Prospective Cohort for the Evaluation of Biomarkers Following HCT (BMT CTN 1202)

Completed

Conditions: Allogeneic Hematopoietic Stem Cell Transplantation

Registration Number: NCT01879072

Lead Sponsor: Medical College of Wisconsin

Brief Summary: 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.

Detailed Description: The goal of this protocol is to establish a cohort of biologic samples collected prospectively from patients treated in BMT CTN centers that will be a shared bio specimen resource for conducting future allogeneic HCT correlative studies. This resource is designed to allow genomic, proteomic and transcriptional data to be integrated with high quality clinical phenotype and outcomes data to identify risk factors for development and severity of acute GVHD, chronic GVHD, organ toxicity, relapse, mortality, infection and other clinically significant complications occurring after allogeneic HCT.

To achieve this goal, patients and donors will be recruited and consent obtained at the time that they enroll on BMT CTN protocols where enrollment occurs at or before transplantation or prior to start of conditioning for patients enrolled on non-BMT CTN studies or treated as standard of care. Samples will be collected: (1) from patients and donors pre-transplant; and, (2) from patients post-transplant on a calendar schedule through the first 3 months post-HCT. For patients co-enrolled on BMT CTN studies, clinical data will be collected in the context of the primary transplant protocols. For patients not enrolled on BMT CTN protocols, clinical data on early post-transplant events will be collected using the same data collection forms and systems that are used on BMT CTN trials. Additional clinical data for both BMT CTN and non-BMT CTN patients will be available from data submitted to the Center for International Blood and Marrow Transplant Research (CIBMTR) using the CIBMTR Comprehensive Report Forms. This protocol also leverages ongoing pre-transplant donor-recipient sample collection performed by the CIBMTR and National Marrow Donor Program (NMDP). Success in establishing this shared resource will inspire future investigator initiated research proposals and will allow investigators to take advantage of National Institutes of Health (NIH) funding initiatives.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 1860

Inclusion Criteria

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
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.
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).
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

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of Participants Providing Biologic Samples	Two years from hematopoietic stem cell transplant	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.

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (42): Ohio State/Arthur G. James Cancer Hospital
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Columbus, Ohio, United States
University of Pennsylvania Cancer Center
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Philadelphia, Pennsylvania, United States
Children's Medical Center of Dallas
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Dallas, Texas, United States
University Hospitals of Cleveland/Case Western
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Cleveland, Ohio, United States
Cleveland Clinic Foundation
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Cleveland, Ohio, United States
Baylor College of Medicine/The Methodist Hospital
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Houston, Texas, United States
University of Texas/MD Anderson CRC
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Houston, Texas, United States
Fred Hutchinson Cancer Research Center
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Seattle, Washington, United States
University of Minnesota
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Minneapolis, Minnesota, United States
Duke University
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Durham, North Carolina, United States
Texas Transplant Institute
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San Antonio, Texas, United States
Phoenix Children's Hospital
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Phoenix, Arizona, United States
Utah BMT/Primary Children's Medical Center
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Salt Lake City, Utah, United States
University of CA, SF
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San Francisco, California, United States
University of Nebraska Medical Center
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Omaha, Nebraska, United States
Oregon Health & Science University
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Portland, Oregon, United States
City of Hope National Medical Center
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Duarte, California, United States
Children's Hospital at Oakland
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Oakland, California, United States
Stanford Hospitals and Clinics
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Stanford, California, United States
Nemours/Alfred I. duPont Hospital for Children
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Wilmington, Delaware, United States
Children's National Medical Center
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Washington, District of Columbia, United States
BMT at Northside Hospital
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Atlanta, Georgia, United States
Ann and Robert H. Lurie Children's Hospital
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Chicago, Illinois, United States
University of Florida College of Medicine (Shands)
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Gainesville, Florida, United States
Johns Hopkins
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Baltimore, Maryland, United States
All Children's Hospital
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Saint Petersburg, Florida, United States
Children's Healthcare of Atlanta
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Atlanta, Georgia, United States
DFCI/Brigham & Women's
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Boston, Massachusetts, United States
H. Lee Moffitt Cancer Center
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Tampa, Florida, United States
University of Kansas Hospital
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Kansas City, Kansas, United States
Memorial Sloan-Kettering Cancer Center
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New York, New York, United States
Mayo Clinic - Rochester
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Rochester, Minnesota, United States
University of Michigan Medical Center
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Ann Arbor, Michigan, United States
Washington University/St. Louis Children's Hospital
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Saint Louis, Missouri, United States
Roswell Park
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Buffalo, New York, United States
University of North Carolina Hospital at Chapel Hill
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Chapel Hill, North Carolina, United States
Emory University
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Atlanta, Georgia, United States
Hackensack University Medical Center
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Hackensack, New Jersey, United States
Mount Sinai Medical Center
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New York, New York, United States
Washington University/Barnes Jewish Hospital
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Saint Louis, Missouri, United States
Virginia Commonwealth University
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Richmond, Virginia, United States
Cook Children's Hospital
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Fort Worth, Texas, United States