New hope for rare MDS: targeted drug ivosidenib takes on standard therapy

NCT ID NCT06465953

Recruiting now Disease control Sponsor: Institut de Recherches Internationales Servier Source: ClinicalTrials.gov ↗

First seen Jun 25, 2026 · Last updated Aug 06, 2026 · Updated 3 times

Summary

This study is for people with a rare form of myelodysplastic syndromes (MDS) that has a specific genetic change called IDH1 mutation. Participants have not had prior treatment with certain drugs. They will be randomly assigned to receive either ivosidenib (a daily pill) or azacitidine (injections for 7 days each month). The goal is to see which drug helps control the disease better, looking at remission rates and overall survival.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: Ivosidenib (a targeted drug) and azacitidine (a chemotherapy-like drug)
What this could lead to: If it works, this could point toward a more effective treatment for a specific type of MDS, potentially improving remission rates.
What could go wrong: This is a small, early-phase 3 trial with only 48 participants. The drug may not work better than the standard treatment, and side effects are possible.

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Conditions

The condition(s) this trial relates to.

myelodysplastic syndrome Myelodysplastic Syndromes

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

HYPOMETHYLATING AGENT (HMA) NAIVE MYELODYSPLASTIC SYNDROMES (MDS) MYELODYSPLASTIC SYNDROMES (MDS)

Contacts and locations

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Study contacts

Contact

Email: •••••@•••••

Locations

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

Torino, 10126, Italy
Azienda Ospedaliero Universitaria Delle Marche
RECRUITING

Ancona, 60126, Italy
Azienda Ospedaliero-Universitaria Careggi
RECRUITING

Florence, 50139, Italy
Calvary Mater Newcastle
RECRUITING

Waratah, 2298, Australia
Casa de Saúde Santa Marcelina
NOT_YET_RECRUITING

São Paulo, 08270-120, Brazil
Centro de Pesquisa Clínica - Hospital Nove de Julho
RECRUITING

São Paulo, 01308-070, Brazil
Centro de Pesquisas Clínicas da Fundação Doutor Amaral Carvalho
NOT_YET_RECRUITING

São Paulo, 17210-190, Brazil
Chu Bordeaux, Hopital Du Haut Leveque
RECRUITING

Pessac, 33600, France
Chu Brabois
RECRUITING

Vandœuvre-lès-Nancy, 54500, France
Chu Nantes-Hotel Dieu
RECRUITING

Nantes, 44093, France
Chu de Nice - Hôpital L'Archet 1
RECRUITING

Nice, 062000, France
Churchill Hospital
RECRUITING

Oxford, OX3 7LE, United Kingdom
Clinica Universitaria de Navarra (Madrid)
RECRUITING

Madrid, 28027, Spain
Clinica Universitaria de Navarra (Pamplona)
RECRUITING

Pamplona, 31008, Spain
Dipartimento Di Biomedicina E Prevenzione - Universita Degli Studi Di Roma "Tor Vergata"
RECRUITING

Roma, 00133, Italy
Fondazione I.R.C.C.S. Policlinico San Matteo
RECRUITING

Pavia, 27100, Italy
H. Universitario La Fe
RECRUITING

Valencia, 46026, Spain
H. Valle de Hebron
RECRUITING

Barcelona, 8035, Spain
Hopital Saint Louis
RECRUITING

Paris, 75010, France
Hospital Clinico Universitario de Salamanca
RECRUITING

Salamanca, 37007, Spain
Hospital Universitario Virgen de La Macarena
RECRUITING

Seville, 41009, Spain
Hospital das Clínicas da Faculdade de Medicina da USP
RECRUITING

São Paulo, 05403-010, Brazil
Humanitas Research Hospital (Istituto Clinico Humanitas)
RECRUITING

Milan, 20089, Italy
Institut Catala D' Oncologia
RECRUITING

Badalona, 8916, Spain
Institut Universitaire Du Cancer Toulouse-Oncopole
RECRUITING

