Allogeneic Hematopoietic Stem Cell Transplantation Clinical Trial
Official title:
Prospective Multi-Center Cohort for the Evaluation of Biomarkers Predicting Risk of Complications and Mortality Following Allogeneic HCT (BMT CTN #1202)
Verified date | December 2022 |
Source | Medical College of Wisconsin |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
The goal of this protocol is to establish a cohort of at least 1500 biologic samples collected prospectively from patients treated in BMT CTN centers that will be a shared bio specimen resource for conducting future allogeneic hematopoietic stem cell transplantation (HCT) correlative studies.
Status | Completed |
Enrollment | 1860 |
Est. completion date | September 2016 |
Est. primary completion date | September 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility | Inclusion Criteria: 1. Recipients of first allogeneic hematopoietic cell transplants that are transplanted in U.S. centers that participate in the NMDP/CIBMTR's "Protocol for a Research Sample Repository for Allogeneic Hematopoietic Stem Cell Transplantation and Marrow Toxic Injuries" and receive a cord blood graft or receive a bone marrow or peripheral blood graft from a related donor or from an unrelated donor in an NMDP-affiliated Donor Center or Registry participating in that same protocol. This transplant and donor center restriction is to allow linkage with pretransplant donor specimens collected under the NMDP/CIBMTR protocol. Current data indicate that >90% of donors approached under this protocol agree to provide samples 2. Patients with any malignant or non-malignant hematologic disorder will be eligible for enrollment on this protocol. A subset of 240 sequential patients with acute leukemia in first or second remission will also provide research samples for gene expression studies. 3. Children may participate in this study but must weigh at least 20 kilograms given the volume (100ml) and number of blood draws during this study. Subjects must weigh at least 30 kg to provide research samples for gene expression studies (additional 40 ml). 4. All participants or parent/legal guardian must sign an informed consent for this study. Because studies using this resource will require linking with clinical data collected by CIBMTR, all participants or parent/legal guardian must also consent to participate in "Protocol for a Research Database for Hematopoietic Cell Transplantation and Marrow Toxic Injuries". Exclusion Criteria: - N/A |
Country | Name | City | State |
---|---|---|---|
United States | University of Michigan Medical Center | Ann Arbor | Michigan |
United States | BMT at Northside Hospital | Atlanta | Georgia |
United States | Children's Healthcare of Atlanta | Atlanta | Georgia |
United States | Emory University | Atlanta | Georgia |
United States | Johns Hopkins | Baltimore | Maryland |
United States | DFCI/Brigham & Women's | Boston | Massachusetts |
United States | Roswell Park | Buffalo | New York |
United States | University of North Carolina Hospital at Chapel Hill | Chapel Hill | North Carolina |
United States | Ann and Robert H. Lurie Children's Hospital | Chicago | Illinois |
United States | Cleveland Clinic Foundation | Cleveland | Ohio |
United States | University Hospitals of Cleveland/Case Western | Cleveland | Ohio |
United States | Ohio State/Arthur G. James Cancer Hospital | Columbus | Ohio |
United States | Children's Medical Center of Dallas | Dallas | Texas |
United States | City of Hope National Medical Center | Duarte | California |
United States | Duke University | Durham | North Carolina |
United States | Cook Children's Hospital | Fort Worth | Texas |
United States | University of Florida College of Medicine (Shands) | Gainesville | Florida |
United States | Hackensack University Medical Center | Hackensack | New Jersey |
United States | Baylor College of Medicine/The Methodist Hospital | Houston | Texas |
United States | University of Texas/MD Anderson CRC | Houston | Texas |
United States | University of Kansas Hospital | Kansas City | Kansas |
United States | University of Minnesota | Minneapolis | Minnesota |
United States | Memorial Sloan-Kettering Cancer Center | New York | New York |
United States | Mount Sinai Medical Center | New York | New York |
United States | Children's Hospital at Oakland | Oakland | California |
United States | University of Nebraska Medical Center | Omaha | Nebraska |
United States | University of Pennsylvania Cancer Center | Philadelphia | Pennsylvania |
United States | Phoenix Children's Hospital | Phoenix | Arizona |
United States | Oregon Health & Science University | Portland | Oregon |
United States | Virginia Commonwealth University | Richmond | Virginia |
United States | Mayo Clinic - Rochester | Rochester | Minnesota |
United States | Washington University/Barnes Jewish Hospital | Saint Louis | Missouri |
United States | Washington University/St. Louis Children's Hospital | Saint Louis | Missouri |
United States | All Children's Hospital | Saint Petersburg | Florida |
United States | Utah BMT/Primary Children's Medical Center | Salt Lake City | Utah |
United States | Texas Transplant Institute | San Antonio | Texas |
United States | University of CA, SF | San Francisco | California |
United States | Fred Hutchinson Cancer Research Center | Seattle | Washington |
United States | Stanford Hospitals and Clinics | Stanford | California |
United States | H. Lee Moffitt Cancer Center | Tampa | Florida |
United States | Children's National Medical Center | Washington | District of Columbia |
United States | Nemours/Alfred I. duPont Hospital for Children | Wilmington | Delaware |
Lead Sponsor | Collaborator |
---|---|
Medical College of Wisconsin | Blood and Marrow Transplant Clinical Trials Network, National Cancer Institute (NCI), National Heart, Lung, and Blood Institute (NHLBI), National Marrow Donor Program |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Participants Providing Biologic Samples | The primary outcome will be measured by the number of participants who supply biologic samples. The prospectively collected samples will be a shared bio specimen resource for conducting future correlative studies. | Two years from hematopoietic stem cell transplant |
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