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

University Health Network, Toronto

Status and phase

Active, not recruiting

Phase 1

Conditions

Acute Myeloid Leukemia

Treatments

Biological: IL-12

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT02483312

OZM-068 (Other Identifier)

DDP-IL-12

Details and patient eligibility

About

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.

Enrollment

9 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.