N/A N=1,860

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

Allogeneic Hematopoietic Stem Cell Transplantation

Bottom Line

View on ClinicalTrials.gov: NCT01879072 ↗

Enrolled (actual)

1,860

Serious AEs

0.0%

Results posted

May 2018

Primary outcome: Primary: Number of Participants Providing Biologic Samples — 1709 Participants

Study Design & Population

Study type: Observational
Phase: N/A
Interventions: —
Age: Pediatric, Adult, Older Adult
Sex: All
Sponsor: Medical College of Wisconsin
Primary completion: Sep 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants Providing Biologic Samples	1709	—

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.

Eligibility Criteria

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

N/A

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01879072). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.