Phase 3 Leukaemia Trial, Recruiting
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
- People who have been diagnosed with Acute Myeloid Leukemia (AML) that has not yet been treated
- People whose AML has a specific gene change called IDH1 R132
- People who are considered unsuitable for intensive chemotherapy due to at least one of the following: being 75 years of age or older, having a low physical functioning score (ECOG PS of 2), or having a serious health condition such as severe heart or lung disease, poor kidney function, or abnormal liver enzyme levels (confirm with trial site)
- People who have adequate liver and kidney function at the time of enrolment
- Women who could become pregnant must have a negative blood pregnancy test before joining and must use effective contraception during treatment and for at least 6 months after treatment ends
- Men who could father a child must use effective contraception during treatment and for at least 3 months after treatment ends
Who may not be able to join:
- People who have already received treatment for AML, except for medications used only to control high white blood cell counts (hydroxyurea or leukapheresis)
- People who have previously been treated with an IDH1 inhibitor medication
- Women who are currently pregnant or breastfeeding
- People who have an active, uncontrolled infection — such as a fungal, bacterial, or viral infection including HIV, active hepatitis B, or hepatitis C — that has not improved despite appropriate treatment
- People who have had a serious heart condition in the 6 months before the trial, including severe heart failure, a heart attack, unstable chest pain, or a stroke
- People who have difficulty swallowing, problems absorbing food or medication through their digestive system, or any condition that prevents them from taking tablets or capsules by mouth
- People who have uncontrolled high blood pressure
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Contact this trial
Phone: +33 1 55 72 60 00
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
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Trial details
Where this trial is recruiting
Primary endpoints
Number of Adverse Events (AEs); Number of Serious Adverse Events (SAEs); Differentiation Syndrome of Grade 2 or higher; Number of Adverse Events (AEs) leading to ivosidenib + azacitidine discontinuation; Number of Adverse Events (AEs) leading to ivosidenib + azacitidine interruption; Number of Adverse Events (AEs) leading to ivosidenib + azacitidine dose reduction; Number of Adverse Events (AEs) leading to death; Number of clinical laboratory anomalies assessed as Adverse Events (AEs); Number of patients requiring transfusion (platelet and RBC) and the average number of units transfused; Rate...
Can't join this trial?
Data last synced from ClinicalTrials.gov: 20 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.