AuthorisedHuman Pharmacology (Phase I)- OtherInterventional

Single-centre Phase I/II study with dose escalation of tocilizumab in combination with venetoclax and azacitidine chemotherapy in patients with Acute Myeloid Leukaemia (AML): TOCIVENA

This is a early-stage study for adults with Acute Myeloid Leukaemia (AML), a serious blood cancer. Doctors are trying a new treatment approach that combines three different medications: tocilizumab, venetoclax, and azacitidine. Tocilizumab is a drug that helps control the body's immune response, while venetoclax and azacitidine are commonly used to treat AML. The study aims to find the safest and most effective dose of this combination. This is a "Phase I/II" study, meaning researchers are first checking the treatment's safety and then looking for signs that it might help patients. It's an important step in finding better treatments for AML.

At a glance

Status

Authorised

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Centre Hospitalier Universitaire De Nantes

Enrolment target

Start

10 Apr 2026

Acute Myeloblastic Leukemia

What is this study about?

This research study, called TOCIVENA, is focused on finding new and better ways to treat a specific type of blood cancer called Acute Myeloid Leukaemia (AML). AML is a serious condition where the body makes too many abnormal white blood cells.

In this study, doctors are investigating whether giving three different medications together could be more effective than current treatments. The three medicines are tocilizumab, venetoclax, and azacitidine. Venetoclax and azacitidine are drugs already used to treat AML. Tocilizumab is an interesting addition because it works by calming down parts of the body's immune system, which might help other treatments work better or reduce side effects.

The main goal of this study is to carefully test different doses of this three-drug combination to find the safest amount that can also show signs of working well against AML. This is an early-stage study, so it’s about gathering information to help design bigger studies in the future. Finding effective new treatments for AML is really important for patients, and studies like this help move that forward.

Key takeaways

It's a study for adults with Acute Myeloid Leukaemia (AML).
It's testing a new combination of three existing medicines.
The main goals are to find a safe dose and see how well it works.
It's an early-stage study, paving the way for future research.
You'll be closely monitored by a medical team if you take part.

Who may be eligible?

This study is looking for adults who have been diagnosed with Acute Myeloid Leukaemia (AML). There isn't an upper age limit mentioned, so it's open to adults of various ages.

To be considered for the study, you would need to meet certain health criteria that the doctors would check. This is to make sure the treatment is as safe as possible for you and that the study results are clear.

Both men and women can take part in this research. Your doctor would discuss all the specific requirements with you to see if this study might be a good fit.

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 an adult aged 18 or over?
Have you been diagnosed with Acute Myeloid Leukaemia (AML)?
Are you able to travel to the study centre for regular appointments?
Are you willing to undergo regular medical tests and check-ups?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive the combination of tocilizumab, venetoclax, and azacitidine as prescribed by the study doctors. The study will involve regular visits to the hospital for treatment, check-ups, and tests like blood samples or other procedures to see how you are responding to the medicines and to monitor your health. The duration of your participation would depend on how you respond to the treatment and the study plan, which your care team will explain in detail. There will also be follow-up appointments after the main treatment period to keep an eye on your health.

Potential risks and benefits

Taking part in this study might offer the potential benefit of trying a new treatment combination for AML that isn't widely available yet. It could also help researchers learn more about fighting this disease, which could help future patients. However, like all medicines, the drugs used in this study can have side effects, and some may be serious. The doctors and nurses will carefully monitor you for any side effects and will explain all known risks before you decide to join. Remember, you can choose to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
France

Common questions

What is Acute Myeloid Leukaemia (AML)?

AML is a type of cancer that affects the blood and bone marrow, the soft, spongy tissue inside bones where blood cells are made.

What kind of study is this?

This is an early-stage study (Phase I/II) where doctors are testing the safety of new drug combinations and looking for early signs of how well they might work.

Are the drugs in the study new?

While venetoclax and azacitidine are used to treat AML, tocilizumab is not typically licensed for AML. This study is looking at using them together in a new way.

Will I get a placebo (dummy treatment)?

No, all participants in this study will receive the active study drugs. This study is focused on finding the right dose of the drug combination.

Where is this study taking place?

This is a 'single-centre' study, meaning it's being conducted at one specific hospital or medical centre.