Active not recruitingPHASE1INTERVENTIONAL

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

This is a new study for adults with a type of blood cancer called acute myeloid leukaemia (AML). It's a 'Phase 1' trial, which means the main goal is to check if a new treatment is safe and how well people can tolerate it. This study is for people whose AML has come back or is very likely to return, and who cannot have a bone marrow transplant. The researchers are exploring a treatment where they take some of your own AML cells, modify them in a lab to produce a protein called IL-12, and then give them back to you. They want to see if this method is safe and could be a useful way to fight AML in people who don't have other transplant options. The study is open to anyone aged 18 or over. It's an early step in developing new treatments.

At a glance

Status

Active not recruiting

Phase

PHASE1

Sponsor

University Health Network, Toronto

Enrolment target

Start

01 Sep 2015

Estimated completion

01 Aug 2026

Acute Myeloid Leukemia

What is this study about?

This study is about finding new ways to treat acute myeloid leukaemia, often called AML. AML is a type of cancer that affects the blood and bone marrow. This particular study is in its very first stage, called Phase 1. In Phase 1 studies, doctors are mainly focused on making sure a new treatment is safe for people and figuring out the right dose, rather than checking how well it works.

The treatment being tested involves a protein called Interleukin-12 (IL-12). Researchers will take some of a patient's own AML cells, change them in a laboratory so they produce IL-12, and then put these modified cells back into the body. The idea is that these cells might then help the body's immune system fight the cancer. This method is being explored for people with AML who are in remission (meaning the cancer is not currently active) but at high risk of it coming back, or for those whose AML has returned and who can't have a bone marrow transplant, which is usually a standard treatment option for AML.

In simple terms, they're trying to teach the cancer cells to help fight themselves by making a particular protein. If this very early stage shows the treatment is safe, it could open the door for more studies in the future to see how effective it is. It's an important step in developing potential new therapies for AML.

Key takeaways

This is an early-stage (Phase 1) study for adults with acute myeloid leukaemia (AML).
It tests a new approach using modified AML cells to produce a protein called IL-12.
The main goal is to check the treatment's safety and how well people tolerate it.
It's for people whose AML has returned or is high-risk, and who cannot have a bone marrow transplant.
Participation involves regular monitoring and assessments.
You can stop taking part at any time without affecting your future medical care.

Who may be eligible?

To join this study, you need to be an adult, aged 18 or older, with acute myeloid leukaemia (AML). Your AML cells must be suitable for modification in the lab. You must either be in remission (where your cancer is currently under control), but with a high chance of it coming back, or have had treatment previously and stable blood counts, even if not fully in remission, and not be having intensive chemotherapy right now. Your bone marrow also needs to have less than 10% 'blast cells' (immature cancer cells) after your last treatment.

You also need to be well enough generally to take part, with healthy kidney and liver function tests. Women must not be pregnant, and both men and women will need to agree to use contraception during the study. You also need to be able to follow the study instructions carefully.

There are also some reasons why you might not be able to join. For example, if you have a serious ongoing infection, certain brain or spinal cord conditions, or if more than 10% of your bone marrow cells are blast cells. You also can't be taking certain medications that affect your immune system or kill cancer cells within a week before starting the study treatment (except for one specific drug called azacytidine). People with HIV are also not able to participate. Your doctor will carefully check all these requirements to see if this study is an option for you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have a diagnosis of Acute Myeloid Leukaemia (AML)?
Are you currently in remission with high risk of relapse, or have you had prior treatment and your white blood cell count is stable?
Do you currently have less than 10% 'blast cells' in your bone marrow?
Are your kidney and liver test results within acceptable limits?
Are you able to use contraception if needed, and are you not pregnant?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, the first step will be to give your full agreement. Doctors will then collect some of your AML cells. These cells will be sent to a lab where they'll be specially prepared to produce the IL-12 protein. Once your modified cells are ready, you'll receive them back into your body. This will be an infusion, similar to a drip.

Throughout the study, you'll have regular visits to the hospital or clinic. During these visits, the medical team will monitor your health closely, take blood samples, and perform other tests to check how you're responding to the treatment and to make sure it's safe. They will also be looking for any side effects. The exact number of visits and tests will be explained to you, but typically, Phase 1 studies involve frequent check-ups, especially in the beginning. You will also need to use contraception regularly during your participation. The study team will explain the total duration of your involvement.

Potential risks and benefits

Like all medical studies, there are potential benefits and risks to consider. A potential benefit of taking part in this study is that you would receive a new, experimental treatment for your AML that is not yet widely available. While the main goal of this early-stage study is safety, there is a chance the treatment could help your condition, especially if other standard treatments are not an option for you. However, it's important to remember that this is a first-stage trial, and we don't yet know how effective it will be. There are also potential risks involved. The main purpose of this study is to identify and understand new potential risks, so you might experience side effects from the IL-12 or the process of modifying and returning the cells. These side effects could range from mild to severe, and they will be carefully monitored by the study team. You will be given more detailed information about possible side effects before you decide to join. It's very important to remember that participating in any clinical trial is always voluntary. You have the right to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (1)

Princess Margaret Centre Centre
Verified postcode
Toronto, Canada

Common questions

What is AML?

AML stands for Acute Myeloid Leukaemia. It's a fast-growing cancer of the blood and bone marrow.

What is a Phase 1 study?

A Phase 1 study is the very first stage of testing a new treatment in people. The main aim is to see if it's safe and to find the right dose, rather than how well it works.

What is IL-12?

IL-12 is a protein that the body naturally produces. In this study, your own AML cells will be modified to produce IL-12, potentially to help your immune system fight the cancer.

Can I receive this treatment if I don't have AML?

No, this study is specifically designed for adult patients who have been diagnosed with acute myeloid leukaemia (AML).

What if I change my mind after joining?

You are free to leave the study at any time, for any reason, without it affecting your care.