Clinical Evaluations and Laboratory Studies in Patients With Chronic Graft-Versus-Host Disease Who Have Undergone a Previous Donor Stem Cell Transplant

OBJECTIVES:

- Establish a multidisciplinary clinic infrastructure for studying pathogenesis and the
natural history of chronic graft-vs-host disease (cGVHD).

- Determine candidate markers for clinical and biological prognostic factors in patients
with cGVHD after allogeneic hematopoietic stem cell transplantation.

- Develop a prognostic model using patient survival and being permanently off
immunosuppressive drugs for ≥ 3 months 2 years after study entry as the primary
endpoint.

- Develop clinically relevant cGVHD grading scales.

- Determine novel biological characteristics of cGVHD and describe them in the context of
clinical history and presentation.

- Determine potential clinical and biological markers of cGVHD activity.

- Improve current understanding of the biology of cGVHD-associated graft-vs-tumor
effects.

OUTLINE: This is a prospective, natural history, retrospective, longitudinal data collection
study.

Patients referred for evaluation of chronic graft-vs-host disease (cGVHD) undergo a clinical
and laboratory multispecialty diagnostic evaluation that includes blood collection and
biopsies. A summary of the multidisciplinary evaluation and recommendations are conveyed to
the patient and primary physician. Selected clinical outcomes data is collected from
patients by telephone and mail (i.e., interviews and questionnaires) every 6 months for 3
years and then annually for up to 10 years if chronic GVHD is confirmed or cannot be ruled
out.

Patients may undergo additional blood collection and tissue biopsies periodically for
biomarker correlative studies.

PROJECTED ACCRUAL: A total of 290 patients will be accrued for this study.