BMT CTN 1202

Principal Investigator: Andrew Harris
Keywords: Mortality , Allogenic , HCT Department: Pediatric Hematology/Oncology
IRB Number: 00067597 Co Investigator:  
Specialty: Pediatrics, General
Sub Specialties:
Recruitment Status: Recruiting

Contact Information

Sharada Dixit
Sharada.Dixit@hsc.utah.edu
801-587-7514

Brief Summary

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.

There are no planned GWAS studies associated with the 1202 protocol, which is strictly a sample collection protocol for future research.

What we are attempting to do with our consent is to enroll only those recipients that will agree to allowing their samples and clinical data to be used for any type of BMT-related research studies.  This would include any possible future GWAS study that their sample(s) were selected for or for any other future testing (genetic or otherwise) that NIH might in the future require the sharing of these study results in dbGAP (a restricted use public database).  Having a consent such as this, with no restrictions, allows these samples to be used in a future GWAS study.  The future investigators would need to follow this policy, submit the required information and obtain IRB approvals.  Part of the future investigator’s due diligence in this process is to make certain that the consents under which the patient samples were collected allows for this type of genetic testing and data sharing.  What we are trying to accomplish for the 1202 collection would make all of these samples available for such a study.

We should point out again that the sample types that we are collecting under the 1202 consent will probably never be released for such a study.  We are storing plasma, serum and PAXgene lysates. While DNA can be isolated from the lysates, these samples will almost certainly be released for only the intended RNA gene expression studies.  We really are not storing samples under this consent that would be released for a GWAS studies.  The baseline whole blood that we are storing is collected and stored under the NMDP protocol.  These would be the samples that would be normally considered for a future GWAS study.

Inclusion Criteria

All U. S. allogeneic transplant donors and recipients weighing 10 or more kg may participate.

 

Inclusion Criteria Hematopoietic Stem Cell Recipients

 

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 10 kilograms given the volume (100ml) 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).

 

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”.

 

NMDP/CIBMTR research sample repository and CIBMTR research database protocols and consent forms referenced above are found at:

http://www.cibmtr.org/DataManagement/ProtocolConsent/Pages/index.aspx

 

 

 

 

Inclusion Criteria Hematopoietic Cell Donors

 

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.

Exclusion Criteria

none