Acute Myeloid Leukemia
Conditions
Keywords
Recurrent
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.
Interventions
BIOLOGICALIL-12
Sponsors
Ozmosis Research Inc.
University Health Network, Toronto
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of side effects by type and severity | 2 years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 | — |
Countries
Canada
Outcome results
None listed