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Donor Lymphocyte Infusion After Alternative Donor Transplantation

NCT01027702 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2022-04-22

Study results available
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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.

Conditions

  • Immunodeficiency

Interventions

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.

Sponsors & Collaborators

  • Wake Forest University Health Sciences

    lead OTHER

Principal Investigators

  • Andrew Gilman, MD · Department of Pediatrics, Levine Children's Hospital, Carolinas Healthcare System

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
30 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-08-31
Primary Completion
2016-11-30
Completion
2016-11-30

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01027702 on ClinicalTrials.gov