Prospective Multi-Center Cohort for the Evaluation of Biomarkers Predicting Risk of Complications and Mortality Following Allogeneic HCT (BMT Clinical Trials Network (CTN)#1202)
N/A
N/A
Both
Recipients of Allogeneic Hematopoietic Stem Cell Transplantation
Trial Information
Prospective Multi-Center Cohort for the Evaluation of Biomarkers Predicting Risk of Complications and Mortality Following Allogeneic HCT (BMT Clinical Trials Network (CTN)#1202)
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 biospecimen
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.
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
Type of Study:
Observational [Patient Registry]
Study Design:
Observational Model: Cohort, Time Perspective: Prospective
Outcome Measure:
Establish a cohort of biologic samples
Outcome Description:
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 biospecimen resource for conducting future correlative studies.
Outcome Time Frame:
Two years from hematopoietic stem cell transplant
Safety Issue:
No
Principal Investigator
Mary Horowitz, MD, MS
Investigator Role:
Study Director
Investigator Affiliation:
Center for International Blood and Marrow Transplant Research (CIBMTR), Medical College of Wisconsin
Authority:
United States: Federal Government
Study ID:
BMTCTN1202
NCT ID:
NCT01879072
Start Date:
June 2013
Completion Date:
July 2019
Related Keywords:
- Recipients of Allogeneic Hematopoietic Stem Cell Transplantation
- Biomarkers
- Hematopoietic stem cell transplant
Name | Location |
|---|---|
| University of Michigan Medical Center | Ann Arbor, Michigan 48104-0914 |
| University of Texas/MD Anderson CRC | Houston, Texas 77030 |
| Nemours Childrens Clinic | Jacksonville, Florida 32207 |
| Stanford Hospitals and Clinics | Stanford, California 94305 |
