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.

PHASE3RecruitingINTERVENTIONAL
Enrollment

245

Participants

Timeline

Start Date

June 14, 2023

Primary Completion Date

January 1, 2026

Study Completion Date

December 15, 2026

Conditions
Acute Myeloid Leukemia (AML)
Interventions
DRUG

Ivosidenib 500mg Oral Tablet

Provided as tablets, taken orally as two 250mg tablets once daily.

DRUG

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.

Trial Locations (15)

1090

COMPLETED

AKH - Medizinische Universität Wien, Vienna

4600

COMPLETED

Klinikum Wels-Grieskirchen GmbH, Wels

13273

RECRUITING

Institut Paoli Calmettes, Marseille

14033

RECRUITING

CHU CAEN - Hôpital de la Côte de Nacre, Caen

16132

RECRUITING

IRCCS Ospedale Policlinico San Martino, Genova

25123

RECRUITING

Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Spedali Civili), Brescia

31059

RECRUITING

CHU de Toulouse pt, Toulouse

35033

NOT_YET_RECRUITING

CHU Rennes - Hopital Pontchaillou, Rennes

47014

RECRUITING

"IRCCS Istituto Scientifico Romagnolo Per Lo Studio Dei Tumori Dino Amadori - IRST", Meldola

49100

NOT_YET_RECRUITING

CHU Angers - Hôpital Hôtel Dieu, Angers

06135

RECRUITING

Azienda Ospedaliera di Perugia Ospedale S. Maria della Misericordia, Perugia

3818 AZ

RECRUITING

Meander Medisch Centrum, Amersfoort

1105 AZ

RECRUITING

Amsterdam UMC, Amsterdam

6815 AD

NOT_YET_RECRUITING

Rijnstate, Arnhem

9713 GZ

RECRUITING

Universitair Medisch Centrum Groningen, Groningen

All Listed Sponsors
lead

Servier Affaires Médicales

INDUSTRY