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

Acute Myeloid Leukemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02483312
• Other study ID #: DDP-IL-12
• Secondary ID: OZM-068
• Status: Recruiting
• Phase: Phase 1
• Start date: September 2015
• Est. completion date: August 2024

Study information

• Verified date: March 2024
• Source: University Health Network, Toronto
• Contact: Hassan Sibai, M.D.
• Phone: 416-946-4407
• Email: Hassan.Sibai[@]uhn.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 9
• Est. completion date: August 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Myeloid Leukemia
• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute

Intervention

Biological:
• IL-12

Locations

Country	Name	City	State
Canada	Princess Margaret Centre Centre	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
University Health Network, Toronto	Ozmosis Research Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of side effects by type and severity		2 years
Secondary	Levels of IL-12	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
Secondary	Levels of acute myeloid leukemia (AML)	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
Secondary	Length of time patient is alive		2 years