Protocol For A Research Database For Hematopoietic Stem Cell Transplantation, Other Cellular Therapies and Marrow Toxic Injuries

• ClinicalTrials.gov Identifier: NCT01166009
• Recruitment Status: Recruiting
• First Posted: July 20, 2010
• Last Update Posted: July 24, 2019
• Sponsor: Center for International Blood and Marrow Transplant Research
• Information provided by (Responsible Party): Center for International Blood and Marrow Transplant Research

Tracking Information

• First Submitted Date: July 16, 2010
• First Posted Date: July 20, 2010
• Last Update Posted Date: July 24, 2019
• Study Start Date: July 2002
• Estimated Primary Completion Date: July 2025 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: July 19, 2010)

A Comprehensive Source of Observational Data to assess Stem Cell Transplant [ Time Frame: Anually - on average ]

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 can be improved
• Long term outcomes after transplantation
• How well donors recover from collection procedure

• Original Primary Outcome Measures: Same as current
• Change History: Complete list of historical versions of study NCT01166009 on ClinicalTrials.gov Archive Site
• Current Secondary Outcome Measures (submitted: July 19, 2010): A Comprehensive Source of Data for Marrow Toxic Injuries [ Time Frame: anually- on average ]
• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Protocol For A Research Database For Hematopoietic Stem Cell Transplantation, Other Cellular Therapies and Marrow Toxic Injuries
• Official Title: Protocol For A Research Database For Hematopoietic Stem Cell Transplantation, Other Cellular Therapies and Marrow Toxic Injuries

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.

• Detailed Description: Not Provided
• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Retrospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Non-Probability Sample
• Study Population: Recipients and Donors that are involved with a stem cell transplantation process.

Condition

• Autologous Stem Cell Transplantation
• Allogeneic Stem Cell Transplantation
• Solid Tumors
• Blood Cancers

• Intervention: Not Provided
• Study Groups/Cohorts: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: July 19, 2010): 99999999
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: July 2025
• Estimated Primary Completion Date: July 2025 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: Child, Adult, Older Adult
• Accepts Healthy Volunteers: No

Contacts

Contact: Kay Gardner; 763 406 3439; kgardner@nmdp.org

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01166009
• Other Study ID Numbers: NMDP IRB-1999-0021
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Center for International Blood and Marrow Transplant Research
• Study Sponsor: Center for International Blood and Marrow Transplant Research
• Collaborators: Not Provided

Investigators

• Principal Investigator: Douglas Rizzo, M.D.,M.S; Center for International Blood and Marrow Transplant Research

• PRS Account: Center for International Blood and Marrow Transplant Research
• Verification Date: July 2019