Clinical Trials in Italy / NCT05907057
Recruiting
Phase 3
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.
NCT05907057 · tracked via the Priya Life Science Italy tracker
Condition(s) studied
Acute Myeloid Leukemia (AML)
Investigational drug(s) / intervention(s)
Ivosidenib 500mg Oral Tablet: Provided as tablets, taken orally as two 250mg tablets once daily.
Azacitidine: Administered subcutaneously (SC) or intravenously (IV) at a dose of 75mg/m2/day for 7 days, either consecutively on Days 1-7 or discontinuously for Days 1-5 and 8-9 of each cycle. The 7 days of administration will occur at the beginning of every 4 week-long cycle.
Study summary
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).
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)
Primary outcome measure(s)
- Number of Adverse Events (AEs) — up to week 116
Adverse events (AEs) will be graded according to the CTCAE v5.0 - Number of Serious Adverse Events (SAEs) — up to week 116
Adverse events (AEs) will be graded according to the CTCAE v5.0 - Differentiation Syndrome of Grade 2 or higher — up to week 116
- Number of Adverse Events (AEs) leading to ivosidenib + azacitidine discontinuation — up to week 112
- Number of Adverse Events (AEs) leading to ivosidenib + azacitidine interruption — up to week 112
- Number of Adverse Events (AEs) leading to ivosidenib + azacitidine dose reduction — up to week 112
- Number of Adverse Events (AEs) leading to death — up to week 116
- Number of clinical laboratory anomalies assessed as Adverse Events (AEs) — up to week 116
- Number of patients requiring transfusion (platelet and RBC) and the average number of units transfused — up to week 116
- Rate of infections — up to week 116
Infection rates will be summarized by classification and will include a count and proportion. - QT Prolongation event assessed as Grade 3 or higher — up to week 116
Trial sites (15)
| Facility | City | Region | Status |
|---|---|---|---|
| AKH - Medizinische Universität Wien | Vienna | Austria | Completed |
| Klinikum Wels-Grieskirchen GmbH | Wels | Austria | Completed |
| Institut Paoli Calmettes | Marseille | Bouches-du-Rhône | Recruiting |
| CHU CAEN - Hôpital de la Côte de Nacre | Caen | Calvados | Recruiting |
| CHU de Toulouse pt | Toulouse | Haute Garonne | Recruiting |
| CHU Rennes - Hopital Pontchaillou | Rennes | Ille Et Vilaine | Not Yet Recruiting |
| CHU Angers - Hôpital Hôtel Dieu | Angers | Liore | Not Yet Recruiting |
| IRCCS Istituto Scientifico Romagnolo Per Lo Studio Dei Tumori "Dino Amadori" - IRST | Meldola | Forli-Cesena | 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 |
More Servier Affaires Médicales trials in Italy
Other trials for the same condition
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05907057 on ClinicalTrials.gov ↗ ← All trials in Italy