Enhancing Graft vs Leukemia Via Delayed Ex-Vivo Co-Stimulated DLI After Non-Myeloablative Stem Cell Transplantation (NCT00374933)

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Study 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.

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Conditions studied

Acute Myelogenous Leukemia
Acute Lymphoblastic Leukemia
Myelodysplastic Syndrome

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Keywords

AML
ALL
MDS
Allogeneic transplant
Acute Myelogenous Leukemia
Acute Lymphoblastic Leukemia
Myelodysplastic Syndrome
Adoptive cell therapy
Non-myeloablative

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In context

Leukemia, Myeloid, Acute

3,035 studies on the registry are indexed under Leukemia, Myeloid, Acute; 746 are open to participants now.

This study's enrollment of 18 is below the median of 40 across 2,561 interventional studies indexed under Leukemia, Myeloid, Acute.

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Lead sponsor

Abramson Cancer Center at Penn Medicine is the lead sponsor of 457 studies on the registry; 84 are open to participants now.

Of its 33 completed or terminated interventional studies of FDA-regulated products, 14 (42%) have results posted.

Browse Abramson Cancer Center at Penn Medicine studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible: 18 Years to 70 Years
Sexes eligible: All
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.

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Study design

Phase: Phase 1
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 18 participants (actual)

Study arms

Experimental
1
"Prophylactic" delayed activated donor lymphocyte infusion (ADLI) after non-myeloablative conditioning and allogeneic peripheral blood cell stem cell transplantation
Drug: Non-myeloablative allogeneic stem cell transplant with prophylactic activated DLI · Drug: "Prophylactic" delayed ADLI · Drug: "Prophylactic" delayed activated donor lymphocyte infusion

Interventions

DrugNon-myeloablative allogeneic stem cell transplant with prophylactic activated DLI
"Prophylactic" delayed activated donor lymphocyte infusion (ADLI) after non-myeloablative conditioning and allogeneic peripheral blood cell stem cell transplantation
Drug"Prophylactic" delayed ADLI
"Prophylactic" ADLI after non-myeloablative conditioning and allogeneic peripheral blood cell stem cell transplantation
Drug"Prophylactic" delayed activated donor lymphocyte infusion
"Prophylactic" delayed activated donor lymphocyte infusion (ADLI) after non-myeloablative conditioning and allogeneic peripheral blood cell stem cell transplantation

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What researchers measure

Primary outcomes

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.

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Study locations

1 site

Abramson Cancer Center at University of Pennsylvania
Philadelphia, Pennsylvania 19104, United States

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Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jul 12, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

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Registry details

Key details

Study ID: NCT00374933
Lead sponsor: Abramson Cancer Center at Penn Medicine
Responsible party: Sponsor
First posted: Sep 12, 2006
Start date: Apr 2007
Primary completion: Dec 2009
Completion: Dec 2009
Last update: Jul 12, 2019

Study contacts

Steven Goldstein, M.D.

principal investigator · University of Pennsylvania

View the source record on ClinicalTrials.gov ↗

Enhancing Graft vs Leukemia Via Delayed Ex-Vivo Co-Stimulated DLI After Non-Myeloablative Stem Cell Transplantation