Tests ivosidenib with azacitidine in adults with a leukemia gene mutation
Tests ivosidenib with azacitidine in adults newly diagnosed with IDH1-mutated acute myeloid leukemia.
Plain-language title generated from the registry record
Registry title: An Open-label Phase 3b Study of Ivosidenib in Combination With Azacitidine in Adult Patients Newly Diagnosed With IDH1m Acute Myeloid Leukemia (AML) Ineligible for Intensive Induction Chemotherapy.
Key facts
- Where
- Athens, GreeceSee the 2 sites
- Phase
- Phase 3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- How old are you?
- Has your leukemia (AML) been treated yet? Please do not count hydroxyurea (a tablet that lowers white blood cell counts) or leukapheresis (a machine that filters extra white blood cells out of your blood).
- Has your doctor said you cannot have intensive chemotherapy (very strong chemotherapy given in hospital)?
- Has a lab test found a change (mutation) in the IDH1 gene in your leukemia?
- Do you have serious heart disease, such as a recent heart attack or heart failure?
- Are you pregnant or breastfeeding?
Source: NCT05907057, who can take part
Where in Greece
- Laiko General Hospital of AthensAthens, GreeceNo longer taking part
- University General Hospital AttikonAthens, GreeceNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Servier Affaires Médicales
- Trial code
- NCT05907057EU 2022-501709-11-00
- Record updated
- 8 May 2026
- Original description
The purpose of this study is to learn more about the safety and efficacy of ivosidenib taken with azacitidine to treat adult patients with acute myeloid leukemia (AML) who are presenting a gene mutation called IDH1 (isocitrate dehydrogenase1 mutation-positive [IDH1m]) and cannot receive treatment with intensive chemotherapy (IC).Read full original descriptionShow less
A Single Arm, Open-label Phase 3b Study to Describe the Safety and Tolerability of Ivosidenib in Combination With Azacitidine in Adult Patients Newly Diagnosed With IDH1m Acute Myeloid Leukemia (AML) Ineligible for Intensive Induction Chemotherapy
The purpose of this study is to learn more about the safety and efficacy of ivosidenib taken with azacitidine to treat adult patients with acute myeloid leukemia (AML) who are presenting a gene mutation called IDH1 (isocitrate dehydrogenase1 mutation-positive [IDH1m]) and cannot receive treatment with intensive chemotherapy (IC).
Inclusion: Has untreated Acute Myeloid Leukemia (AML); Have a documented IDH1 R132 gene-mutated disease; Have at least one of the following making yourself ineligible for intensive chemotherapy (IC): 75 years or older, Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 2, or any comorbidity that the investigator judges to be incompatible with IC including but not limited to severe cardiac or pulmonary disorder, creatinine clearance less than 45 mL/minute, or bilirubin greater than 1.5 times the upper limit of normal; Has adequate hepatic (liver) and renal (kidney) function; Female participants of reproductive potential must have a negative blood pregnancy test and must use effective contraception during treatment and for at least 6 months following treatment; Fertile male participants with female partners of reproductive potential must use effective contraception during treatment and for at least 3 months following treatment.
Exclusion: Has received prior treatment with an IDH1 inhibitor; Has had significant active cardiac disease within 6 months prior to the start of study treatment, including Class III or IV congestive heart failure, myocardial infarction (heart attack), unstable angina (chest pain), and/or stroke; Has an active, uncontrolled, systemic fungal, bacterial, or viral infection (including human immunodeficiency virus [HIV], active hepatitis B (HBV), or hepatitis C virus [HCV]) without improvement despite appropriate antibiotics, antiviral therapy, and/or other treatment; Has dysphagia (difficulty swallowing), short-gut syndrome, gastroparesis (stomach paralysis), or any other condition that limits the ingestion or gastrointestinal absorption of orally administered drugs; Has uncontrolled hypertension (high blood pressure); Has received any prior treatment for AML, with the exception of hydroxyurea or leukapheresis for white blood cell count control; Is a woman who is pregnant or breastfeeding.