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NCT Number: NCT01166009

CIBMTR Research Database

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.

Recruiting

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Key information

Conditions

Autologous Stem Cell Transplantation Allogeneic Stem Cell Transplantation Blood Cancers CAR-T Gene Therapy Hematologic Diseases Hematologic Neoplasms Hemic and Lymphatic Diseases Neoplasms Neoplasms by Site Non-malignant Disease Solid Tumors

Sex eligibility

All sexes

Study type

Observational

Primary location

Center for International Blood and Marrow Transplant Research, Minneapolis, Minnesota, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  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 outcomes

  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 outcomes

  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

Study contacts

Contact information is provided by the study sponsor or research team.

Leigh Anne Blackmon

CONTACT

[email protected]

763 406 8087

Sponsors and collaborators

Lead sponsor

Center for International Blood and Marrow Transplant Research

Network

Registry information

Official study title

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

Important dates

Study start
2002
Primary completion
2050
Study completion
2050
First posted
Jul 20, 2010
Registry last updated
Aug 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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