Overview

This trial is active, not recruiting.

Condition hematopoietic stem cell transplantation
Treatment hct or other cellular therapies
Sponsor Medical College of Wisconsin
Collaborator National Marrow Donor Program
Start date January 1972
End date July 2017
Trial size 390000 participants
Trial identifier NCT02401009, 1166009

Summary

The primary goal of the CIBMTR Research Program is to improve the safety and effectiveness of hematopoietic cell (HC) transplantation for both donors and recipients.

United States No locations recruiting
Other Countries No locations recruiting

Primary Outcomes

Measure
Hematopoietic stem cell transplants or cellular therapy patient outcomes
time frame: post-transplant or therapy

Secondary Outcomes

Measure
Long-term outcomes
time frame: post-transplant or therapy
Donors recovery from collection procedures
time frame: post-transplant or therapy
Long-term effects of exposure to radiation or other chemicals
time frame: post-transplant or therapy
Role of transplantation in the management of marrow toxic injuries
time frame: post-transplant or therapy
Role of hematopoietic cells for regenerative medicine or immune-based therapy
time frame: post-transplant or therapy
Recovery improvement after transplantation or cellular therapy
time frame: post-transplant or therapy
Increasing access to transplantation or cellular therapy
time frame: post-transplant or therapy

Eligibility Criteria

Male or female participants of any age.

Inclusion Criteria: - Any recipient of an unrelated or related donor or autologous HC transplant (includes cells collected from peripheral blood, bone marrow or cord blood) or any recipient of cellular therapy 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 - 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 individual 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 individuals 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 who have been requested to donate a product for a recipient are eligible to participate in the Research Database. Exclusion Criteria:

Additional Information

Official title Protocol for a Research Database for Hematopoietic Cell Transplantation, Other Cellular Therapies and Marrow Toxic Injuries
Principal investigator James D Rizzo, MD, MS
Description The Research Database contains demographic and clinical data on allogeneic related and unrelated donor and autologous HC transplants. Data are also collected on unrelated donors and their donation experiences. The data contained in the research databases are observational data. CIBMTR does not determine which therapies are used for patients, but rather collects information regarding therapies as they are applied by transplant centers. Secondary goals of the CIBMTR Research Program are to understand uses of hematopoietic cells for regenerative medicine or immune-based therapy, including for malignancy or infection, and to improve treatments and outcomes for those individuals who have been exposed to radiation or other chemicals that are toxic to marrow. In these cases, exposure data, organ injury data, treatment data, and outcomes data are collected.
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by Medical College of Wisconsin.