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.

Plain-language summary

This study evaluates the drug Ivosidenib combined with Azacitidine in adults newly diagnosed with acute myeloid leukemia (AML) who carry an IDH1 (R132) gene mutation and are not eligible for intensive chemotherapy. It enrolls adults who have not received prior AML treatment and are ineligible for intensive chemotherapy (for example, aged 75 or older). It is in Phase 3 and is currently recruiting.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Phase 3

Status

Recruiting

Sponsor

Servier Affaires Médicales

Intervention

Ivosidenib 500mg Oral Tablet, Azacitidine

Start date

6/14/2023

Estimated completion

10/15/2027

Countries

Austria, France, Italy, Netherlands

Related genes

Locations

• Vienna, Austria
• Wels, Austria
• Marseille, France
• Caen, France
• Toulouse, France
• Rennes, France
• Angers, France
• Meldola, Italy
• Brescia, Italy
• Genova, Italy
• Perugia, Italy
• Amersfoort, Netherlands
• Amsterdam, Netherlands
• Arnhem, Netherlands
• Groningen, Netherlands

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

Inclusion Criteria:

* 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 Criteria:

* Has received any prior treatment for AML, with the exception of hydroxyurea or leukapheresis for white blood cell count control
* Has received prior treatment with an IDH1 inhibitor
* Is a woman who is pregnant or breastfeeding
* 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 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 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)