CIBMTR Research Database

Solid Tumors Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01166009
• Other study ID #: NMDP IRB-1999-0021
• Status: Recruiting
• Start date: July 2002
• Est. completion date: July 2030

Study information

• Verified date: February 2024
• Source: Center for International Blood and Marrow Transplant Research
• Contact: Brandan Butler
• Phone: 763 406 3280
• Email: databaseIRB[@]nmdp.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Other known NCT identifiers

• NCT00923585
• NCT01160497
• NCT02401009

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 99999999
• Est. completion date: July 2030
• Est. primary completion date: July 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
United States	Medical College of Wisconsin	Milwaukee	Wisconsin
United States	Center for International Blood and Marrow Transplant Research	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Center for International Blood and Marrow Transplant Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Prospective Assessment of Allogeneic Hematopoietic Cell Transplantation in Patients with Medicare Coverage	This study is the main protocol for the following two sub studies. Details for these sub-studies are found under separate NCT numbers.; Multiple Myeloma Medicare Study (NCT03127761): 17-CMS-MM; Myelofibrosis Medicare Study (NCT02934477): 16-CMS-MF	annually - on average
Primary	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	A Comprehensive Source of Data for Marrow Toxic Injuries	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.	anually- on average
Secondary	Prospective Assessment of Allogeneic Hematopoietic Cell Transplantation in Patients with Medicare Coverage (17-CMS-SCD)	This protocol supports data collection for a sub study titled 17-CMS-SCD, an observational study to compare survival of patients 15 to 50 years of age with sickle cell disease who receive allogeneic transplantation compared to those receiving standard of care treatments.; To provide a mechanism to Medicare Beneficiaries with sickle cell disease for claims coverage for allogenic hematopoietic cell transplant.; To provide data requested by Medicare under its coverage with evidence development (CED) process to make payment on claims for HCT using the existing research observational database for the CIBMTR	annually - on average
Secondary	Prospective Assessment of Allogeneic Hematopoietic Cell Transplantation in Patients with Medicare Coverage (10CMSMDS-1)	This protocol supports data collection for a sub-study titled 10-CMSMDS-1 with objective to prospectively examine outcomes of allogenic hematopoietic cell transplant in adults >= 65 years of age with myelodysplastic syndrome to determine whether their outcomes are similar to those in younger patients.; To provide a mechanism for Medicare Beneficiaries with myelodysplastic syndrome for claims coverage for allogenic hematopoietic cell transplant; To provide data requested by Medicare under its CED to make payment on claims for HCT using the existing research observational database of the CIBMTR"	annually - on average