Trial Information

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

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.