Clinical trial NCT01166009: CIBMTR Research Database
Official title: Protocol for a Research Database for Hematopoietic Stem Cell Transplantation, Other Cellular Therapies and Marrow Toxic Injuries
Study type: OBSERVATIONAL
Overall status: RECRUITING
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
Lead sponsor: Center for International Blood and Marrow Transplant Research
Sponsor class: NETWORK
First posted: 2010-07-20
Enrollment: 99999999
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Recipients and Donors that are involved with stem cell transplantation, other cellular therapies, and gene therapies.

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.


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.

Primary outcomes:
measure: A Comprehensive Source of Observational Data to assess Stem Cell Transplant
timeFrame: Anually - on average
Secondary outcomes:
measure: A Comprehensive Source of Data for Marrow Toxic Injuries
timeFrame: anually- on average
measure: Prospective Assessment of Allogeneic Hematopoietic Cell Transplantation in Patients with Medicare Coverage (17-CMS-SCD)
timeFrame: annually - on average
measure: Prospective Assessment of Allogeneic Hematopoietic Cell Transplantation in Patients with Medicare Coverage (10CMSMDS-1)
timeFrame: annually - on average
Other outcomes:
measure: Prospective Assessment of Allogeneic Hematopoietic Cell Transplantation in Patients with Medicare Coverage
timeFrame: annually - on average
Locations:
city: Minneapolis
country: United States
facility: Center for International Blood and Marrow Transplant Research
state: Minnesota
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
Study officials:
affiliation: Center for International Blood and Marrow Transplant Research
name: Patricia Steinert, PhD, MBA
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.