Donor Lymphocyte Infusion After Alternative Donor Transplantation

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-08-31

Study Completion Date

2016-11-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Immunodeficiency

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Infusion of donor lymphocytes

Patients will receive an infusion of donor lymphocyte after T-cell depleted transplant.

Group Type EXPERIMENTAL

Infusion of donor lymphocytes

Intervention Type BIOLOGICAL

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.

Interventions

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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.

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Patients must have been treated on the LCH BMT 09-01 protocol
* Signed informed consent by patient or legal guardian

Exclusion Criteria

* Active GVHD at the time when DLI are due
* History of acute GVHD \> grade I prior to DLI
* Disease due to viral infection (eg. CMV) when DLI are due (asymptomatic viral replication or viral shedding is not a contraindication)
* Uncontrolled bacterial or fungal infection
* O2 saturation by pulse oximetry \< 95%
* Bilirubin \> 3mg/dL or ALT \> 5 x upper limit of normal
* Creatinine \> 3x baseline (at transplant)
* ANC (WBC x % neutrophils + bands) \< 500/ul
* Significant effusions (eg. pleural or pericardial) or ascites
* EBV-related PTLD
* Persistent or increasing mixed chimerism requiring therapeutic DLI as defined on the LCH BMT 09-01 protocol

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No