Prospective Cohort for the Evaluation of Biomarkers Following HCT (BMT CTN 1202)
Allogeneic Hematopoietic Stem Cell Transplantation
|Study Type:||Observational [Patient Registry]|
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Target Follow-Up Duration:||2 Years|
|Official Title:||Prospective Multi-Center Cohort for the Evaluation of Biomarkers Predicting Risk of Complications and Mortality Following Allogeneic HCT (BMT CTN #1202)|
- Establish a cohort of at least 1500 biologic samples [ Time Frame: Two years from hematopoietic stem cell transplant ] [ Designated as safety issue: No ]To describe patterns of disease among patients undergoing allogeneic hematopoietic stem cell. 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.
- Acute Graft-versus-host disease (aGVHD) [ Time Frame: Day 100 ] [ Designated as safety issue: No ]To describe patterns of aGVHD using The date of onset, severity, target organ involvement, treatment, and evolution over time, including response to treatment of acute GVHD is the main outcome of interest for future testing of the collected samples.
- Chronic Graft-versus-host disease (cGVHD) [ Time Frame: Two years post-transplant ] [ Designated as safety issue: No ]To describe patterns of cGVHD including the date of onset, severity, target organ involvement and evolution of chronic graft-versus-host disease.
- Infections [ Time Frame: Day 100 ] [ Designated as safety issue: No ]To describe patterns of infections through day 100.
- Relapse/Progression [ Time Frame: Two years ] [ Designated as safety issue: No ]To describe patterns of relapse/progression post-transplant.
- Acute liver injury [ Time Frame: Day 100 ] [ Designated as safety issue: No ]To describe patterns of acute liver injury.
- Lung Injury [ Time Frame: Two years ] [ Designated as safety issue: No ]To describe patterns of lung injury post-transplant.
- Transplant-related mortality (TRM) [ Time Frame: Two years ] [ Designated as safety issue: No ]To describe patterns of TRM post-transplant.
Biospecimen Retention: Samples With DNA
10mL serum for Proteomic studies for all 1500 patients at the following time points: pre-transplant, days 7, 14, 21, 28, 42, 56, and 90.
Gene Expression studies will include the following:
- PAXgene Lysates-source whole blood RNA (15 ml blood) for 240 patients collected on days 21, 56, and 90.
- CytoChex tube for Immunophenotyping (4-5 mL blood) collected on days 21, 56, and 90.
|Study Start Date:||June 2013|
|Estimated Study Completion Date:||July 2019|
|Estimated Primary Completion Date:||July 2019 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01879072
|Contact: Heather Wittsackfirstname.lastname@example.org|
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|Study Director:||Mary Horowitz, MD, MS||Center for International Blood and Marrow Transplant Research (CIBMTR), Medical College of Wisconsin|