Ivosidenib (IVO) Monotherapy and Azacitidine (AZA) Monotherapy in Patients With Hypomethylating Agent (HMA) Naive Myelodysplastic Syndromes (MDS) With an IDH1 Mutation

PHASE3RecruitingINTERVENTIONAL
Enrollment

48

Participants

Timeline

Start Date

December 3, 2024

Primary Completion Date

November 1, 2027

Study Completion Date

December 1, 2028

Conditions
Hypomethylating Agent (HMA) Naive Myelodysplastic Syndromes (MDS)Myelodysplastic Syndromes (MDS)
Interventions
DRUG

Ivosidenib

Two 250 mg tablets, totaling 500 mg, administered orally once daily until disease relapse or progression, unacceptable toxicity, confirmed pregnancy, undergoing HSCT, death, withdrawal of consent, lost to follow-up, or Sponsor ending the study, whichever occurs first.

DRUG

Azacitidine

Azacitidine 75mg/m\^2/day administered by subcutaneous (SC) or intravenous (IV) injection for 1 week (7 days) of each 4-week (28 day) treatment cycle until disease relapse or progression, unacceptable toxicity, confirmed pregnancy, undergoing HSCT, death, withdrawal of consent, lost to follow-up, or Sponsor ending the study, whichever occurs first.

Trial Locations (52)

2170

NOT_YET_RECRUITING

Liverpool Hospital, Liverpool

2298

NOT_YET_RECRUITING

Calvary Mater Newcastle, Waratah

3076

RECRUITING

Northern Health, Epping

3168

RECRUITING

Monash Health, Clayton

6009

RECRUITING

Sir Charles Gairdner Hospital, Nedlands

8035

NOT_YET_RECRUITING

H. Valle de Hebron, Barcelona

8916

NOT_YET_RECRUITING

Institut Catala D' Oncologia, Badalona

10065

NOT_YET_RECRUITING

MSKCC, New York

10126

NOT_YET_RECRUITING

Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino - Presidio Molinette, Torino

20089

NOT_YET_RECRUITING

Humanitas Research Hospital (Istituto Clinico Humanitas), Milan

27100

NOT_YET_RECRUITING

Fondazione I.R.C.C.S. Policlinico San Matteo, Pavia

27514

NOT_YET_RECRUITING

Unc Lineberger Comprehensive Cancer Center, Chapel Hill

28027

RECRUITING

Clinica Universitaria de Navarra (Madrid), Madrid

31008

RECRUITING

Clinica Universitaria de Navarra (Pamplona), Pamplona

31059

NOT_YET_RECRUITING

Institut Universitaire Du Cancer Toulouse-Oncopole, Toulouse

33600

NOT_YET_RECRUITING

Chu Bordeaux, Hopital Du Haut Leveque, Pessac

37007

RECRUITING

Hospital Clinico Universitario de Salamanca, Salamanca

37075

NOT_YET_RECRUITING

Universitaetsmedizin Goettingen (Umg), Göttingen

40138

NOT_YET_RECRUITING

"Istituto Di Ematologia Lorenzo E Ariosto Seragnoli - Policlinico Di S. Orsola", Bologna

40477

NOT_YET_RECRUITING

Marien Hospital Duesseldorf, Düsseldorf

41009

RECRUITING

Hospital Universitario Virgen de La Macarena, Seville

43210

RECRUITING

Ohio State University Comprehensive Cancer Center, Columbus

44093

NOT_YET_RECRUITING

Chu Nantes-Hotel Dieu, Nantes

46026

RECRUITING

H. Universitario La Fe, Valencia

50139

RECRUITING

Azienda Ospedaliero-Universitaria Careggi, Florence

54500

NOT_YET_RECRUITING

Chu Brabois, Vandœuvre-lès-Nancy

60126

RECRUITING

Azienda Ospedaliero Universitaria Delle Marche, Ancona

60637

NOT_YET_RECRUITING

University of Chicago, Duchossois Center for Advanced Medicine (DCAM), Chicago

75010

NOT_YET_RECRUITING

Hopital Saint Louis, Paris

75235

NOT_YET_RECRUITING

University of Texas UT Southwestern Comprehensive Cancer Center, Dallas

77030

RECRUITING

MD Anderson Cancer Centre, Houston

80218

NOT_YET_RECRUITING

Presbyterian / St. Luke'S Medical Center, Denver

81675

RECRUITING

Tum Klinikum Rechts Der Isar, Munich

97401

NOT_YET_RECRUITING

Oncology Associates of Oregon, Eugene

1808610

RECRUITING

Japanese Red Cross Musashino Hospital, Musashino-city, Tokyo

2591193

RECRUITING

Tokai University Hospital, Isehara-city, Kanagawa

6708540

RECRUITING

Japanese Red Cross Society Himeji Hospital, Himeji-city, Hyogo

8128582

RECRUITING

Kyushu University Hospital, Higashi-ku, Fukuoka-city, Fukuoka

02114

NOT_YET_RECRUITING

Massachusetts General Hospital, Boston

062000

NOT_YET_RECRUITING

Chu de Nice - Hôpital L'Archet 1, Nice

01307

RECRUITING

Universitatsklinikum Dresden Carl Gustav Carus, Dresden

04103

RECRUITING

Universitaetsklinikum Leipzig, Leipzig

00133

NOT_YET_RECRUITING

"Dipartimento Di Biomedicina E Prevenzione - Universita Degli Studi Di Roma Tor Vergata", Roma

910-1193

RECRUITING

University of Fukui Hospital, Yoshida-gun

1081HV

NOT_YET_RECRUITING

Umc Amsterdam - Vumc, Amsterdam

9713GZ

NOT_YET_RECRUITING

Umc Groningen, Groningen

EH4 2XU

NOT_YET_RECRUITING

Western General Hospital, Edinburgh

LS9 7TF

NOT_YET_RECRUITING

St James' University Hospital, Leeds

NW1 2PG

RECRUITING

University College London Hospital, London

Unknown

RECRUITING

Kings College Hospital, London

OX3 7LE

RECRUITING

Churchill Hospital, Oxford

TQ2 7AA

NOT_YET_RECRUITING

Torbay Hospital, Torquay

All Listed Sponsors
collaborator

Servier Bio-Innovation LLC

INDUSTRY

lead

Institut de Recherches Internationales Servier

OTHER