Donor Lymphocyte Infusion After Alternative Donor Transplantation
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Immunocompromised After T-cell Depleted Transplant. |
Biological: Infusion of donor lymphocytes |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase I/II Study of Donor Lymphocyte Infusion With Methotrexate GVHD Prophylaxis to Hasten Immune Reconstitution After CD34+ Cell-Selected Transplant |
- Immune recovery following transplantation [ Time Frame: 120 days after transplant ] [ Designated as safety issue: No ]
- Incidence and severity of GVHD [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
- Determine incidence of infection and EBV-related post-transplant lymphoproliferative disease (PTLD) [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 60 |
| Study Start Date: | August 2009 |
| Estimated Study Completion Date: | June 2016 |
| Estimated Primary Completion Date: | June 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
Detailed 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 +100 after transplant without significant GVHD is determined. All patients will receive nine doses of methotrexate after the DLI to prevent GVHD. Patients will be followed for 2 years for outcomes.
Eligibility| Ages Eligible for Study: | up to 30 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Contact: Andrew Gilman, MD | 704-381-9902 | andrew.gilman@carolinashealthcare.org |
| Contact: Krishna Shah, MS | 980-442-2309 | krishna.shah@carolinashealthcare.org |
| United States, North Carolina | |
| Levine Children's Hospital, Carolinas Medical Center | Recruiting |
| Charlotte, North Carolina, United States, 28203 | |
| Contact: Andrew Gilman, MD 704-381-9902 andrew.gilman@carolinashealthcare.org | |
| Contact: Krishna Shah, MS 980-442-2309 krishna.shah@carolinashealthcare.org | |
| Principal Investigator: Andrew Gilman, MD | |
| Sub-Investigator: Michael Eckrich, MD | |
| Sub-Investigator: Javier Oesterheld, MD | |
| Sub-Investigator: Chad Jacobson, MD | |
| Sub-Investigator: Joel Kaplan, MD | |
| Principal Investigator: | Andrew Gilman, MD | Department of Pediatrics, Levine Children's Hospital, Carolinas Healthcare System |
More Information
No publications provided
| Responsible Party: | Andrew Gilman, Director, Pediatric Blood and Marrow Transplantation, Carolinas Healthcare System |
| ClinicalTrials.gov Identifier: | NCT01027702 History of Changes |
| Other Study ID Numbers: | LCH BMT 09-02 |
| Study First Received: | December 7, 2009 |
| Last Updated: | November 15, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Carolinas Healthcare System:
|
Donor Lymphocyte Infusion Immune Recovery T cell depleted transplant Mismatched related donor transplants Unrelated donor transplants |
ClinicalTrials.gov processed this record on May 16, 2013