Prospective Cohort for the Evaluation of Biomarkers Following HCT (BMT CTN 1202)

The goal of this protocol is to establish a cohort of biologic samples collected
prospectively from patients treated in BMT CTN centers that will be a shared bio specimen
resource for conducting future allogeneic HCT correlative studies. This resource is designed
to allow genomic, proteomic and transcriptional data to be integrated with high quality
clinical phenotype and outcomes data to identify risk factors for development and severity of
acute GVHD, chronic GVHD, organ toxicity, relapse, mortality, infection and other clinically
significant complications occurring after allogeneic HCT.

To achieve this goal, patients and donors will be recruited and consent obtained at the time
that they enroll on BMT CTN protocols where enrollment occurs at or before transplantation or
prior to start of conditioning for patients enrolled on non-BMT CTN studies or treated as
standard of care. Samples will be collected: (1) from patients and donors pre-transplant;
and, (2) from patients post-transplant on a calendar schedule through the first 3 months
post-HCT. For patients co-enrolled on BMT CTN studies, clinical data will be collected in the
context of the primary transplant protocols. For patients not enrolled on BMT CTN protocols,
clinical data on early post-transplant events will be collected using the same data
collection forms and systems that are used on BMT CTN trials. Additional clinical data for
both BMT CTN and non-BMT CTN patients will be available from data submitted to the Center for
International Blood and Marrow Transplant Research (CIBMTR) using the CIBMTR Comprehensive
Report Forms. This protocol also leverages ongoing pre-transplant donor-recipient sample
collection performed by the CIBMTR and National Marrow Donor Program (NMDP). Success in
establishing this shared resource will inspire future investigator initiated research
proposals and will allow investigators to take advantage of National Institutes of Health
(NIH) funding initiatives.

Inclusion Criteria:

1. Recipients of first allogeneic hematopoietic cell transplants that are transplanted in
U.S. centers that participate in the NMDP/CIBMTR's "Protocol for a Research Sample
Repository for Allogeneic Hematopoietic Stem Cell Transplantation and Marrow Toxic
Injuries" and receive a cord blood graft or receive a bone marrow or peripheral blood
graft from a related donor or from an unrelated donor in an NMDP-affiliated Donor
Center or Registry participating in that same protocol.

This transplant and donor center restriction is to allow linkage with pretransplant
donor specimens collected under the NMDP/CIBMTR protocol. Current data indicate that
>90% of donors approached under this protocol agree to provide samples

2. Patients with any malignant or non-malignant hematologic disorder will be eligible for
enrollment on this protocol. A subset of 240 sequential patients with acute leukemia
in first or second remission will also provide research samples for gene expression
studies.

3. Children may participate in this study but must weigh at least 20 kilograms given the
volume (100ml) and number of blood draws during this study. Subjects must weigh at
least 30 kg to provide research samples for gene expression studies (additional 40
ml).

4. All participants or parent/legal guardian must sign an informed consent for this
study.

Because studies using this resource will require linking with clinical data collected by
CIBMTR, all participants or parent/legal guardian must also consent to participate in
"Protocol for a Research Database for Hematopoietic Cell Transplantation and Marrow Toxic
Injuries".

Exclusion Criteria: