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

NCT02483312 | Active Not Recruiting Phase 1 DMC

• 2 other identifiers: DDP-IL-12OZM-068
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Acute Myeloid Leukemia

Keywords

Recurrent

Outcome Measures

Primary Outcomes (1)

• Number of side effects by type and severity

  2 years

Secondary Outcomes (3)

• Levels of IL-12

  Day 28 to 2 years

• Levels of acute myeloid leukemia (AML)

  Day 28 to 2 years

• Length of time patient is alive

  2 years

Study Arms (1)

IL-12

EXPERIMENTAL

A single dose of IL-12, given intravenously.

Biological: IL-12

Interventions

IL-12 BIOLOGICAL

IL-12

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Health Network, Toronto: lead
• Ozmosis Research Inc.: collaborator

Study Sites (1)

Princess Margaret Centre Centre

Toronto, Ontario, M5G 2M9, Canada

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Acute; Recurrence

Interventions

Interleukin-12

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Interleukins; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• Hassan Sibai, M.D.

  Princess Margaret Cancer Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2015
• First Posted: June 26, 2015
• Study Start: September 1, 2015
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: December 1, 2025

Record last verified: 2025-11

Locations

CA (1)