Actively Recruiting
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.
Led by Servier Affaires Médicales · Updated on 2026-05-08
245
Participants Needed
15
Research Sites
226 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
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.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Has untreated Acute Myeloid Leukemia (AML)
- Has a documented IDH1 R132 gene mutation
- Is 75 years or older, or has an ECOG Performance Status of 2, or has a comorbidity making intensive chemotherapy unsuitable
- Has adequate liver and kidney function
- If female and of reproductive potential, has a negative pregnancy test and uses effective contraception during treatment and for 6 months after
- If male with female partner of reproductive potential, uses effective contraception during treatment and for 3 months after
You will not qualify if you...
- Has received any prior treatment for AML except hydroxyurea or leukapheresis
- Has received prior treatment with an IDH1 inhibitor
- Is pregnant or breastfeeding
- Has an active, uncontrolled systemic infection including HIV, active hepatitis B or C
- Has had significant active cardiac disease in the past 6 months including severe heart failure, heart attack, unstable angina, or stroke
- Has difficulty swallowing or conditions limiting oral drug absorption
- Has uncontrolled high blood pressure
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 15 locations
1
AKH - Medizinische Universität Wien
Vienna, Austria, 1090
Completed
2
Klinikum Wels-Grieskirchen GmbH
Wels, Austria, 4600
Completed
3
Institut Paoli Calmettes
Marseille, Bouches-du-Rhône, France, 13273
Actively Recruiting
4
CHU CAEN - Hôpital de la Côte de Nacre
Caen, Calvados, France, 14033
Actively Recruiting
5
CHU de Toulouse pt
Toulouse, Haute Garonne, France, 31059
Actively Recruiting
6
CHU Rennes - Hopital Pontchaillou
Rennes, Ille Et Vilaine, France, 35033
Not Yet Recruiting
7
CHU Angers - Hôpital Hôtel Dieu
Angers, Liore, France, 49100
Not Yet Recruiting
8
IRCCS Istituto Scientifico Romagnolo Per Lo Studio Dei Tumori "Dino Amadori" - IRST
Meldola, Forli-Cesena, Italy, 47014
Actively Recruiting
9
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Spedali Civili)
Brescia, Italy, 25123
Actively Recruiting
10
IRCCS Ospedale Policlinico San Martino
Genova, Italy, 16132
Actively Recruiting
11
Azienda Ospedaliera di Perugia Ospedale S. Maria della Misericordia
Perugia, Italy, 06135
Actively Recruiting
12
Meander Medisch Centrum
Amersfoort, Netherlands, 3818 AZ
Actively Recruiting
13
Amsterdam UMC
Amsterdam, Netherlands, 1105 AZ
Actively Recruiting
14
Rijnstate
Arnhem, Netherlands, 6815 AD
Not Yet Recruiting
15
Universitair Medisch Centrum Groningen
Groningen, Netherlands, 9713 GZ
Actively Recruiting
Research Team
S
Servier Affaires Médicales
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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