Ignite Creation Date:
2025-12-26 @ 2:43 PM
Ignite Modification Date:
2026-03-13 @ 4:31 PM
Study NCT ID:
NCT03016806
Status:
RECRUITING
Last Update Posted:
2025-10-10
First Post:
2016-12-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Umbilical Cord Blood Transplantation From Unrelated Donors
Sponsor:
University of Rochester
Organization:
Study Overview
Official Title:
Umbilical Cord Blood Transplantation From Unrelated Donors
Status:
RECRUITING
Status Verified Date:
2025-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is being done to determine how long it takes for the engraftment (recovery of blood cell counts) of umbilical cord stem cells and also how often engraftment of umbilical cord stem cells transplanted from an unrelated donor fails. Another purpose will be to document the rate of disease-free survival and the rate of relapse (a return of your disease or syndrome) as well as the incidence and severity of graft versus host disease (GvHD) following cord blood stem cell transplantation. GvHD is a complication of stem cell transplants in which white blood cells from the transplanted tissue (graft) attack the transplant recipient's body (host).
Detailed Description:
PRIMARY OBJECTIVES:
I. Determine the kinetics of engraftment of umbilical cord blood (UCB) following transplantation into unrelated individuals.
II. Determine the incidence of non-engraftment and secondary graft failure when unrelated donor UCB cells are administered to patients receiving myeloablative, reduced intensity cytoreductive, or non-ablative conditioning regimens together with immunosuppressive therapy.
III. Determine the incidence and severity of graft-vs-host disease (GVHD) for patients receiving unrelated donor UCB grafts.
IV. Document the overall survival, disease-free-survival, and rates of relapse for UCB transplant recipients.
OUTLINE: This is an observational study.
Patients undergo a conditioning regimen per standard of care at the discretion of the treating provider, followed by a planned UCB transplantation on study. Patients also have their medical records reviewed for engraftment data on study.
I. Determine the kinetics of engraftment of umbilical cord blood (UCB) following transplantation into unrelated individuals.
II. Determine the incidence of non-engraftment and secondary graft failure when unrelated donor UCB cells are administered to patients receiving myeloablative, reduced intensity cytoreductive, or non-ablative conditioning regimens together with immunosuppressive therapy.
III. Determine the incidence and severity of graft-vs-host disease (GVHD) for patients receiving unrelated donor UCB grafts.
IV. Document the overall survival, disease-free-survival, and rates of relapse for UCB transplant recipients.
OUTLINE: This is an observational study.
Patients undergo a conditioning regimen per standard of care at the discretion of the treating provider, followed by a planned UCB transplantation on study. Patients also have their medical records reviewed for engraftment data on study.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: