Donor Lymphocyte Infusion After Alternative Donor Transplantation
|ClinicalTrials.gov Identifier: NCT01027702|
Recruitment Status : Terminated (Sponsor/ PI leaving institution, no plans to continue this research at this time)
First Posted : December 9, 2009
Results First Posted : November 8, 2017
Last Update Posted : November 8, 2017
|Condition or disease||Intervention/treatment||Phase|
|Immunodeficiency||Biological: Infusion of donor lymphocytes||Phase 1 Phase 2|
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 10^4, 4 x 10^4, 5 x 10^4, 6 X 10^4, 8 x 10^4, and 10 X10^4 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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||38 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I/II Study of Donor Lymphocyte Infusion With Methotrexate GVHD Prophylaxis to Hasten Immune Reconstitution After CD34+ Cell-Selected Transplant|
|Study Start Date :||August 2009|
|Actual Primary Completion Date :||November 2016|
|Actual Study Completion Date :||November 2016|
Experimental: Infusion of donor lymphocytes
Patients will receive an infusion of donor lymphocyte after T-cell depleted transplant.
Biological: Infusion of donor lymphocytes
A donor lymphocyte infusion will be given to provide T cells. There will be a dose escalation: 3 x 10^4, 4 x 10^4, 5 x 10^4, 6 X 10^4, 8 x 10^4, and 10 X10^4 cells/kg body weight. At least three patients will be assessed at each dose to determine safety before dose is increased.
- Number of Participants With Immune Recovery Following Transplantation [ Time Frame: 120 days after transplant ]Immune recovery was measured by CD4+ cells > 100/μL by Day 120 following transplantation
- Incidence and Severity of GVHD [ Time Frame: 180 days after transplant ]Patients were evaluated for acute GVHD due to prophylactic DLI between the day of prophylactic DLI infusion and Day +180 after transplant. GVHD was graded using standard criteria.
- Number of Participants With Infection and EBV-related Post-transplant Lymphoproliferative Disease (PTLD) [ Time Frame: 1 year ]Subjects were actively monitored for adenovirus, cytomegalovirus (CMV), human herpes virus 6 (HHV6), and Epstein-Barr virus (EBV) as part of standard post-transplant care. All infections were collected from date of DLI until 1 year after transplant.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01027702
|United States, North Carolina|
|Levine Children's Hospital, Carolinas Medical Center|
|Charlotte, North Carolina, United States, 28203|
|Principal Investigator:||Andrew Gilman, MD||Department of Pediatrics, Levine Children's Hospital, Carolinas Healthcare System|