Treatment for adults with IDH1 mutation-positive acute myeloid leukemia who can't undergo intensive chemotherapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• 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

Study contacts

• Study coordinator: Servier Affaires Médicales
• Email: scientificinformation@servier.com
• Phone: +33 1 55 72 60 00

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• PBSS1113 with azacitidine for AML and higher-risk MDS

  This study tests PBSS1113 together with azacitidine to see if it is safe and may help people with AML or higher-risk MDS who are newly diagnosed and not fit for intense chemotherapy or who have relapsed/refractory disease.

  Recruiting Phase 1/2 Chaser Therapeutics, Inc. · Hangzhou, Zhejiang · NCT07761533

• Caris Chromoseq data collection for AML, MDS, and MPN

  This study tests how well the Caris Chromoseq assay helps categorize risk in patients with AML, MDS, or MPN compared with standard tests.

  Recruiting Caris Science, Inc. · Phoenix, Arizona · NCT07680868

• Venetoclax TDM in newly diagnosed AML: exposure and prognosis

  This study checks if measuring venetoclax levels and adjusting treatment helps people with newly diagnosed AML who are getting VEN-AZA.

  Recruiting The First Affiliated Hospital of Soochow University · Suzhou · NCT07670130

• CAR-T cells targeting CD33 and CLL1 for relapsed or refractory AML

  A one-arm early-stage trial tests whether a patient’s own engineered CAR-T cells (ICG415) can be safely given after conditioning chemotherapy to see if they can help adults with relapsed or refractory AML.

  Recruiting at 2 sites Phase 1 iCell Gene Therapeutics · Nanchang, Jiangxi and 1 other locations · NCT07668557

• Ziftomenib for relapsed/refractory NPM1-mutated AML in Japanese adults

  This study will test whether ziftomenib can help adults with relapsed or refractory NPM1-mutated AML who have few other options.

  Recruiting at 15 sites Phase 2 Kyowa Kirin Co., Ltd. · Chiba and 19 other locations · NCT07623616

• VABu Conditioning for elderly AML patients undergoing stem cell transplant

  This trial tests a VABu conditioning regimen to see if it helps older AML patients before allogeneic stem cell transplantation.

  Recruiting Phase 2/3 The First Affiliated Hospital of Soochow University · Suzhou, Jiangsu · NCT07583888

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.