A Study of (Interleukin-12) IL-12 in Patients With Acute Myelogenous Leukemia (AML)
NCT ID: NCT02483312
Last Updated: 2025-12-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE1
9 participants
INTERVENTIONAL
2015-09-30
2026-08-31
Brief Summary
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This study will see whether modifying a patient's AML cells to produce IL-12 and giving it back to the patient is safe and useful in patients with AML that cannot have bone marrow transplants.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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IL-12
A single dose of IL-12, given intravenously.
IL-12
Interventions
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IL-12
Eligibility Criteria
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Inclusion Criteria
* Agrees to participate in the study and signs the informed consent
* Viable cells are available for successful modification
* First or higher complete remission and have high risk features of relapse.
* Patients who have received prior treatment and are not in remission must have stable white blood cell count and are not receiving any chemotherapy or desiring further intensive treatment.
* Less than 10% blast cells in the bone marrow following induction or re-induction therapy and not desiring further intensive treatment.
* Acceptable creatinine, Aspartate transaminase (AST), Alkaline phosphatase (ALP), bilirubin lab results.
* Agree to use contraception
* Not pregnant
* Able to comply with study procedures
Exclusion Criteria
* Known persistent infection
* Known central nervous system (CNS) disease
* Greater than 10% blasts in the bone marrow or circulating blast cells
* Life expectancy \< 2 months
* Receiving any chemotherapy, corticosteroids, Cox2 inhibitors or any non-drug therapies with the intent of altering the immune response or kill leukemic cells within one week prior to infusion of IL-12, except azacytidine.
* Patients who are HIV positive.
18 Years
ALL
No
Sponsors
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Ozmosis Research Inc.
INDUSTRY
University Health Network, Toronto
OTHER
Responsible Party
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Principal Investigators
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Hassan Sibai, M.D.
Role: PRINCIPAL_INVESTIGATOR
Princess Margaret Cancer Centre
Locations
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Princess Margaret Centre Centre
Toronto, Ontario, Canada
Countries
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Other Identifiers
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DDP-IL-12
Identifier Type: -
Identifier Source: org_study_id
OZM-068
Identifier Type: OTHER
Identifier Source: secondary_id
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