Acute Myeloid LeukemiaPhase 1NCT02483312
A Study of (Interleukin-12) IL-12 in Patients With Acute Myelogenous Leukemia (AML)
A Phase 1 study testing IL-12 in people with Acute Myeloid Leukemia, run by University Health Network, Toronto at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myeloid Leukemia
- What is being tested?
- IL-12
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2015to Aug 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- Acceptable creatinine, Aspartate transaminase (AST), Alkaline phosphatase (ALP), bilirubin lab results.
- Agree to use contraception
- Not pregnant
- Able to comply with study procedures
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase I Study of Autologous Acute Myelogenous Leukemia (AML) Cells Containing Lentivirus Engineering Expression of IL-12
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.
- Conditions
- Acute Myeloid Leukemia
- Being tested
- IL-12
- Keywords
- Recurrent
- Medical subject headings
- Leukemia, Myeloid, Acute, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IL-12Biological
| Study group | Role | What they receive |
|---|---|---|
| IL-12 | Experimental | A single dose of IL-12, given intravenously. Receives: Biological: IL-12 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of side effects by type and severity
Measured: 2 years
Secondary outcomes (3)
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
Measured: Day 28 to 2 years
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
Measured: Day 28 to 2 years
Length of time patient is alive
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2015 (estimated)
- Study startSep 2015
- Primary completionAug 2026 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Ozmosis Research Inc.
- Responsible party
- Sponsor
- Investigators
- Hassan Sibai, M.D., Principal investigator, Princess Margaret Cancer Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02483312
- Sponsor's protocol ID
- DDP-IL-12
- Other IDs
- OZM-068
- Status last verified
- Nov 2025
- First submitted
- 24 Jun 2015
- Last updated
- 1 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study of Autologous Acute Myelogenous Leukemia (AML) Cells Containing Lentivirus Engineering Expression of IL-12
- ClinicalTrials.gov ID
- NCT02483312
- Acronym / sponsor ID
- DDP-IL-12
- Conditions
- Acute Myeloid Leukemia
- Keywords
- Recurrent
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 9 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- Ozmosis Research Inc.
- Study start
- Sep 2015
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 26 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IL-12 | Experimental | Biological: IL-12A single dose of IL-12, given intravenously. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IL-12 | Biological | IL-12 |
Primary outcome
Number of side effects by type and severity
Time frame: 2 years
3 secondary outcomes
Levels of IL-12
Time frame: Day 28 to 2 years
Levels of acute myeloid leukemia (AML)
Time frame: Day 28 to 2 years
Length of time patient is alive
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hassan Sibai, M.D. principal investigator
Princess Margaret Cancer Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing IL-12 in people with Acute Myeloid Leukemia, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 1 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of side effects by type and severity (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2025.