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
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
Number of side effects by type and severity — 2 years
Trial sites (1)
Facility
City
Region
Status
Princess Margaret Centre Centre
Toronto
Ontario
More University Health Network, Toronto trials in Canada
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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