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.

Launched by SERVIER AFFAIRES MÉDICALES · Jun 8, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at a new combination treatment for adults with a type of blood cancer called acute myeloid leukemia (AML), specifically for those with a certain gene mutation known as IDH1. The study is testing two medications: ivosidenib and azacitidine, to see how safe and effective this treatment is for patients who are not able to receive stronger chemotherapy. This trial is open to adults aged 65 and older, as well as younger patients with certain health conditions that make intensive chemotherapy unsafe for them.

To be eligible for this study, participants must have recently been diagnosed with untreated AML and have the IDH1 gene mutation. They should also have health issues that prevent them from undergoing intensive chemotherapy, such as being 75 years or older or having other serious health conditions. Participants in the trial can expect to take the medications as part of their treatment plan, and the study will closely monitor their health and any side effects. It’s important for potential participants to discuss their individual health situations with their doctor to see if this trial is a good option for them.

Gender

ALL

Eligibility criteria

• 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)