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Trial record 2 of 4 for:    Research Database for Hematopoietic Stem Cell Transplantation

Protocol for a Research Database for HCT, Other Cellular Therapies and Marrow Toxic Injuries

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ClinicalTrials.gov Identifier: NCT02401009
Recruitment Status : Active, not recruiting
First Posted : March 27, 2015
Last Update Posted : October 25, 2017
Sponsor:
Collaborator:
National Marrow Donor Program
Information provided by (Responsible Party):
Medical College of Wisconsin

Brief Summary:
The primary goal of the CIBMTR Research Program is to improve the safety and effectiveness of hematopoietic cell (HC) transplantation for both donors and recipients.

Condition or disease Intervention/treatment
Hematopoietic Stem Cell Transplantation Other: HCT or other cellular therapies

Detailed Description:

The Research Database contains demographic and clinical data on allogeneic related and unrelated donor and autologous HC transplants. Data are also collected on unrelated donors and their donation experiences. The data contained in the research databases are observational data. The Center for International Blood and Marrow Transplant Research (CIBMTR) does not determine which therapies are used for patients, but rather collects information regarding therapies as they are applied by transplant centers.

Secondary goals of the CIBMTR Research Program are to understand uses of hematopoietic cells for regenerative medicine or immune-based therapy, including for malignancy or infection, and to improve treatments and outcomes for those individuals who have been exposed to radiation or other chemicals that are toxic to marrow. In these cases, exposure data, organ injury data, treatment data, and outcomes data are collected.


Study Type : Observational [Patient Registry]
Actual Enrollment : 390000 participants
Observational Model: Other
Time Perspective: Other
Target Follow-Up Duration: 100 Years
Official Title: Protocol for a Research Database for Hematopoietic Cell Transplantation, Other Cellular Therapies and Marrow Toxic Injuries
Study Start Date : January 1972
Estimated Primary Completion Date : July 2022
Estimated Study Completion Date : July 2022

Group/Cohort Intervention/treatment
HCT, cell therapy, marrow toxic injuries
All recipients of HCT or other cellular therapies, both domestic and international, and marrow toxic injuries reported to the CIBMTR
Other: HCT or other cellular therapies
Hematopoietic stem cell transplantation or other cellular infusion therapy



Primary Outcome Measures :
  1. Hematopoietic stem cell transplants or cellular therapy patient outcomes [ Time Frame: post-transplant or therapy ]

Secondary Outcome Measures :
  1. Long-term outcomes [ Time Frame: post-transplant or therapy ]
  2. Donors recovery from collection procedures [ Time Frame: post-transplant or therapy ]
  3. Long-term effects of exposure to radiation or other chemicals [ Time Frame: post-transplant or therapy ]
  4. Role of transplantation in the management of marrow toxic injuries [ Time Frame: post-transplant or therapy ]
  5. Role of hematopoietic cells for regenerative medicine or immune-based therapy [ Time Frame: post-transplant or therapy ]
  6. Recovery improvement after transplantation or cellular therapy [ Time Frame: post-transplant or therapy ]
  7. Increasing access to transplantation or cellular therapy [ Time Frame: post-transplant or therapy ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Donors and recipients of HCT, recipients of other cellular therapies and individuals with marrow toxic injury
Criteria

Inclusion Criteria:

  • Any recipient of an unrelated or related donor or autologous HC transplant (includes cells collected from peripheral blood, bone marrow or cord blood) or any recipient of cellular therapy 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
  • In the event of a radiation exposure accident, the National Marrow Donor Program (NMDP) has a radiation injury treatment network, whose purpose is to collect data to understand the outcomes of patients treated under these circumstances.
  • Any individual 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.
  • This includes adults with and without decision making capacity, and children.
  • Eligible individuals may have received supportive care only, growth factor support, HC 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.

Exclusion Criteria:


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): NCT02401009


Sponsors and Collaborators
Medical College of Wisconsin
National Marrow Donor Program
Investigators
Principal Investigator: James D Rizzo, MD, MS Medical College of Wisconsin

Responsible Party: Medical College of Wisconsin
ClinicalTrials.gov Identifier: NCT02401009     History of Changes
Other Study ID Numbers: 1166009
First Posted: March 27, 2015    Key Record Dates
Last Update Posted: October 25, 2017
Last Verified: October 2017