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

Last updated: January 30, 2025
Sponsor: University Health Network, Toronto
Overall Status: Active - Not Recruiting

Phase

1

Condition

Acute Myeloid Leukemia

Platelet Disorders

Leukemia

Treatment

IL-12

Clinical Study ID

NCT02483312
DDP-IL-12
OZM-068
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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 stablewhite blood cell count and are not receiving any chemotherapy or desiring furtherintensive treatment.

  • Less than 10% blast cells in the bone marrow following induction or re-inductiontherapy 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

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-drugtherapies with the intent of altering the immune response or kill leukemic cellswithin one week prior to infusion of IL-12, except azacytidine.

  • Patients who are HIV positive.

Study Design

Total Participants: 9
Treatment Group(s): 1
Primary Treatment: IL-12
Phase: 1
Study Start date:
September 01, 2015
Estimated Completion Date:
August 31, 2025

Connect with a study center

  • Princess Margaret Centre Centre

    Toronto, Ontario M5G 2M9
    Canada

    Site Not Available

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