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CIBMTR Research Database

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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

Study Description
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

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

Study Design
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Study Type : Observational
Estimated Enrollment : 99999999 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Protocol For A Research Database For Hematopoietic Stem Cell Transplantation, Other Cellular Therapies and Marrow Toxic Injuries
Study Start Date : July 2002
Estimated Primary Completion Date : July 2025
Estimated Study Completion Date : July 2025
Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.

  2. 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

  3. 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"


Other Outcome Measures:
  1. 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


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Recipients and Donors that are involved with stem cell transplantation, other cellular therapies, and gene therapies.
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01166009


Contacts
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Contact: Brandan Butler 763 406 3280 databaseIRB@nmdp.org

Locations
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United States, Minnesota
Center for International Blood and Marrow Transplant Research Recruiting
Minneapolis, Minnesota, United States, 55413
Contact: Brandan Butler       DatabaseIRB@NMDP.org   
United States, Wisconsin
Medical College of Wisconsin Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Brandan Butler       DatabaseIRB@nmdp.org   
Sponsors and Collaborators
Center for International Blood and Marrow Transplant Research
Investigators
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Principal Investigator: Patricia Steinert, PhD, MBA Center for International Blood and Marrow Transplant Research
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Center for International Blood and Marrow Transplant Research
ClinicalTrials.gov Identifier: NCT01166009    
Obsolete Identifiers: NCT00923585, NCT01160497, NCT02401009
Other Study ID Numbers: NMDP IRB-1999-0021
First Posted: July 20, 2010    Key Record Dates
Last Update Posted: January 23, 2023
Last Verified: January 2023
Keywords provided by Center for International Blood and Marrow Transplant Research:
Data Collection
CIBMTR
NMDP
 Stem Cell Transplantation
Gene Therapy
CAR-T
Additional relevant MeSH terms:
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Hematologic Neoplasms
Neoplasms by Site
Neoplasms
Hematologic Diseases