An observational study in Allogeneic Hematopoietic Stem Cell Transplantation, sponsored by Medical College of Wisconsin. Completed at 42 sites in United States. Per ClinicalTrials.gov, last updated 2022-12-09.
Sponsored by Medical College of Wisconsin · Observational
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.
Medical College of Wisconsin is the lead sponsor of 540 studies on the registry; 120 are open to participants now.
Of its 71 completed or terminated interventional studies of FDA-regulated products, 56 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
All U.S. Allogeneic Transplant Donors and Recipients weighing 20 or more kg may participate in the collection of samples.
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
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:
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.
Time frame: Two years from hematopoietic stem cell transplant
| Milestone | Allogeneic Hematopoietic Stem Cell Transplant |
|---|---|
| Started | 1860 |
| Completed | 1709 |
| Not completed | 151 |
| Withdrew: Withdrawal by subject | 121 |
| Withdrew: Not transplanted | 30 |
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.
| Participants | Allogeneic Hematopoietic Stem Cell Transplant |
|---|---|
| Number of Participants Providing Biologic Samples | 1709 |
Collected over Two years post-transplant. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Hematopoietic Stem Cell Transplant | — | 0/1,709 (0%) | 0/1,709 (0%) |
| Age, Continuous(years) | Allogeneic Hematopoietic Stem Cell Transplant |
|---|---|
| Median | 52.7 (0.5 to 77.3) |
| Sex: Female, Male(Participants) | Allogeneic Hematopoietic Stem Cell Transplant |
|---|---|
| Female | 701 |
| Male | 1008 |
| Ethnicity (NIH/OMB)(Participants) | Allogeneic Hematopoietic Stem Cell Transplant |
|---|---|
| Hispanic or Latino | 128 |
| Not Hispanic or Latino | 1552 |
| Unknown or Not Reported | 29 |
| Race (NIH/OMB)(Participants) | Allogeneic Hematopoietic Stem Cell Transplant |
|---|---|
| American Indian or Alaska Native | 9 |
| Asian | 59 |
| Native Hawaiian or Other Pacific Islander | 5 |
| Black or African American | 203 |
| White | 1370 |
| More than one race | 13 |
| Unknown or Not Reported | 50 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — Findings will be published in a manuscript.
This study is completed, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.
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Medical College of Wisconsin