A Study of (Interleukin-12) IL-12 in Patients With Acute Myelogenous Leukemia (AML)

November 26, 2025 updated by: University Health Network, Toronto

Phase I Study of Autologous Acute Myelogenous Leukemia (AML) Cells Containing Lentivirus Engineering Expression of IL-12

This is a phase 1 study (the first stage in testing a new treatment to see how safe and tolerable the treatment is) which will include patients with acute myeloid leukemia (AML) that has either returned or has a more than a 70% chance of coming back and cannot have a bone marrow transplant.

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

9

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 2M9
        • Princess Margaret Centre Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patient with AML and >=18 years of age.
  • 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:

  • Eastern Cooperative Oncology Group (ECOG) performance status >2
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: IL-12
A single dose of IL-12, given intravenously.
Biological: IL-12

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of side effects by type and severity
Time Frame: 2 years
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of time patient is alive
Time Frame: 2 years
2 years
Levels of IL-12
Time Frame: Day 28 to 2 years
For patients who still show evidence of IL-12 producing AML cells on day 28, will be seen weekly for up to 2 years until there is no evidence of IL-12 producing cells
Day 28 to 2 years
Levels of acute myeloid leukemia (AML)
Time Frame: Day 28 to 2 years
For patients who still show evidence of IL-12 producing AML cells on day 28, will be seen weekly for up to 2 years until there is no evidence of IL-12 producing cells
Day 28 to 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Health Network, Toronto

Collaborators

Ozmosis Research Inc.

Investigators

  • Principal Investigator: Hassan Sibai, M.D., Princess Margaret Cancer Centre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2015

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

August 1, 2026

Study Registration Dates

First Submitted

June 24, 2015

First Submitted That Met QC Criteria

June 25, 2015

First Posted (Estimated)

June 26, 2015

Study Record Updates

Last Update Posted (Actual)

December 1, 2025

Last Update Submitted That Met QC Criteria

November 26, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DDP-IL-12
  • OZM-068 (Other Identifier: Ozmosis Research Inc.)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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