Donor Lymphocyte Infusion After Alternative Donor Transplantation
| Status: | Terminated |
|---|---|
| Conditions: | Infectious Disease, HIV / AIDS |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | Any - 30 |
| Updated: | 11/10/2017 |
| Start Date: | August 2009 |
| End Date: | November 2016 |
Phase I/II Study of Donor Lymphocyte Infusion With Methotrexate GVHD Prophylaxis to Hasten Immune Reconstitution After CD34+ Cell-Selected Transplant
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.
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.
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.
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.
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
We found this trial at
1
site
Charlotte, North Carolina 28203
Principal Investigator: Andrew Gilman, MD
Phone: 704-381-9900
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