Ignite Creation Date:
2024-05-05 @ 10:05 PM
Last Modification Date:
2024-10-26 @ 10:13 AM
Study NCT ID:
NCT01027702
Status:
TERMINATED
Last Update Posted:
2022-04-22
First Post:
2009-12-07
Brief Title:
Donor Lymphocyte Infusion After Alternative Donor Transplantation
Sponsor:
Wake Forest University Health Sciences
Organization:
Wake Forest University Health Sciences
Study Overview
Official Title:
Phase III Study of Donor Lymphocyte Infusion With Methotrexate GVHD Prophylaxis to Hasten Immune Reconstitution After CD34 Cell-Selected Transplant
Status:
TERMINATED
Status Verified Date:
2017-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Sponsor PI leaving institution no plans to continue this research at this time
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine the ability of a donor lymphocyte infusion DLI given with methotrexate to hasten immune recovery without causing severe graft-versus-host disease GVHD in recipients who have had a T-cell depleted transplant
Detailed Description:
Studies have shown that giving donor T cells after a mismatched T cell-depleted stem cell transplant can speed up recovery of T cells in the patient This approach can cause severe graft versus host disease GVHD The purpose of this study is to determine whether giving a donor lymphocyte infusion DLI with methotrexate can accelerate immune recovery in recipients of T cell-depleted stem cell transplants Thirty days after a T-cell depleted transplant patients will be given a DLI They will be monitored for immune recovery as measured by CD4 count and for GVHD toxicity
Patients will be separated into six cohorts based on dose of DLI received 3 x 104 4 x 104 5 x 104 6 X 104 8 x 104 and 10 X104 cells kg of body weight A minimum of 3 patients will be tested at each dose starting with the lowest dose Dose escalation will continue until the dose associated with CD4 count 100 at Day 120 after transplant without significant GVHD is determined All patients will receive thirteen doses of methotrexate after the DLI to prevent GVHD Patients will be followed for 2 years for outcomes
Patients will be separated into six cohorts based on dose of DLI received 3 x 104 4 x 104 5 x 104 6 X 104 8 x 104 and 10 X104 cells kg of body weight A minimum of 3 patients will be tested at each dose starting with the lowest dose Dose escalation will continue until the dose associated with CD4 count 100 at Day 120 after transplant without significant GVHD is determined All patients will receive thirteen doses of methotrexate after the DLI to prevent GVHD Patients will be followed for 2 years for outcomes
Study Oversight
Has Oversight DMC:
None
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?:
None