Trial Information

Autologous and Related Allogeneic Hematopoietic Stem Cell Transplant Data Submission to the Center for International Blood and Marrow Transplant Research (CIBMTR) and the National Marrow Donor Program (NMDP)

Background:

- In 2005, the United States Congress legislated that outcome data would be collected on
all patients who have been recipients of a stem cell therapeutics product (including
bone marrow, cord blood, or other such product) from a donor. The Health Services and
Resources Administration (HRSA) awarded the contract for this Stem Cell Therapeutic
Outcomes Database (SCTOD) to the Center for International Blood and Marrow
Transplantation (CIBMTR). The CIBMTR is thus responsible for the administration of this
activity and collection and analysis of the data. The CIBMTR was established in 2004 as
an affiliation between the National Marrow Donor Program (NMDP) and the Medical College
of Wisconsin.

- NCI - ETIB and POB, in order to comply with the SCTOD requirements, will participate in
the CIBMTR Outcomes Data Reporting process for all autologous and related allogeneic
hematopoietic cell therapy recipients and donors. Patients receiving unrelated donor
cell therapies will participate in a separate data collection protocol designed to
satisfy the requirements for participation as an NMDP transplant center as well as the
SCTOD reporting.

Objectives:

- To meet the reporting requirements of the Stem Cell Therapeutic Outcomes Database.

Eligibility:

- All patients receiving autologous or related allogeneic hematopoietic stem cell
transplants will be eligible regardless of age, diagnosis, or disease status.

Design and Modifications from CIBMTR protocol:

- Patients will be consented prior to the start of their pre-transplant conditioning
regimen.

- Related donors will be consented prior to the start of their mobilization or, if no
mobilization, prior to the date of cell collection.

- Patients and donors who do not wish to participate will still have a minimum set of
data submitted, as required by law. However, this data will not be used in research.

- For privacy concerns, the following data will not be collected or reported: Social
Security Number (SSN), Mother's Maiden Name, Country of birth, Median household income,
Education and Occupation. This data may be omitted without affecting compliance with
the SCTOD. All other demographic data collected at NIH will be stored separate from the
research records in a locked cabinet accessible only to those with roles directly
related to reporting the data.