Vanderbilt-Ingram Cancer Center

Research Question: Of the participants undergoing allogeneic hematopoietic cell transplantation (HCT), can researchers better identify: -who will develop immune-mediated disorders -what types of disorders participants will have -whether these disorders will be severe or respond to currently available therapies- Subjects taking part in this study will be followed for at least 2 years unless they withdraw or are terminated from the study. Standard visits for this study will be as follows: Visit 1 may take place at any time before transplantation up to day 121 post transplant, excluding the 24 hours prior to and immediately after the graft infusion. Visit 1 may occur with Visit 2 if between day 79 and 121 post transplant. Visit 2 must be completed at day 100 - 21 days. Visit 3 must be completed at day 180 - 45 days. Visit 4 must be completed at day 365 - 60 days Visit 5 must be completed at day 730 - 90 days During these study visits, subjects will answer questions about their overall health. Study assessments will include, but are not limited to medical history, a physical exam, review of symptoms, medication review, and specimen collection (urine and blood) for clinical laboratory testing. Research samples will be collected at the site whenever possible. For those subjects who cannot attend face to face visits for visit #3 and #4, a laboratory kit may be supplied to the subject with detailed instructions for use. This study plans to enroll 1118 participants (about 1018 adults, 100 children) over a 3 year period at 9 study sites.

Criteria
 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)