AuthorisedTherapeutic exploratory (Phase II)Interventional

A phase II, multicentre, open label clinical trial evaluating the efficacy and safety of oral decitabine plus ivosidenib in adult patients with newly diagnosed acute myeloid leukemia older than 60 years old and/or who are ineligible for standard induction chemotherapy

This research study is looking at a new treatment for adults, aged 60 and over, or those who can't receive typical strong chemotherapy, who have recently been diagnosed with acute myeloid leukaemia (AML). The study involves taking two medicines, Tibsovo and Inaqovi, as tablets. Doctors want to see if this combination effectively reduces or clears the leukaemia cells from the body and if it's safe to use. This is a Phase II trial, meaning it's an earlier stage study to understand how well the drugs work and their side effects before they are widely available. It's an important step in finding new ways to help people with AML.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

Fundacion PETHEMA

Enrolment target

Start

19 Feb 2026

Acute myeloid leukemia

What is this study about?

This study is for people who have recently been diagnosed with a type of blood cancer called acute myeloid leukaemia (AML). AML is a serious condition where abnormal white blood cells develop quickly in the bone marrow and prevent the production of healthy blood cells. This study is specifically for older adults, generally over 60, or those who, for health reasons, aren't suitable for the usual strong chemotherapy treatments often given for AML.

The main aim of this research is to see how well two medicines, Tibsovo and Inaqovi, work together. Both are taken as tablets. Researchers want to find out if this combination can effectively clear the leukaemia cells from the body, leading to what doctors call a 'complete response'. They also want to understand if this treatment is safe for people to take and what side effects might occur.

By taking part, you would be helping doctors learn more about potential new treatments for AML. This research is crucial because it helps develop options for patients who might not be able to have standard treatments, and it could improve future care for many others living with this condition.

Key takeaways

This study is testing two new tablet medicines (Tibsovo and Inaqovi) for newly diagnosed AML.
It's for older adults (60+) or those who can't have standard chemotherapy.
The main goals are to see if the treatment clears leukaemia cells and is safe.
Participation involves taking tablets and regular hospital visits for monitoring.
You'll be closely supervised by doctors and nurses throughout your involvement.
You can stop participating at any time without affecting your medical care.

Who may be eligible?

This study is looking for adults who have acute myeloid leukaemia (AML) but only if they have been diagnosed recently and meet certain criteria.

Firstly, you need to be an adult. Secondly, you must either be aged 60 or older, OR your doctors must have decided that you are not suitable for the usual, strong chemotherapy treatments given for AML due to other health reasons. This means the study is focused on finding options for people who might not have many other treatment choices.

The study welcomes both men and women. There would be further checks by the study team to make sure it's the right study for you, depending on your overall health and specific condition.

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.

Have you recently been diagnosed with acute myeloid leukaemia?
Are you aged 60 or older, OR has your doctor said you can't have standard chemotherapy?
Are you an adult (18 years or older)?
Are you able to take medicines in tablet form?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would receive the study drugs, Tibsovo and Inaqovi, as tablets. You would be given instructions on how to take these medicines at home. You will have regular visits to the hospital or clinic so the doctors and nurses can monitor your health, check how you're responding to the treatment, and manage any side effects. These visits will likely involve physical exams, blood tests, and possibly other tests like bone marrow biopsies to see how the leukaemia is responding. You'll also be asked about your overall well-being. The study duration will vary for each person, but you'll have close follow-up for a period after you start the treatment to understand its longer-term effects.

Potential risks and benefits

Taking part in this study may offer potential benefits, such as receiving a new treatment for acute myeloid leukaemia that might be effective, especially if standard treatments aren't suitable for you. You would also receive close medical attention and monitoring. However, like all medicines, the study drugs, Tibsovo and Inaqovi, can have side effects, some of which could be serious. The research team will explain all known risks and potential side effects in detail. You have the right to withdraw from 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
Spain

Common questions

What is acute myeloid leukaemia (AML)?

AML is a fast-growing cancer of the blood and bone marrow, where too many abnormal white blood cells are made and stop healthy blood cells from forming properly.

What are Tibsovo and Inaqovi?

These are the names of two different medicines being tested together in this study. They are both taken as tablets and work in different ways to try and fight the leukaemia cells.

Why is this study only for people over 60 or those who can't have standard chemotherapy?

This study is focused on finding new treatment options for people who might not be able to tolerate typical strong chemotherapy, often due to age or other health conditions.

What is a 'complete response'?

In this study, a complete response means that tests show the leukaemia cells are no longer detectable in your bone marrow and your normal blood counts have returned to healthy levels.

Will I get 'better' if I join this study?

There are no guarantees. The aim is to see if the treatment helps, but like all new medicines, it might not work for everyone. Your doctors will monitor your progress closely.