Status:
COMPLETED
Enhancing Graft vs Leukemia Via Delayed Ex-Vivo Co-Stimulated DLI After Non-Myeloablative Stem Cell Transplantation
Lead Sponsor:
Abramson Cancer Center at Penn Medicine
Conditions:
Acute Myelogenous Leukemia
Acute Lymphoblastic Leukemia
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
Brief Summary
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 remission...
Eligibility Criteria
Inclusion
- Patient-related Parameters:
- Patients must have a healthy histocompatible donor (A, B and DR match); either sibling or unrelated volunteer identified through the NMDP
- Age between 18 and 70 years old
- Life expectancy greater than 3 months.
- ECOG performance status 0-1.
- Patients must have acceptable organ function:
- total bilirubin \<2.0
- AST and ALT \< 3 x normal, unless increases are thought to be either from non-hepatic causes (i.e hemolysis) or related to underlying disease (such as liver involvement with leukemia);
- creatinine \<2.0 or creatinine clearance \>40 ml/min (calculated or collected);
- Cardiac: An ejection fraction \>40% on MUGA or echocardiogram;
- Pulmonary: corrected DLCO \>50%
- Exclusion Criteria:
- 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.
Exclusion
Key Trial Info
Start Date :
April 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT00374933
Start Date
April 1 2007
End Date
December 1 2009
Last Update
July 12 2019
Active Locations (1)
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1
Abramson Cancer Center at University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104