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CIBMTR Research Database

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01166009
Recruitment Status : Recruiting
First Posted : July 20, 2010
Last Update Posted : January 23, 2023
Sponsor:
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 January 23, 2023
Study Start Date July 2002
Estimated Primary Completion Date July 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 20, 2023)		 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 and other cellular therapies can be improved
  • Long term outcomes after transplantation and other cellular therapies
  • How well donors recover from collection procedure
Original 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
Change History
Current Secondary Outcome Measures
 (submitted: March 18, 2022)
  • A Comprehensive Source of Data for Marrow Toxic Injuries [ Time Frame: anually- on average ]
    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.
  • Prospective Assessment of Allogeneic Hematopoietic Cell Transplantation in Patients with Medicare Coverage (17-CMS-SCD) [ Time Frame: annually - on average ]
    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
  • Prospective Assessment of Allogeneic Hematopoietic Cell Transplantation in Patients with Medicare Coverage (10CMSMDS-1) [ Time Frame: annually - on average ]
    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"
Original Secondary Outcome Measures
 (submitted: July 19, 2010)		 A Comprehensive Source of Data for Marrow Toxic Injuries [ Time Frame: anually- on average ]
Current Other Pre-specified Outcome Measures
 (submitted: March 18, 2022)		 Prospective Assessment of Allogeneic Hematopoietic Cell Transplantation in Patients with Medicare Coverage [ Time Frame: annually - on average ]
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
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title CIBMTR Research Database
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 stem cell transplantation, other cellular therapies, and gene therapies.
Condition
  • Autologous Stem Cell Transplantation
  • Allogeneic Stem Cell Transplantation
  • Solid Tumors
  • Blood Cancers
  • CAR-T
  • Gene Therapy
  • Non-malignant Disease
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
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: Brandan Butler 763 406 3280 databaseIRB@nmdp.org
Listed Location Countries United States
Removed Location Countries  
 
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
Current Responsible Party Center for International Blood and Marrow Transplant Research
Original Responsible Party J. Douglas Rizzo, M.D.,M.S, Center for International Blood and Marrow Transplant Research
Current Study Sponsor Center for International Blood and Marrow Transplant Research
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators
Principal Investigator: Patricia Steinert, PhD, MBA Center for International Blood and Marrow Transplant Research
PRS Account Center for International Blood and Marrow Transplant Research
Verification Date January 2023