Not provided
Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| U10HL069294-11 | U.S. NIH Grant/Contract | View source | |
| 5U24CA076518 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
| National Cancer Institute (NCI) | NIH |
| Blood and Marrow Transplant Clinical Trials Network | NETWORK |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Not provided
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:
Not provided
Not provided
Not provided
Not provided
All U.S. Allogeneic Transplant Donors and Recipients weighing 20 or more kg may participate in the collection of samples.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Mary Horowitz, MD, MS | Center for International Blood and Marrow Transplant Research (CIBMTR), Medical College of Wisconsin | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Phoenix Children's Hospital | Phoenix | Arizona | 85016 | United States | ||
| City of Hope National Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40991367 | Derived | Bhasin-Chhabra B, Wang T, Levine JE, Shenoy S, Perales MA, Bashey A, Raff H, Saber W. Soluble urokinase plasminogen activator receptor and acute kidney injury in hematopoietic cell transplantation. Blood Adv. 2025 Dec 23;9(24):6394-6401. doi: 10.1182/bloodadvances.2025016655. |
Not provided
Not provided
Findings will be published in a manuscript.
Not provided
Within 6 months of official study closure at participating sites.
Available to the public.
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Allogeneic Hematopoietic Stem Cell Transplant | Participants received allogeneic hematopoietic stem cell transplantation |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Mar 17, 2015 |
Not provided
| National Marrow Donor Program |
| OTHER |
Not provided
Not provided
Not provided
10mL serum for Proteomic studies for patients at the following time points: pre-transplant, days 7, 14, 21, 28, 42, 56, and 90.
Gene Expression studies will include the following:
| Duarte |
| California |
| 91010 |
| United States |
| Children's Hospital at Oakland | Oakland | California | 94609 | United States |
| University of CA, SF | San Francisco | California | 94143 | United States |
| Stanford Hospitals and Clinics | Stanford | California | 94305 | United States |
| Nemours/Alfred I. duPont Hospital for Children | Wilmington | Delaware | 19803 | United States |
| Children's National Medical Center | Washington D.C. | District of Columbia | 20010 | United States |
| University of Florida College of Medicine (Shands) | Gainesville | Florida | 32610 | United States |
| All Children's Hospital | St. Petersburg | Florida | 33701 | United States |
| H. Lee Moffitt Cancer Center | Tampa | Florida | 33624 | United States |
| Children's Healthcare of Atlanta | Atlanta | Georgia | 30322 | United States |
| Emory University | Atlanta | Georgia | 30322 | United States |
| BMT at Northside Hospital | Atlanta | Georgia | 30342 | United States |
| Ann and Robert H. Lurie Children's Hospital | Chicago | Illinois | 60611 | United States |
| University of Kansas Hospital | Kansas City | Kansas | 66160 | United States |
| Johns Hopkins | Baltimore | Maryland | 21231 | United States |
| DFCI/Brigham & Women's | Boston | Massachusetts | 02115 | United States |
| University of Michigan Medical Center | Ann Arbor | Michigan | 48105-2967 | United States |
| University of Minnesota | Minneapolis | Minnesota | 55455 | United States |
| Mayo Clinic - Rochester | Rochester | Minnesota | 55905 | United States |
| Washington University/Barnes Jewish Hospital | St Louis | Missouri | 63110 | United States |
| Washington University/St. Louis Children's Hospital | St Louis | Missouri | 63110 | United States |
| University of Nebraska Medical Center | Omaha | Nebraska | 68198 | United States |
| Hackensack University Medical Center | Hackensack | New Jersey | 07601 | United States |
| Roswell Park | Buffalo | New York | 14263 | United States |
| Mount Sinai Medical Center | New York | New York | 10029 | United States |
| Memorial Sloan-Kettering Cancer Center | New York | New York | 10065 | United States |
| University of North Carolina Hospital at Chapel Hill | Chapel Hill | North Carolina | 27599 | United States |
| Duke University | Durham | North Carolina | 27705 | United States |
| University Hospitals of Cleveland/Case Western | Cleveland | Ohio | 44106 | United States |
| Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | United States |
| Ohio State/Arthur G. James Cancer Hospital | Columbus | Ohio | 43210 | United States |
| Oregon Health & Science University | Portland | Oregon | 97239 | United States |
| University of Pennsylvania Cancer Center | Philadelphia | Pennsylvania | 19104 | United States |
| Children's Medical Center of Dallas | Dallas | Texas | 75235 | United States |
| Cook Children's Hospital | Fort Worth | Texas | 76104 | United States |
| Baylor College of Medicine/The Methodist Hospital | Houston | Texas | 77030 | United States |
| University of Texas/MD Anderson CRC | Houston | Texas | 77030 | United States |
| Texas Transplant Institute | San Antonio | Texas | 78229 | United States |
| Utah BMT/Primary Children's Medical Center | Salt Lake City | Utah | 84132 | United States |
| Virginia Commonwealth University | Richmond | Virginia | 23298 | United States |
| Fred Hutchinson Cancer Research Center | Seattle | Washington | 98109 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Allogeneic Hematopoietic Stem Cell Transplant | Participants received allogeneic hematopoietic stem cell transplantation |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Count of Participants | Participants | Two years from hematopoietic stem cell transplant |
|
|
|
Two years post-transplant
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Hematopoietic Stem Cell Transplant | 0 | 1,709 | 0 | 1,709 |
Not provided
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Adam Mendizabal, PhD | The Emmes Corporation | 301-251-1161 | amendizabal@emmes.com |
| Dec 1, 2022 |
| Prot_SAP_ICF_000.pdf |
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|