Toulouse, 31059, France
Instituto Nacional do Câncer
NOT_YET_RECRUITING

São Paulo, 20231-050, Brazil
Istituto Di Ematologia "Lorenzo E Ariosto Seragnoli" - Policlinico Di S. Orsola
RECRUITING

Bologna, 40138, Italy
Japanese Red Cross Musashino Hospital
RECRUITING

Musashino-city, Tokyo, 1808610, Japan
Japanese Red Cross Society Himeji Hospital
RECRUITING

Himeji-city, Hyogo, 6708540, Japan
Kings College Hospital
RECRUITING

London, United Kingdom
Kitasato University Hospital
NOT_YET_RECRUITING

Sagamihara, 252-0375, Japan
Kyushu University Hospital
RECRUITING

Higashi-ku, Fukuoka-city, Fukuoka, 8128582, Japan
Liga Paranaense de Combate ao Câncer - Hospital Erasto Gaertner
RECRUITING

Curitiba, 81520-060, Brazil
Liverpool Hospital
NOT_YET_RECRUITING

Liverpool, 2170, Australia
MD Anderson Cancer Centre
RECRUITING

Houston, Texas, 77030, United States
MSKCC
RECRUITING

New York, New York, 10065, United States
Marien Hospital Duesseldorf
RECRUITING

Düsseldorf, 40477, Germany
Massachusetts General Hospital
RECRUITING

Boston, Massachusetts, 02114, United States
Monash Health
RECRUITING

Clayton, 3168, Australia
Northern Health
RECRUITING

Epping, 3076, Australia
Ohio State University Comprehensive Cancer Center
RECRUITING

Columbus, Ohio, 43210, United States
Oncology Associates of Oregon
RECRUITING

Eugene, Oregon, 97401, United States
Presbyterian / St. Luke'S Medical Center
NOT_YET_RECRUITING

Denver, Colorado, 80218, United States
Real E Benemérita Associação Portuguesa de São Paulo
RECRUITING

São Paulo, 01321-001, Brazil
Royal Adelaide Hospital
NOT_YET_RECRUITING

Adelaide, 5000, Australia
Sir Charles Gairdner Hospital
RECRUITING

Nedlands, 6009, Australia
Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein
RECRUITING

São Paulo, 05652-900, Brazil
St James' University Hospital
WITHDRAWN

Leeds, LS9 7TF, United Kingdom
Tokai University Hospital
RECRUITING

Isehara-city, Kanagawa, 2591193, Japan
Torbay Hospital
RECRUITING

Torquay, TQ2 7AA, United Kingdom
Tum Klinikum Rechts Der Isar
RECRUITING

Munich, 81675, Germany
Umc Amsterdam - Vumc
RECRUITING

Amsterdam, 1081HV, Netherlands
Umc Groningen
RECRUITING

Groningen, 9713GZ, Netherlands
Unc Lineberger Comprehensive Cancer Center
RECRUITING

Chapel Hill, North Carolina, 27514, United States
Universitaetsklinikum Leipzig
RECRUITING

Leipzig, 04103, Germany
Universitaetsmedizin Goettingen (Umg)
RECRUITING

Göttingen, 37075, Germany
Universitatsklinikum Dresden Carl Gustav Carus
RECRUITING

Dresden, 01307, Germany
University College London Hospital
RECRUITING

London, NW1 2PG, United Kingdom
University of Chicago, Duchossois Center for Advanced Medicine (DCAM)
RECRUITING

Chicago, Illinois, 60637, United States
University of Fukui Hospital
RECRUITING

Yoshida-gun, Eiheiji-cho 670-8540 Himeji, 910-1193, Japan
University of Texas UT Southwestern Comprehensive Cancer Center
NOT_YET_RECRUITING

Dallas, Texas, 75235, United States
Western General Hospital
RECRUITING

Edinburgh, EH4 2XU, United Kingdom

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