Protocol Number: 09-C-0053

Title:

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)

Number:

09-C-0053

Summary:

Background:

- A federal government mandate requires stem cell transplant centers to collect and maintain in a database a minimum of information regarding transplant recipients and their donors.

- The National Marrow Donor Program (NMDP) and the Center for International Blood and Marrow Transplant Research (CIBMTR) maintain an extensive database of medical information on transplant donors and recipients and conducts research using this information.

- Information collected under this study will be submitted to NMDP/CIBMTR in response to the federal mandate.

Objectives:

- To learn more about what makes stem cell transplants work well, such as determining the following:

-how well recipients recover from their transplant

-how recovery after a transplant can be improved

-how access to transplant for different groups of patients can be improved

-how well donors recover from the collection procedures

Eligibility:

- Patients enrolled in an NIH stem cell transplant protocol.

Design:

- Patients are asked to give informed consent to participate in the study before starting pre-transplant conditioning.

- Donors are asked to give informed consent to participate before starting preparation for stem cell collection begins.

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

Sponsoring Institute:

National Cancer Institute (NCI)

Recruitment Detail

Type: Participants currently recruited/enrolled

Gender: Male & Female

Referral Letter Required: Yes

Population Exclusion(s): None

Eligibility Criteria:

Eligibility to Participate in the Research Database

Recipient Eligibility Criteria:

Any recipient of an unrelated or related donor or autologous HSC transplant in a CIBMTR center is eligible to participate in the Research Database. This includes adults with and without decision making capacity, and children.

Individual with Marrow Toxic Injury Eligibility Criteria:

Any individual who is treated for a marrow toxic injury at a center participating in the NMDP's Radiation Injury Transplant Network (RITN) is eligible to participate in the Research Database. This includes adults with and without decision making capacity, and children. Eligible individuals may have received supportive care only, growth factor support, HSC transplant or other appropriate medical treatment for marrow toxic injury. Treatments applied are at the discretion of the care facility, and are not determined by the NMDP or CIBMTR.

Unrelated Donor Eligibility Criteria:

All donors registered on the NMDP Registry who have been requested to donate a product for a recipient are eligible to participate in the Research Database.

All maternal cord blood donors are enrolled in the NMDP Cord Blood Bank Investigational New Drug (IND) protocol, and sign an informed consent document specific to that protocol. Data collected as part of the Cord Blood Bank protocol are included in the Research Database.

Special Instructions:

Currently Not Provided

Keywords:

Data Collection

CIBMTR

NMDP

Stem Cell Transplantation

Recruitment Keyword(s):

None

Condition(s):

Autologous Stem Cell Transplantation

Allogeneic Stem Cell Transplantation

Solid Tumors

Blood Cancers

Investigational Drug(s):

None

Investigational Device(s):

None

Intervention(s):

None

Supporting Site:

National Cancer Institute

Contact(s):

NCI Referral Office
National Institute of Health Clinical Center (CC), 9000 Rockville Pike, Bethesda, Maryland 20892, United States: NCI Clinical Trials Referral Office
Phone: 1-888-NCI-1937
Fax: Not Listed
Electronic Address: ncicssc@mail.nih.gov

Citation(s): Not Provided

• Questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.
• Technical questions regarding the Clinical Center web site, please contact the Department of Clinical Research Informatics, CC.

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