Collection of Samples and Data for the National Marrow Donor Program Repository
| Status: | Recruiting |
|---|---|
| Conditions: | Blood Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | Any - 100 |
| Updated: | 4/6/2019 |
| Start Date: | June 29, 2007 |
| Contact: | Dianne M Hilligoss, C.R.N.A. |
| Email: | dhilligoss@mail.nih.gov |
| Phone: | (301) 594-5945 |
The Collection of Research Samples and/or Data for Repository From Related or Unrelated Hematopoietic Stem Cell Transplantation Recipients for the National Marrow Donor Program
This protocol will collect blood samples and medical information from patients who have had a
bone marrow transplant using cells from an unrelated donor identified through the National
Marrow Donor Program (NMDP). The NMDP has two programs in which patients can participate: the
Research Database Program and the Research Sample Repository.
Patients who have received a bone marrow transplant at the NIH or other institution from an
unrelated donor affiliated with the NMDP may be eligible for this study.
Participants in the NMDP Research Database program will have medical information about their
disease and their transplant sent to the NMDP before and after the transplant and once a year
for the rest of their life. The information will be used to help determine how well
transplant recipients recover from their transplant, how recovery after a transplant can be
improved, how access to transplant for different groups of patients can be improved and how
well donors recover from collection procedures.
Participants in the NMDP Research Sample Repository program will have a small blood sample
drawn from a vein in the arm just before they start taking medicines for the conditioning
regimen to prepare them for the transplant. The blood samples will be used to look at ways to
improve how patients are matched with their donors, to determine and evaluate the factors
that affect transplant outcome, and to help develop methods to improve tissue matching
between donors and recipients....
bone marrow transplant using cells from an unrelated donor identified through the National
Marrow Donor Program (NMDP). The NMDP has two programs in which patients can participate: the
Research Database Program and the Research Sample Repository.
Patients who have received a bone marrow transplant at the NIH or other institution from an
unrelated donor affiliated with the NMDP may be eligible for this study.
Participants in the NMDP Research Database program will have medical information about their
disease and their transplant sent to the NMDP before and after the transplant and once a year
for the rest of their life. The information will be used to help determine how well
transplant recipients recover from their transplant, how recovery after a transplant can be
improved, how access to transplant for different groups of patients can be improved and how
well donors recover from collection procedures.
Participants in the NMDP Research Sample Repository program will have a small blood sample
drawn from a vein in the arm just before they start taking medicines for the conditioning
regimen to prepare them for the transplant. The blood samples will be used to look at ways to
improve how patients are matched with their donors, to determine and evaluate the factors
that affect transplant outcome, and to help develop methods to improve tissue matching
between donors and recipients....
The National Institutes of Health (NIH) has entered into a Transplant Center Participation
Agreement with the National Marrow Donor Program (NMDP). This agreement allows any NIH
investigator with an NIH Institutional Review Board (IRB) approved protocol to secure
hematopoietic stem cells (HSC) or cord blood units from the NMDP/CIBMTR registry for the
purpose of transplanting patients who have no suitable matched related donors. As part of
this agreement, the NMDP/CIBMTR Research Program requires that blood samples as well as
baseline and outcome data (mainly demographic, quality of life, and clinical data) be
collected and maintained in accordance with the NMDP/CIBMTR IRB approved protocols. The goal
of the NMDP/CIBMTR Research Program is to improve the safety and effectiveness of unrelated
donor HSC transplantation for both the donors and recipients, and to have a comprehensive
source of data that can be used to study unrelated donor HSC transplantation. The NMDP/CIBMTR
is the sole custodian of the data in the Research Database.
The primary purpose of this protocol is to incorporate all the NMDP/CIBMTR requirements for
securing data and blood samples on recipients whose transplant was facilitated by NMDP/CIBMTR
here at NIH as well as TED (Transplant Essential Data) level data submission for NIAID
Allogeneic recipient patients and their donors. This protocol will include patients at the
NIH that have enrolled in an NIH IRB approved protocol to receive matched unrelated donor
(MUD) HSC transplants or cord blood transplants facilitated by the NMDP/CIBMTR. It may also
include patients that have undergone a MUD transplant at another approved transplant center
but need to receive additional blood products from the donor while at NIH after completing a
transplant center transfer.
Agreement with the National Marrow Donor Program (NMDP). This agreement allows any NIH
investigator with an NIH Institutional Review Board (IRB) approved protocol to secure
hematopoietic stem cells (HSC) or cord blood units from the NMDP/CIBMTR registry for the
purpose of transplanting patients who have no suitable matched related donors. As part of
this agreement, the NMDP/CIBMTR Research Program requires that blood samples as well as
baseline and outcome data (mainly demographic, quality of life, and clinical data) be
collected and maintained in accordance with the NMDP/CIBMTR IRB approved protocols. The goal
of the NMDP/CIBMTR Research Program is to improve the safety and effectiveness of unrelated
donor HSC transplantation for both the donors and recipients, and to have a comprehensive
source of data that can be used to study unrelated donor HSC transplantation. The NMDP/CIBMTR
is the sole custodian of the data in the Research Database.
The primary purpose of this protocol is to incorporate all the NMDP/CIBMTR requirements for
securing data and blood samples on recipients whose transplant was facilitated by NMDP/CIBMTR
here at NIH as well as TED (Transplant Essential Data) level data submission for NIAID
Allogeneic recipient patients and their donors. This protocol will include patients at the
NIH that have enrolled in an NIH IRB approved protocol to receive matched unrelated donor
(MUD) HSC transplants or cord blood transplants facilitated by the NMDP/CIBMTR. It may also
include patients that have undergone a MUD transplant at another approved transplant center
but need to receive additional blood products from the donor while at NIH after completing a
transplant center transfer.
- INCLUSION CRITERIA:
Patients (Recipient):
Must be enrolled on an NIH IRB approved protocol which involves an HSC transplant or
cellular therapy utilizing HSC from an unrelated donor affiliated with the NMDP.
May include recipients who have received an NMDP facilitated HSC transplant at other
institutions, provided the patient consents to and completes a Transplant Center transfer.
Ability to comprehend and willing to sign the informed consent or have a parent/guardian
consent if the donor is a minor; assent obtained from minors as appropriate.
NIAID Allogeneic (related matched) recipients for TED level data submission only.
Donors of related transplant.
EXCLUSION CRITERIA:
The patient has received an HSC transplant or cellular therapy utilizing HSC from an
unrelated donor facilitated by a registry other than NMDP.
Non-NIAID Allogeneic (sibling matched) Recipients.
We found this trial at
1
site
9000 Rockville Pike
Bethesda, Maryland 20892
Bethesda, Maryland 20892
Phone: 800-411-1222
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