Ignite Creation Date:
2024-05-06 @ 2:20 PM
Last Modification Date:
2024-10-26 @ 1:29 PM
Study NCT ID:
NCT04282174
Status:
WITHDRAWN
Last Update Posted:
2022-09-27
First Post:
2020-02-17
Brief Title:
CD34 Enriched Transplants From HLA-Compatible Patients With Hematologic Malignancies
Sponsor:
Baptist Health South Florida
Organization:
Baptist Health South Florida
Study Overview
Official Title:
A Phase II Trial of CD34 Enriched Transplants From HLA-Compatible Related or Unrelated Donors for Treatment of Patients With Hematologic Malignancies
Status:
WITHDRAWN
Status Verified Date:
2022-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study was split into two new studies before the first participant was enrolled
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
2019-KOE-001
Brief Summary:
This is a Phase II trial testing disease-specific myeloablative conditioning regimens for preparatory cytoreduction of patients receiving allogeneic HLA-compatible related or unrelated transplants of GCSF-mobilized peripheral blood stem cells PBSC depleted of T-cells by positive selection of CD34 progenitor cells using the CliniMACS system The CliniMACS Fractionation system is a method that positively selects CD34 progenitor cells from PBSC by immunoadsorption of cells binding on anti CD34 monoclonal antibody to paramagnetic beads which can then be isolated by passage through a magnetized column and released by agitation of beads Two conditioning regimens have been used successfully with an alternative similar system isolex which is no longer being manufactured
Detailed Description:
For this trial patients will be put into one of two myeloablative conditioning regimens based on their disease stage of disease and dose of radiation accumulated in the course of treatment Approximately twenty-four to forty-eight hours after completion of each conditioning regimen patients will receive a transplant of a CD34 progenitor cell-enriched T-cell depleted fraction of GCSF-mobilized PBSC after fractionation on the CliniMACS device from hisher HLA compatible donor Due to stringent T-cell depletion no significant Graft-versus-host disease is anticipated Should Graft-versus-host disease occur standard treatment would be initiated per the Transplant Service guidelines
The purpose of this trial is to evaluate the potential of T-cell depleted Haploidentical Stem Cell Transplant fractionated by the CliniMACS system when administered for disease targeted cytoreductive regimens to secure consistent engraftment and hematopoietic reconstitution in HLA-compatible related or unrelated hosts and to prevent or abrogate acute and chronic forms of Graft-versus-host disease This study seeks to validate that these pre-transplant conditioning regimens when administered with a CD34 progenitor cell enriched T-cell depleted graft fractionated in the CliniMACS system will be associated with a low incidence of non-leukemic mortality
The sample size is as follows
Regimen A Hyperfractionated Total Body IrradiationThiotepaCyclophosphamide 100 patients Regimen B BusulfanMelphalanFludarabine 100 patients It is anticipated that the accrual will last five years Patients will be followed for two years following transplantation
The purpose of this trial is to evaluate the potential of T-cell depleted Haploidentical Stem Cell Transplant fractionated by the CliniMACS system when administered for disease targeted cytoreductive regimens to secure consistent engraftment and hematopoietic reconstitution in HLA-compatible related or unrelated hosts and to prevent or abrogate acute and chronic forms of Graft-versus-host disease This study seeks to validate that these pre-transplant conditioning regimens when administered with a CD34 progenitor cell enriched T-cell depleted graft fractionated in the CliniMACS system will be associated with a low incidence of non-leukemic mortality
The sample size is as follows
Regimen A Hyperfractionated Total Body IrradiationThiotepaCyclophosphamide 100 patients Regimen B BusulfanMelphalanFludarabine 100 patients It is anticipated that the accrual will last five years Patients will be followed for two years following transplantation
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None