Immune Mediated Disorders After Allogeneic Hematopoietic Cell Transplantation



Status:Active, not recruiting
Conditions:Bronchitis, Neurology, Orthopedic, Pulmonary, Hematology
Therapuetic Areas:Hematology, Neurology, Pulmonary / Respiratory Diseases, Orthopedics / Podiatry
Healthy:No
Age Range:Any
Updated:4/21/2016
Start Date:March 2011
End Date:September 2016

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Longitudinal Study of Immune Mediated Disorders After Allogeneic Hematopoietic Cell Transplantation (HCT)

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.

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)
We found this trial at
14
sites
St. Louis, Missouri 63110
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666 Elm Street
Buffalo, New York 14263
(716) 845-2300
Roswell Park Cancer Institute Welcome to Roswell Park Cancer Institute (RPCI), America's first cancer center...
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Buffalo, NY
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Chapel Hill, North Carolina 27599
(919) 962-2211
University of North Carolina at Chapel Hill Carolina’s vibrant people and programs attest to the...
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Minneapolis, Minnesota 55455
(612) 625-5000
Univ of Minnesota With a flagship campus in the heart of the Twin Cities, and...
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450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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Boston, MA
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2049 E 100th St
Cleveland, Ohio 44106
(216) 444-2200
Cleveland Clinic Foundation The Cleveland Clinic (formally known as The Cleveland Clinic Foundation) is a...
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281 W. Lane Ave
Columbus, Ohio 43210
(614) 292-6446
Ohio State University The Ohio State University’s main Columbus campus is one of America’s largest...
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8701 W Watertown Plank Rd
Milwaukee, Wisconsin
(414) 955-8296
Medical College of Wisconsin The Medical College (MCW) of Wisconsin is a major national research...
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2201 West End Ave
Nashville, Tennessee 37232
(615) 322-7311
Vanderbilt University Vanderbilt offers undergraduate programs in the liberal arts and sciences, engineering, music, education...
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New York, New York 10021
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Scottsdale, Arizona 85259
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450 Serra Mall
Stanford, California 94305
(650) 723-2300
Stanford University Stanford University, located between San Francisco and San Jose in the heart of...
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Tampa, Florida 33612
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Tampa, FL
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