Trial record 2 of 6 for:    Research Database for Hematopoietic Stem Cell Transplantation

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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Marrow Donor Program
Information provided by (Responsible Party):
Medical College of Wisconsin
ClinicalTrials.gov Identifier:
NCT02401009
First received: March 24, 2015
Last updated: March 21, 2016
Last verified: March 2016
  Purpose
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 Intervention
Hematopoietic Stem Cell Transplantation
Other: HCT or other cellular therapies

Study Type: Observational [Patient Registry]
Target Follow-Up Duration: 100 Years
Official Title: Protocol for a Research Database for Hematopoietic Cell Transplantation, Other Cellular Therapies and Marrow Toxic Injuries

Further study details as provided by Medical College of Wisconsin:

Primary Outcome Measures:
  • Hematopoietic stem cell transplants or cellular therapy patient outcomes [ Time Frame: post-transplant or therapy ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Long-term outcomes [ Time Frame: post-transplant or therapy ] [ Designated as safety issue: No ]
  • Donors recovery from collection procedures [ Time Frame: post-transplant or therapy ] [ Designated as safety issue: No ]
  • Long-term effects of exposure to radiation or other chemicals [ Time Frame: post-transplant or therapy ] [ Designated as safety issue: No ]
  • Role of transplantation in the management of marrow toxic injuries [ Time Frame: post-transplant or therapy ] [ Designated as safety issue: No ]
  • Role of hematopoietic cells for regenerative medicine or immune-based therapy [ Time Frame: post-transplant or therapy ] [ Designated as safety issue: No ]
  • Recovery improvement after transplantation or cellular therapy [ Time Frame: post-transplant or therapy ] [ Designated as safety issue: No ]
  • Increasing access to transplantation or cellular therapy [ Time Frame: post-transplant or therapy ] [ Designated as safety issue: No ]

Enrollment: 390000
Study Start Date: January 1972
Estimated Study Completion Date: July 2017
Estimated Primary Completion Date: July 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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. 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.

  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
Genders Eligible for Study:   Both
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 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:

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02401009

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

Responsible Party: Medical College of Wisconsin
ClinicalTrials.gov Identifier: NCT02401009     History of Changes
Other Study ID Numbers: 1166009 
Study First Received: March 24, 2015
Last Updated: March 21, 2016
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on August 25, 2016