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New combo therapy aims to improve life quality in AML patients too sick for standard chemo

NCT ID NCT06181734

Disease control Sponsor: iOMEDICO AG Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looked at how adults with a specific type of acute myeloid leukemia (AML) who cannot receive standard chemotherapy feel and function while taking a combination of ivosidenib and azacitidine. The main goal was to measure quality of life using questionnaires, along with checking how well the treatment works and its safety. Only 8 patients were enrolled in Germany, making this a very small observational study.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ivosidenib and azacitidine
What this could lead to
If successful, this could show that the combination improves quality of life and controls AML in patients who cannot tolerate standard chemotherapy.
What could go wrong
This is a small, completed observational study with only 8 participants, so results may not apply broadly. It does not test a new treatment but observes real-world use.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

8 people

The number who actually took part.

Started

Dec 2023

Finished

Jul 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Adult patients with newly diagnosed, IDH1 R132- mutated AML who are not eligible to receive standard induction chemotherapy and with treatment decision for ivosidenib in combination with azacitidine according to SmPC.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Age 18 years or older. * Newly diagnosed Acute Myeloid Leukemia (AML). * Having an isocitrate dehydrogenase 1 (IDH1) R132 mutation. * Not eligible to receive standard induction chemotherapy. * Decision for treatment with ivosidenib in combination with azacitidine as per current SmPC. * Signed written informed consent\* \*Patients are allowed to be enrolled up to 6 weeks after ivosidenib plus azacitidine dose * For patients participating in PROs: Willingness and capability to participate in PRO assessment in German language * Other criteria according to current SmPC. Exclusion Criteria: * Participation in an interventional clinical trial within 30 days prior to enrollment or simultaneous participation in an interventional clinical trial except for the follow-up period. * Patients unable to consent * Other contraindications according to current SmPC.

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Conditions

The condition(s) this trial relates to.

acute myeloid leukemia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Acute myeloid leukemia (AML)

Contacts and locations

Locations

  • Praxis für interdisziplinäre Onkologie & Hämatologie

    Freiburg im Breisgau, Germany

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