Back to resultsEnhancing Graft vs Leukemia Via Delayed Ex-Vivo Co-Stimulated DLI After Non-Myeloablative Stem Cell Transplantation
Primary Purpose
Acute Myelogenous Leukemia, Acute Lymphoblastic Leukemia, Myelodysplastic Syndrome
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Non-myeloablative allogeneic stem cell transplant with prophylactic activated DLI
"Prophylactic" delayed ADLI
"Prophylactic" delayed activated donor lymphocyte infusion
Sponsored by
About this trial
This is an interventional treatment trial for Acute Myelogenous Leukemia focused on measuring AML, ALL, MDS, Allogeneic transplant, Acute Myelogenous Leukemia, Acute Lymphoblastic Leukemia, Myelodysplastic Syndrome, Adoptive cell therapy, Non-myeloablative
Eligibility Criteria
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.
Sites / Locations
- Abramson Cancer Center at University of Pennsylvania
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
"Prophylactic" delayed activated donor lymphocyte infusion (ADLI) after non-myeloablative conditioning and allogeneic peripheral blood cell stem cell transplantation
Outcomes
Primary Outcome Measures
Evaluate the safety and feasibility of administering prophylactic donor lymphocyte infusion (DLI) after non-myeloablative transplant (NMT).
Secondary Outcome Measures
Full Information
NCT ID
NCT00374933
First Posted
September 11, 2006
Last Updated
July 10, 2019
Sponsor
Abramson Cancer Center at Penn Medicine
1. Study Identification
Unique Protocol Identification Number
NCT00374933
Brief Title
Enhancing Graft vs Leukemia Via Delayed Ex-Vivo Co-Stimulated DLI After Non-Myeloablative Stem Cell Transplantation
Official Title
Non-Myeloablative Conditioning With Allogeneic Peripheral Blood Progenitor Cell Transplantation Followed by Prophylactic Activated Donor Lymphocyte Infusion (DLI) for the Treatment of High Risk Acute Leukemia/MDS
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
April 2007 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abramson Cancer Center at Penn Medicine
4. Oversight
5. Study Description
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myelogenous Leukemia, Acute Lymphoblastic Leukemia, Myelodysplastic Syndrome
Keywords
AML, ALL, MDS, Allogeneic transplant, Acute Myelogenous Leukemia, Acute Lymphoblastic Leukemia, Myelodysplastic Syndrome, Adoptive cell therapy, Non-myeloablative
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
"Prophylactic" delayed activated donor lymphocyte infusion (ADLI) after non-myeloablative conditioning and allogeneic peripheral blood cell stem cell transplantation
Intervention Type
Drug
Intervention Name(s)
Non-myeloablative allogeneic stem cell transplant with prophylactic activated DLI
Intervention Description
"Prophylactic" delayed activated donor lymphocyte infusion (ADLI) after non-myeloablative conditioning and allogeneic peripheral blood cell stem cell transplantation
Intervention Type
Drug
Intervention Name(s)
"Prophylactic" delayed ADLI
Intervention Description
"Prophylactic" ADLI after non-myeloablative conditioning and allogeneic peripheral blood cell stem cell transplantation
Intervention Type
Drug
Intervention Name(s)
"Prophylactic" delayed activated donor lymphocyte infusion
Intervention Description
"Prophylactic" delayed activated donor lymphocyte infusion (ADLI) after non-myeloablative conditioning and allogeneic peripheral blood cell stem cell transplantation
Primary Outcome Measure Information:
Title
Evaluate the safety and feasibility of administering prophylactic donor lymphocyte infusion (DLI) after non-myeloablative transplant (NMT).
Time Frame
Six months after last patient entered on study.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven Goldstein, M.D.
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
Abramson Cancer Center at University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Enhancing Graft vs Leukemia Via Delayed Ex-Vivo Co-Stimulated DLI After Non-Myeloablative Stem Cell Transplantation
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