Ignite Creation Date:
2024-05-06 @ 3:03 AM
Last Modification Date:
2024-10-26 @ 11:28 AM
Study NCT ID:
NCT02199041
Status:
TERMINATED
Last Update Posted:
2018-02-07
First Post:
2014-07-09
Brief Title:
Combined T Cell Depleted Haploidentical Peripheral Blood Stem Cell and Unrelated Umbilical Cord Blood Transplantation in Patients With Hematologic Malignancies Using a Total Lymphoid Irradiation Based Preparative Regimen
Sponsor:
St Jude Childrens Research Hospital
Organization:
St Jude Childrens Research Hospital
Study Overview
Official Title:
Combined T Cell Depleted Haploidentical Peripheral Blood Stem Cell and Unrelated Umbilical Cord Blood Transplantation in Patients With Hematologic Malignancies Using a Total Lymphoid Irradiation Based Preparative Regimen
Status:
TERMINATED
Status Verified Date:
2017-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The study was halted early due to slow accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
In this study participants with high-risk hematologic malignancies undergoing hematopoietic cell transplantation HCT who do not have a suitable human leukocyte antigen HLA-matched relatedsibling donor MSD matched unrelated donor MURD or killer-immunoglobulin receptors KIR ligand mismatched haploidentical donor identified will receive a combined T cell depleted TCD haploidentical peripheral blood stem cell PBSC and unrelated umbilical cord blood transplantation UCBT using a total lymphoid irradiation TLI based preparative regimen
Primary objective
To estimate the incidence of donor derived neutrophil engraftment by day 42 post-transplant for participants with high-risk hematologic malignancies undergoing a total lymphoid irradiation TLI-based hematopoietic cell transplantation HCT using a T cell depleted TCI haploidentical donor peripheral blood stem cell PBSC donor combined with an unrelated umbilical cord blood UCB donor
Secondary objectives
Estimate the incidence of malignant relapse event-free survival EFS and overall survival OS at one-year post-transplantation
Estimate the incidence and severity of acute and chronic graft versus host disease GVHD in the first 100 days after transplantation
Estimate the incidence of secondary graft failure transplant related mortality TRM and transplant related morbidity in the first 100 days after HCT
Primary objective
To estimate the incidence of donor derived neutrophil engraftment by day 42 post-transplant for participants with high-risk hematologic malignancies undergoing a total lymphoid irradiation TLI-based hematopoietic cell transplantation HCT using a T cell depleted TCI haploidentical donor peripheral blood stem cell PBSC donor combined with an unrelated umbilical cord blood UCB donor
Secondary objectives
Estimate the incidence of malignant relapse event-free survival EFS and overall survival OS at one-year post-transplantation
Estimate the incidence and severity of acute and chronic graft versus host disease GVHD in the first 100 days after transplantation
Estimate the incidence of secondary graft failure transplant related mortality TRM and transplant related morbidity in the first 100 days after HCT
Detailed Description:
Prior to stem cell infusion participants will receive a preparative regimen of total lymphoid irradiation TLI fludarabine cyclophosphamide melphalan and thiotepa to prepare their bone marrow Thereafter they will receive a hematopoietic cell graft from a haploidentical donor and an unrelated umbilical cord blood donor Post-transplantation immunosuppressive treatment will include tacrolimus and mycophenolate mofetil
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2014-00526 | REGISTRY | NCI Clinical Trial Registration Program | None |