NCT02483312Active, not recruitingPhase 1
A Study of (Interleukin-12) IL-12 in Patients With Acute Myelogenous Leukemia (AML)
Phase I Study of Autologous Acute Myelogenous Leukemia (AML) Cells Containing Lentivirus Engineering Expression of IL-12
Source: ClinicalTrials.gov · Last updated 1 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 9 (estimated)
- First submitted
- 24 Jun 2015
- Start date
- Sept 2015
- Primary completion date
- Aug 2026
- Lead sponsor
- University Health Network, Toronto
- Diseases
- Acute myeloid leukemia
- NCT number
- NCT02483312
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 9
- From Sept 2015 to the primary completion date, Aug 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- Known persistent infection
- Known central nervous system (CNS) disease
- Patients who are HIV positive.
Other
- Eastern Cooperative Oncology Group (ECOG) performance status \>2
- Greater than 10% blasts in the bone marrow or circulating blast cells
- Life expectancy \< 2 months
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Princess Margaret Centre Centre Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.