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.
Allogeneic hematopoietic cell transplantation (HCT) is the only known curative option for many hematologic disorders. After transplantation, many patients develop immune mediated disorders that may be life-threatening such as graft versus host disease (GVHD). The morbidity and mortality associated with HCT-associated immune mediated disorders are major barriers to successful use of transplantation to cure rare hematologic malignancies such as leukemia, lymphoma, multiple myeloma, myelodysplastic/myeloproliferative syndromes amongst other diseases. With this study, the investigators will investigate the biologic basis for immune mediated disorders after allogeneic HCT, focusing on those developing cutaneous sclerosis, bronchiolitis obliterans syndrome, late acute GVHD and chronic GVHD. The study will enroll 1118 (1018 adults and 100 children) allogeneic HCT patients over a three year period. Subjects will be followed for two years and monitored closely for development of immune mediated disorders. This study will have 5 study visits at day 1, 100, 180, 365, and 730. During these visits, a physical assessment, medication review, blood and urine collection will occur. If a subject develops an immune mediated disordered, they will be monitored at 3 months, 6 months, 1 year and then annually from the date of diagnosis. During these study visits, a physical assessment, IMD status, and medication review as well as blood and urine collection will occur.
Study Type
OBSERVATIONAL
Enrollment
911
Mayo Clinic
Scottsdale, Arizona, United States
Stanford University
Stanford, California, United States
H. Lee Moffitt Cancer Center
Tampa, Florida, United States
The prevalence of immune mediated disorders
The prevalence of: * Persistent, recurrent or late onset acute GVHD * Cutaneous Sclerosis * Bronchiolitis Obliterans Syndrome * Chronic GVHD
Time frame: Diagnosis of IMD and at 2 years
Banked blood and urine samples
Summarized as the percentage of compliance for each center and for the study as a whole
Time frame: At 2 years
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Dana Farber Cancer Institute
Boston, Massachusetts, United States
University of Minnesota
Minneapolis, Minnesota, United States
Washington University St. Louis
St Louis, Missouri, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
Weill Cornell Medical College
New York, New York, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
...and 4 more locations