Treatment for adults with IDH1 mutation-positive acute myeloid leukemia who can't undergo intensive chemotherapy
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
This study is testing if a combination of two medications can help adults with a specific type of leukemia who can't have strong chemotherapy.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 245 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Servier Industry-sponsored |
| Drugs / interventions | chemotherapy |
| Locations | 15 sites (Vienna and 14 other locations) |
| Trial ID | NCT05907057 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and efficacy of ivosidenib combined with azacitidine in adult patients newly diagnosed with acute myeloid leukemia (AML) who have the IDH1 mutation and are ineligible for intensive chemotherapy. Participants will receive ivosidenib daily and azacitidine for the first seven days of each 28-day treatment cycle. Regular assessments, including physical exams and blood work, will be conducted throughout the study, which is expected to continue until 2026. After treatment, participants will be monitored for survival every 12 weeks.
Who should consider this trial
Good fit: Ideal candidates include adults with untreated IDH1 mutation-positive AML who are ineligible for intensive chemotherapy due to age or comorbidities.
Not a fit: Patients with AML who are eligible for intensive chemotherapy or do not have the IDH1 mutation may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with a specific genetic mutation in AML who cannot tolerate standard chemotherapy.
How similar studies have performed: Other studies have shown promising results with similar combinations of targeted therapies and hypomethylating agents in AML, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Vienna and 14 other locations
- AKH - Medizinische Universität Wien — Vienna, Austria (Completed)
- Klinikum Wels-Grieskirchen GmbH — Wels, Austria (Completed)
- Institut Paoli Calmettes — Marseille, Bouches-du-Rhône, France (Recruiting)
- CHU CAEN - Hôpital de la Côte de Nacre — Caen, Calvados, France (Recruiting)
- CHU de Toulouse pt — Toulouse, Haute Garonne, France (Recruiting)
- CHU Rennes - Hopital Pontchaillou — Rennes, Ille Et Vilaine, France (Not_yet_recruiting)
- CHU Angers - Hôpital Hôtel Dieu — Angers, Liore, France (Not_yet_recruiting)
- IRCCS Istituto Scientifico Romagnolo Per Lo Studio Dei Tumori "Dino Amadori" - IRST — Meldola, Forli-Cesena, Italy (Recruiting)
- Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Spedali Civili) — Brescia, Italy (Recruiting)
- IRCCS Ospedale Policlinico San Martino — Genova, Italy (Recruiting)
- Azienda Ospedaliera di Perugia Ospedale S. Maria della Misericordia — Perugia, Italy (Recruiting)
- Meander Medisch Centrum — Amersfoort, Netherlands (Recruiting)
- Amsterdam UMC — Amsterdam, Netherlands (Recruiting)
- Rijnstate — Arnhem, Netherlands (Not_yet_recruiting)
- Universitair Medisch Centrum Groningen — Groningen, Netherlands (Recruiting)
Study contacts
- Study coordinator: Servier Affaires Médicales
- Email: scientificinformation@servier.com
- Phone: +33 1 55 72 60 00
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.