Protocol Details
Autologous and Related/Unrelated Allogeneic Hematopoietic Stem Cell Transplant and Cellular Therapies Data Submission and Research Sample Collection to the Center for International Blood and Marrow Transplant Research (CIBMTR) and the National Marrow Donor Program (NMDP)
This study is currently recruiting participants.
Summary
Number | 09-C-0053 |
Sponsoring Institute | National Cancer Institute (NCI) |
Recruitment Detail | Type: Enrolling by Invitation
Gender: Male & Female
Min Age: 1 Years
Max Age: N/A |
Referral Letter Required | Yes |
Population Exclusion(s) | Pregnant Women |
Keywords | Cord Blood;
Mobilization;
Allogeneic Hematopoietic;
Stem Cell Therapeutic Outcome;
Demographic Data;
Natural History |
Recruitment Keyword(s) | None |
Condition(s) | Leukemia;
Neoplasms;
Autologous Stem Cell Transplantation;
Hematopoietic Stem Cell Transplantation;
Lymphoma |
Investigational Drug(s) | None |
Investigational Device(s) | None |
Intervention(s) | None |
Supporting Site | National Cancer Institute |
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:
- All participants (recipients and their related/unrelated donors) enrolled in an NIH stem cell transplant protocol.
Design:
- Recipients who do not wish to participate and their donors will still have a minimum set of data submitted, as required by law, but the information obtained will not be used in research.
Eligibility
Eligibility to Participate in the Research Database
Patient Eligibility Criteria:
Any recipient of an unrelated or related allogeneic or autologous HC transplant or cellular therapy whose treatment takes place in a center participating in the CIBMTR is eligible to enroll in the Research Database. This includes adults with and without decision making capacity and children.
Patients with Marrow Toxic Injury Eligibility Criteria:
In the event of a radiation exposure accident, the NMDP has a radiation injury treatment network, whose purpose is to collect data to understand the outcomes of patients treated under these circumstances. Any patient who is treated for a marrow toxic injury at a center participating in the NMDP s Radiation Injury Treatment Network (RITN) is eligible to participate in the Research Database. This includes adults with and without decision making capacity, and children. Eligible patients may have received supportive care only, growth factor support, HC 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 regardless of whether they have been requested to donate a product for a patient, are eligible to participate in the Research Database.
Citations:
Not Provided
Contacts:
Clinical Trials Number:
NCT01166009