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.
NCT ID: NCT05907057
Last Updated: 2025-04-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
245 participants
INTERVENTIONAL
2023-06-14
2026-12-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Open-Label Ivosidenib in combination with Azacitidine
All participants will receive both Ivosidenib and Azacitidine for a maximum of 28 cycles. Each cycle will be 4 weeks or 28 days long. Ivosidenib will be taken continuously throughout each cycle and Azacitidine will be taken only for 7 days at the beginning of each cycle.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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 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)
18 Years
ALL
No
Sponsors
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Servier Affaires Médicales
INDUSTRY
Responsible Party
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Locations
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AKH - Medizinische Universität Wien
Vienna, , Austria
Klinikum Wels-Grieskirchen GmbH
Wels, , Austria
Institut Paoli Calmettes
Marseille, Bouches-du-Rhône, France
CHU CAEN - Hôpital de la Côte de Nacre
Caen, Calvados, France
CHU de Toulouse pt
Toulouse, Haute Garonne, France
CHU Rennes - Hopital Pontchaillou
Rennes, Ille et Vilaine, France
CHU Angers - Hôpital Hôtel Dieu
Angers, Liore, France
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Spedali Civili)
Brescia, Brescia, Italy
IRCCS Istituto Scientifico Romagnolo Per Lo Studio Dei Tumori "Dino Amadori" - IRST
Meldola, Forli-Cesena, Italy
IRCCS Ospedale Policlinico San Martino
Genova, Genova, Italy
Azienda Ospedaliera di Perugia Ospedale S. Maria della Misericordia
Perugia, Perugia, Italy
Meander Medisch Centrum
Amersfoort, , Netherlands
Amsterdam UMC
Amsterdam, , Netherlands
Rijnstate
Arnhem, , Netherlands
Universitair Medisch Centrum Groningen
Groningen, , Netherlands
Countries
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Central Contacts
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Other Identifiers
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2022-501709-11
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
DIM-95031-006
Identifier Type: -
Identifier Source: org_study_id
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