Donor Lymphocyte Infusion After Alternative Donor Transplantation

Wake Forest University (WFU) logo

Wake Forest University (WFU)

Status and phase

Terminated
Phase 2
Phase 1

Conditions

Immunodeficiency

Treatments

Biological: Infusion of donor lymphocytes

Study type

Interventional

Funder types

Other

Identifiers

NCT01027702
LCH BMT 09-02

Details and patient eligibility

About

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.

Full 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 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.

Enrollment

38 patients

Sex

All

Ages

Under 30 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

38 participants in 1 patient group

Infusion of donor lymphocytes
Experimental group
Description:
Patients will receive an infusion of donor lymphocyte after T-cell depleted transplant.
Treatment:
Biological: Infusion of donor lymphocytes

Trial documents
2

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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