CIBMTR Research Database

NCT01166009 | Recruiting

• 1 other identifier: NMDP IRB-2002-0063
• Study Type: observational
• Target: 99,999,999
• Locations: 1 country
• Sites: 2

Brief Summary

The primary purpose of the Research Database is to have a comprehensive source of observational data that can be used to study HSC transplantation and cellular therapies. A secondary purpose of the Research Database is to have a comprehensive source of data to study marrow toxic injuries. Objectives: To learn more about what makes stem cell transplants and cellular therapies work well such as:

• Determine how well recipients recover from their transplants or cellular therapy;
• Determine how recovery after a transplant or cellular therapy can be improved;
• Determine how a donor's or recipient's genetics impact recipient recovery after a transplant or cellular therapy;
• Determine how access to transplant or cellular therapy for different groups of patients can be improved;
• Determine how well donors recover from the collection procedures.

Conditions

Autologous Stem Cell Transplantation; Allogeneic Stem Cell Transplantation; Solid Tumors; Blood Cancers; CAR-T; Gene Therapy; Non-malignant Disease

Keywords

Data Collection; CIBMTR; NMDP; Stem Cell Transplantation; Gene Therapy; CAR-T

Outcome Measures

Primary Outcomes (1)

• A Comprehensive Source of Observational Data to assess Stem Cell Transplant

  A primary outcome is to have a comprehensive source of stem cell transplant data that can be used to assess topics such as: * Recipient Recover time * How recovery after transplant and other cellular therapies can be improved * Long term outcomes after transplantation and other cellular therapies * How well donors recover from collection procedure

  Anually - on average

Secondary Outcomes (3)

• A Comprehensive Source of Data for Marrow Toxic Injuries

  anually- on average

• Prospective Assessment of Allogeneic Hematopoietic Cell Transplantation in Patients with Medicare Coverage (17-CMS-SCD)

  annually - on average

• Prospective Assessment of Allogeneic Hematopoietic Cell Transplantation in Patients with Medicare Coverage (10CMSMDS-1)

  annually - on average

Other Outcomes (1)

• Prospective Assessment of Allogeneic Hematopoietic Cell Transplantation in Patients with Medicare Coverage

  annually - on average

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Recipients and Donors that are involved with stem cell transplantation, other cellular therapies, and gene therapies.

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Center for International Blood and Marrow Transplant Research: lead

Study Sites (2)

Center for International Blood and Marrow Transplant Research

Minneapolis, Minnesota, 55413, United States

RECRUITING

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

RECRUITING

Related Publications (1)

• Atallah E, Logan B, Chen M, Cutler C, Deeg J, Jacoby M, Champlin R, Nishihori T, Confer D, Gajewski J, Farnia S, Greenberg P, Warlick E, Weisdorf D, Saber W, Horowitz MM, Rizzo JD. Comparison of Patient Age Groups in Transplantation for Myelodysplastic Syndrome: The Medicare Coverage With Evidence Development Study. JAMA Oncol. 2020 Apr 1;6(4):486-493. doi: 10.1001/jamaoncol.2019.5140.

  PMID: 31830234 DERIVED

MeSH Terms

Conditions

Hematologic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Patricia Steinert, PhD, MBA

  Center for International Blood and Marrow Transplant Research

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Leigh Anne Blackmon

CONTACT

763 406 8087; databaseIRB@nmdp.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2010
• First Posted: July 20, 2010
• Study Start: July 1, 2002
• Primary Completion (Estimated): July 1, 2050
• Study Completion (Estimated): July 1, 2050
• Last Updated: August 12, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)