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)

Status: Recruiting
Location: See all (60) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Diagnosis of HMA naive IDH1 R132 mutated MDS defined according to WHO criteria (5th edition):

• Moderate high, high and very high-risk MDS per IPSS-M score will be eligible regardless of blood counts and with blast counts 0-19%.

• Low and moderate low-risk MDS per IPSS-M score must:

• Have cytopenias related to MDS, defined as: \<100 platelets/microliter, or absolute neutrophil count (ANC) \<1000/mm3, or hemoglobin \<10g/dL AND

• Have a blast count between 5-19% AND

• Be eligible for HMA therapy (very low risk participants are to be excluded)

• Locally or centrally confirmed IDH1 R132 C/G/H/L/S mutation

Locations
United States
Colorado
Presbyterian / St. Luke'S Medical Center
NOT_YET_RECRUITING
Denver
Illinois
University of Chicago, Duchossois Center for Advanced Medicine (DCAM)
RECRUITING
Chicago
Massachusetts
Massachusetts General Hospital
NOT_YET_RECRUITING
Boston
North Carolina
Unc Lineberger Comprehensive Cancer Center
RECRUITING
Chapel Hill
New York
MSKCC
NOT_YET_RECRUITING
New York
Ohio
Ohio State University Comprehensive Cancer Center
RECRUITING
Columbus
Oregon
Oncology Associates of Oregon
NOT_YET_RECRUITING
Eugene
Texas
University of Texas UT Southwestern Comprehensive Cancer Center
NOT_YET_RECRUITING
Dallas
MD Anderson Cancer Centre
RECRUITING
Houston
Other Locations
Australia
Monash Health
RECRUITING
Clayton
Northern Health
RECRUITING
Epping
Liverpool Hospital
NOT_YET_RECRUITING
Liverpool
Sir Charles Gairdner Hospital
RECRUITING
Nedlands
Calvary Mater Newcastle
RECRUITING
Waratah
Brazil
Liga Paranaense de Combate ao Câncer - Hospital Erasto Gaertner
NOT_YET_RECRUITING
Curitiba
Casa de Saúde Santa Marcelina
NOT_YET_RECRUITING
São Paulo
Centro de Pesquisa Clínica - Hospital Nove de Julho
NOT_YET_RECRUITING
São Paulo
Centro de Pesquisas Clínicas da Fundação Doutor Amaral Carvalho
NOT_YET_RECRUITING
São Paulo
Hospital das Clínicas da Faculdade de Medicina da USP
NOT_YET_RECRUITING
São Paulo
Instituto Nacional do Câncer
NOT_YET_RECRUITING
São Paulo
Real E Benemérita Associação Portuguesa de São Paulo
NOT_YET_RECRUITING
São Paulo
Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein
RECRUITING
São Paulo
France
Chu Nantes-Hotel Dieu
NOT_YET_RECRUITING
Nantes
Chu de Nice - Hôpital L'Archet 1
RECRUITING
Nice
Hopital Saint Louis
NOT_YET_RECRUITING
Paris
Chu Bordeaux, Hopital Du Haut Leveque
NOT_YET_RECRUITING
Pessac
Institut Universitaire Du Cancer Toulouse-Oncopole
RECRUITING
Toulouse
Chu Brabois
NOT_YET_RECRUITING
Vandœuvre-lès-nancy
Germany
Universitatsklinikum Dresden Carl Gustav Carus
RECRUITING
Dresden
Marien Hospital Duesseldorf
NOT_YET_RECRUITING
Düsseldorf
Universitaetsmedizin Goettingen (Umg)
NOT_YET_RECRUITING
Göttingen
Universitaetsklinikum Leipzig
RECRUITING
Leipzig
Tum Klinikum Rechts Der Isar
RECRUITING
Munich
Italy
Azienda Ospedaliero Universitaria Delle Marche
RECRUITING
Ancona
Istituto Di Ematologia Lorenzo E Ariosto Seragnoli - Policlinico Di S. Orsola
NOT_YET_RECRUITING
Bologna
Azienda Ospedaliero-Universitaria Careggi
RECRUITING
Florence
Humanitas Research Hospital (Istituto Clinico Humanitas)
NOT_YET_RECRUITING
Milan
Fondazione I.R.C.C.S. Policlinico San Matteo
NOT_YET_RECRUITING
Pavia
Dipartimento Di Biomedicina E Prevenzione - Universita Degli Studi Di Roma Tor Vergata
NOT_YET_RECRUITING
Roma
Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino - Presidio Molinette
NOT_YET_RECRUITING
Torino
Japan
Kyushu University Hospital
RECRUITING
Higashi-ku, Fukuoka-city, Fukuoka
Japanese Red Cross Society Himeji Hospital
RECRUITING
Himeji-city, Hyogo
Tokai University Hospital
RECRUITING
Isehara-city, Kanagawa
Japanese Red Cross Musashino Hospital
RECRUITING
Musashino-city, Tokyo
University of Fukui Hospital
RECRUITING
Yoshida-gun
Netherlands
Umc Amsterdam - Vumc
RECRUITING
Amsterdam
Umc Groningen
NOT_YET_RECRUITING
Groningen
Spain
Institut Catala D' Oncologia
NOT_YET_RECRUITING
Badalona
H. Valle de Hebron
NOT_YET_RECRUITING
Barcelona
Clinica Universitaria de Navarra (Madrid)
RECRUITING
Madrid
Clinica Universitaria de Navarra (Pamplona)
RECRUITING
Pamplona
Hospital Clinico Universitario de Salamanca
RECRUITING
Salamanca
Hospital Universitario Virgen de La Macarena
RECRUITING
Seville
H. Universitario La Fe
RECRUITING
Valencia
United Kingdom
Western General Hospital
NOT_YET_RECRUITING
Edinburgh
St James' University Hospital
NOT_YET_RECRUITING
Leeds
Kings College Hospital
RECRUITING
London
University College London Hospital
RECRUITING
London
Churchill Hospital
RECRUITING
Oxford
Torbay Hospital
NOT_YET_RECRUITING
Torquay
Contact Information
Primary
Institut de Recherches Internationales Servier (I.R.I.S.), Clinical Studies Department
scientificinformation@servier.com
+33 1 55 72 60 00
Time Frame
Start Date: 2024-12-03
Estimated Completion Date: 2028-12-01
Participants
Target number of participants: 48
Treatments
Experimental: Ivosidenib monotherapy
Experimental: Azacitidine monotherapy
Related Therapeutic Areas
Sponsors
Collaborators: Servier Bio-Innovation LLC
Leads: Institut de Recherches Internationales Servier

This content was sourced from clinicaltrials.gov

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