AuthorisedTherapeutic exploratory (Phase II)Interventional

A Phase II, Open-Label Randomized Study of Intravenous Tambiciclib in Combination with the Standard of care Venetoclax and Azacitidine in Patients with Newly Diagnosed AML Who Failed to Achieve at Least MLFS After the First Two Cycles of Treatment with Venetoclax and Azacitidine Alone

This research study is for adults with a type of blood cancer called acute myeloid leukaemia (AML). If your AML treatment with Venetoclax and Azacitidine hasn't worked as well as hoped after the first two cycles, this study might be for you. It's testing a new drug called Tambiciclib, which is given into a vein, alongside the standard medicines you're already receiving. The main goal is to find out if adding Tambiciclib helps more patients respond to the treatment. Researchers will also be checking for any side effects and how long patients live after starting the study. This is a Phase II study, meaning it's exploring if the new drug combination is effective and safe before potentially moving on to larger trials.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l., IIS La Fe

Enrolment target

Start

19 May 2026

Acute myeloid leukemia

What is this study about?

This study is designed for individuals who have recently been diagnosed with acute myeloid leukaemia (AML). AML is a type of cancer that starts in the bone marrow, where blood cells are made, and quickly affects the blood. The usual approach to treating AML often includes medications like Venetoclax and Azacitidine.

However, sometimes, after the first two rounds of these standard treatments, the leukaemia doesn't respond as hoped. This study aims to see if adding a new drug, called Tambiciclib, to the existing Venetoclax and Azacitidine treatment can improve the outcome for these patients. Tambiciclib is given through a drip into a vein.

The main thing researchers want to find out is whether adding Tambiciclib leads to more patients showing a good response to the treatment. A good response means that the number of leukaemia cells in the body has significantly reduced or disappeared. They will also keep a close eye on any side effects and understand how long patients live and if their leukaemia comes back.

Key takeaways

This study is for adults with newly diagnosed AML.
It's for people whose initial treatment with Venetoclax and Azacitidine didn't work well enough.
A new drug, Tambiciclib, is being added to the standard treatment.
The main goal is to see if this new combination helps more patients respond to treatment.
Researchers will also monitor for side effects and how long patients live.
It's a Phase II study, exploring effectiveness and safety.

Who may be eligible?

This study is looking for adult patients, meaning anyone 18 years old or older, with newly diagnosed acute myeloid leukaemia (AML). Both men and women can take part in this research.

To be eligible, you must have started treatment with Venetoclax and Azacitidine. Crucially, after completing your first two cycles of this standard treatment, your leukaemia should not have responded adequately. This means your doctors will have assessed your progress and determined that you haven't yet reached a good level of remission or improvement. Your doctor will be able to confirm if you meet this specific criteria.

There will be other detailed health checks to make sure the study treatment is safe for you, so your medical team will go through all the requirements carefully.

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?
Have you been diagnosed with acute myeloid leukaemia (AML)?
Have you started initial treatment with Venetoclax and Azacitidine?
Did your leukaemia not respond as hoped after your first two cycles of Venetoclax and Azacitidine?
Are you willing to receive Tambiciclib by injection into a vein?
Are you able to attend regular hospital visits for treatment and check-ups?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, you will receive Tambiciclib, given as an injection into your vein, in addition to your current Venetoclax and Azacitidine treatment. You'll have regular hospital visits for these treatments and for check-ups. During these visits, the study team will carry out health assessments, which may include blood tests, physical examinations, and other tests to see how you're responding to the treatment and to monitor for any side effects.

The exact number and frequency of visits will be explained to you, but they are likely to be quite regular, especially at the beginning. The study will continue for a period, during which you'll receive the treatment and be closely monitored. Even after treatment stops, there will be follow-up appointments to track your long-term health and the progress of your leukaemia. The total duration of your involvement could vary depending on your response to treatment and the follow-up schedule.

Potential risks and benefits

Participating in this study might offer the potential benefit of improving your response to treatment by adding Tambiciclib to your current medicines, aiming to better control your acute myeloid leukaemia. However, like all medications, Tambiciclib can cause side effects. These could be similar to those you've experienced with your current treatment or could be new ones, ranging from mild to more serious. The study team will explain all known or potential risks in detail. It's important to remember that you are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (2)

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

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Unverified
Italy
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Unverified
Spain

Common questions

What is acute myeloid leukaemia (AML)?

AML is a fast-growing cancer of the blood and bone marrow, where damaged blood cells are produced.

What does a 'Phase II' study mean?

A Phase II study explores if a new medicine or treatment is effective and safe in a slightly larger group of people, after initial safety tests.

What are Venetoclax and Azacitidine?

These are standard medicines often used together to treat acute myeloid leukaemia.

What is Tambiciclib?

Tambiciclib is a new, experimental drug being tested in this study to see if it improves AML treatment.

Will I know if the new drug is working?

The study team will regularly check your blood and bone marrow to see how the leukaemia is responding to the treatment.