Details
Description
Inclusion Criteria
Exclusion Criteria
Details
Title Prospective Multi-Center Cohort for the Evaluation of Biomarkers Predicting Risk of Complications and Mortality Following Allogeneic HCT
IRB CTN1202
CC 14-419
Hospital Main Campus
Disease Blood & Marrow Transplant (BMT)
Description
- 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 hematopoietic stem cell transplantation (HCT) correlative studies.
Inclusion Criteria
Hematopoietic Stem Cell Recipients- 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. Upon reaching accrual of 1500 patients, only non-Caucasian adults and pediatric participants will be eligible for enrollment. A subset of 240 sequential patients with acute leukemia in first or second remission will also provide research samples for gene expression studies. A minimum of 200 African American participants will be enrolled on this protocol.
- Children may participate in this study but must weigh at least 10 kilograms given the volume (100 mL) and number of blood draws during this study (see Section 4.3.3 for blood volume adjustments for patients weighing between 10 and 20 kg). Subjects must weigh at least 30 kg to provide research samples for gene expression studies (additional 40 mL). A minimum of 200 pediatric participants, defined as <18.0 years at the time of enrollment, will be enrolled on this protocol.
- 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."
- The data and samples obtained from patients on this protocol are linked to donor data and samples obtained from a separate NMDP/CIBMTR protocol, "Protocol for a Research Sample Repository for Allogeneic Hematopoietic Stem Cell Transplantation and Marrow Toxic Injuries." No donor specimens will be collected under this protocol. Samples from donors will be obtained under the protocol specified above using the standard NMDP mechanism for the collection of donor samples.
