis of IMD and at 2 years | No |
Secondary | Banked blood and urine samples | Summarized as the percentage of compliance for each center and for the study as a whole | At 2 years | No |
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