Enhancing Graft vs Leukemia Via Delayed Ex-Vivo Co-Stimulated DLI After Non-Myeloablative Stem Cell Transplantation
Completed · Phase 1
Conditions studied: Acute Myelogenous Leukemia, Acute Lymphoblastic Leukemia, Myelodysplastic Syndrome
In brief
This is a new platform in non-myeloablative allogeneic stem cell transplantation to improve survival by harnessing the immunologic potential of donor T-cells to induce and maintain long-term remissions in patients with hematologic malignancies without undue toxicity. This study involves is the first study in humans directed at optimizing the graft vs leukemia effect by infusing activated T-cells from healthy donors prophylactically, months after recovery from the initial transplant. Investigators are studying whether the activation of donor cells prior to infusion will enhance the patient's ability to "seek and destroy" residual malignant cells while also helping the immune system to fight infection without increasing the immune reaction against the host.
Key facts
- Study ID
- NCT00374933
- Run by
- Abramson Cancer Center at Penn Medicine
- People needed
- 18
- Starts
- 2007-04-01
- Expected to finish
- 2009-12-01
- Last updated by the study team
- 2019-07-12
Who can join
Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.
You may not qualify if…
- Subjects:
- Patients who have had chemotherapy or radiotherapy within 4 weeks prior to entering the study. Patients must have recovered from adverse events due to agents administered more than 4 weeks earlier.
- Patients with uncontrolled or untreated central nervous system involvement
- Patients with uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- HIV positive patients are excluded
- Pregnant women
- Patients who are breastfeeding
- Donors:
- Sibling donors will be evaluated according to the standard practice of the University of Pennsylvania Bone Marrow and Stem Cell Transplant Program
- Unrelated donor evaluations and consent will be performed by an NMDP donor center according to standard guidelines and procedures.
Where it is running
- Abramson Cancer Center at University of Pennsylvania — Philadelphia, Pennsylvania, United States
Full record on ClinicalTrials.gov
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