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

Phase 1

Active, not recruiting

• Conditions: Acute Myeloid Leukemia
• Interventions: Biological: IL-12

• Registration Number: NCT02483312
• Lead Sponsor: University Health Network, Toronto

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-06-24
• Study First Submitted QC: 2015-06-25
• Study First Posted: 2015-06-26
• Study Start: 2015-09
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-30
• Last Update Posted: 2025-02-03
• Primary Completion: 2025-08
• Study Completion: 2025-08

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 9

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
IL-12	IL-12	A single dose of IL-12, given intravenously.

Primary Outcome Measures

Name	Time	Method
Number of side effects by type and severity	2 years

Secondary Outcome Measures

Name	Time	Method
Levels of acute myeloid leukemia (AML)	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
Length of time patient is alive	2 years
Levels of IL-12	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

Trial Locations

Locations (1)

Princess Margaret Centre Centre; 🇨🇦 Toronto, Ontario, Canada