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Ivosidenib (IVO) Monotherapy and Azacitidine (AZA) Monotherapy in Patients With Hypomethylating Agent (HMA) Naive Myelodysplastic Syndromes (MDS) With an IDH1 Mutation
Sponsor: Institut de Recherches Internationales Servier
Summary
This study will enroll participants with myelodysplastic syndromes (MDS) with an Isocitrate dehydrogenase protein, 1 (IDH1) mutation, who have not received treatment with a hypomethylating agent previously. Participants will be randomized to receive either ivosidenib (IVO) alone or azacitidine (AZA) alone. IVO will be administered daily throughout the 28-day treatment cycle and AZA will be administered for the first 7 days of each 28-day cycle. Study visits will be conducted every week during Cycle 1 (Days 1, 8, 15, and 22), and Day 1 of each cycle thereafter. After the last dose of treatment, participants will attend an safety follow-up visit and participants will be followed to assess overall survival. Study visits may include a bone marrow aspirate, physical exam, echocardiogram (ECHO), electrocardiogram (ECG), blood and urine analysis, and questionnaires.
Official title: A Phase 3, Multicenter, Open Label, Randomized, Non-comparative Two-arm Study of Ivosidenib (IVO) Monotherapy and Azacitidine (AZA) Monotherapy in Adult Patients With Hypomethylating Agent (HMA) Naive Myelodysplastic Syndromes (MDS) With an Isocitrate Dehydrogenase-1 (IDH1) Mutation (PyramIDH Study)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
48
Start Date
2024-12-03
Completion Date
2028-12-01
Last Updated
2026-04-03
Healthy Volunteers
No
Conditions
Interventions
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.
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.
Locations (62)
Presbyterian / St. Luke'S Medical Center
Denver, Colorado, United States
University of Chicago, Duchossois Center for Advanced Medicine (DCAM)
Chicago, Illinois, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
MSKCC
New York, New York, United States
Unc Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, United States
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States
Oncology Associates of Oregon
Eugene, Oregon, United States
University of Texas UT Southwestern Comprehensive Cancer Center
Dallas, Texas, United States
MD Anderson Cancer Centre
Houston, Texas, United States
Royal Adelaide Hospital
Adelaide, Australia
Monash Health
Clayton, Australia
Northern Health
Epping, Australia
Liverpool Hospital
Liverpool, Australia
Sir Charles Gairdner Hospital
Nedlands, Australia
Calvary Mater Newcastle
Waratah, Australia
Liga Paranaense de Combate ao Câncer - Hospital Erasto Gaertner
Curitiba, Brazil
Centro de Pesquisa Clínica - Hospital Nove de Julho
São Paulo, Brazil
Real E Benemérita Associação Portuguesa de São Paulo
São Paulo, Brazil
Hospital das Clínicas da Faculdade de Medicina da USP
São Paulo, Brazil
Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein
São Paulo, Brazil
Casa de Saúde Santa Marcelina
São Paulo, Brazil
Centro de Pesquisas Clínicas da Fundação Doutor Amaral Carvalho
São Paulo, Brazil
Instituto Nacional do Câncer
São Paulo, Brazil
Chu Nantes-Hotel Dieu
Nantes, France
Chu de Nice - Hôpital L'Archet 1
Nice, France
Hopital Saint Louis
Paris, France
Chu Bordeaux, Hopital Du Haut Leveque
Pessac, France
Institut Universitaire Du Cancer Toulouse-Oncopole
Toulouse, France
Chu Brabois
Vandœuvre-lès-Nancy, France
Universitatsklinikum Dresden Carl Gustav Carus
Dresden, Germany
Marien Hospital Duesseldorf
Düsseldorf, Germany
Universitaetsmedizin Goettingen (Umg)
Göttingen, Germany
Universitaetsklinikum Leipzig
Leipzig, Germany
Tum Klinikum Rechts Der Isar
Munich, Germany
Azienda Ospedaliero Universitaria Delle Marche
Ancona, Italy
Istituto Di Ematologia "Lorenzo E Ariosto Seragnoli" - Policlinico Di S. Orsola
Bologna, Italy
Azienda Ospedaliero-Universitaria Careggi
Florence, Italy
Humanitas Research Hospital (Istituto Clinico Humanitas)
Milan, Italy
Fondazione I.R.C.C.S. Policlinico San Matteo
Pavia, Italy
Dipartimento Di Biomedicina E Prevenzione - Universita Degli Studi Di Roma "Tor Vergata"
Roma, Italy
Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino - Presidio Molinette
Torino, Italy
University of Fukui Hospital
Yoshida-gun, Eiheiji-cho 670-8540 Himeji, Japan
Kyushu University Hospital
Higashi-ku, Fukuoka-city, Fukuoka, Japan
Japanese Red Cross Society Himeji Hospital
Himeji-city, Hyogo, Japan
Tokai University Hospital
Isehara-city, Kanagawa, Japan
Japanese Red Cross Musashino Hospital
Musashino-city, Tokyo, Japan
Kitasato University Hospital
Sagamihara, Japan
Umc Amsterdam - Vumc
Amsterdam, Netherlands
Umc Groningen
Groningen, Netherlands
Institut Catala D' Oncologia
Badalona, Spain
H. Valle de Hebron
Barcelona, Spain
Clinica Universitaria de Navarra (Madrid)
Madrid, Spain
Clinica Universitaria de Navarra (Pamplona)
Pamplona, Spain
Hospital Clinico Universitario de Salamanca
Salamanca, Spain
Hospital Universitario Virgen de La Macarena
Seville, Spain
H. Universitario La Fe
Valencia, Spain
Western General Hospital
Edinburgh, United Kingdom
St James' University Hospital
Leeds, United Kingdom
University College London Hospital
London, United Kingdom
Kings College Hospital
London, United Kingdom
Churchill Hospital
Oxford, United Kingdom
Torbay Hospital
Torquay, United Kingdom