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NCT Number: NCT02483312

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Acute Myeloid Leukemia Disease Attributes Hematologic Diseases Hemic and Lymphatic Diseases Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Neoplasms Neoplasms by Histologic Type Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Princess Margaret Centre Centre

Toronto, Ontario, M5G 2M9, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

IL-12

Biological

Primary outcomes

  1. Number of side effects by type and severity

    Time frame: 2 years

Secondary outcomes

  1. 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

  2. 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

  3. Length of time patient is alive

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Collaborators

  • Ozmosis Research Inc.

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2026
Study completion
2026
First posted
Jun 26, 2015
Registry last updated
Dec 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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