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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

48 patients around the world

Available in United States, Brazil

Institut de Recherches Internationales Servier

8Research sites

48Patients around the world

This study is for people with

Myelodysplastic Syndromes

From 18 Years

All Gender

: 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.
Have a blast count between 5-19%.
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.

: Received prior anticancer/disease modifying treatment for MDS (including HMA's, cytotoxic chemotherapy, investigational agents, bcl-2 inhibitor based-regimens, hematopoietic stem cell transplant (HSCT), IDH1 inhibitors). For LR-MDS patients, prior treatment with growth factors, luspatercept, lenalidomide, and imetelstat are allowed.
>20% blasts by morphology or immunohistochemistry on screening bone marrow aspirate/biopsy.

Hospital Erasto Gaertner

R. Dr. Ovande do Amaral, 201 - Jardim das Américas, Curitiba - PR, 81520-060, Brazil

Hospital Nove de Julho

Rua Peixoto Gomide, 545 - Jardim Paulista, São Paulo - SP, 01409-001, Brazil

Beneficência Portuguesa de São Paulo

R. Maestro Cardim, 637 - Bela Vista, São Paulo - SP, 01323-001

Hospital das Clínicas da Faculdade de Medicina da São Paulo - USP

Rua Dr. Ovídio Pires de Campos 785 - Estado de São Paulo 05403-000

Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein

Recruiting

Bloco A1 - Av. Albert Einstein, 627 - Jardim Leonor, São Paulo - SP, 05652-900, Brazil

Hospital Santa Marcelina

R. Santa Marcelina, 177 - Vila Carmosina, São Paulo - SP, 08270-070

Centro de Pesquisas Clinicas da Fundacao Doutor Amaral Carvalho

Jau, 17210080

Instituto do Câncer do Estado de São Paulo "Octavio Frias de Oliveira" - ICESP

Av. Dr. Arnaldo, 251 - Consolação, São Paulo - SP, 01255-090, Brazil

StudyPyramIDH

SponsorInstitut de Recherches Internationales Servier

Study typeInterventional

Conditions

Myelodysplastic Syndromes

Requirements

From 18 YearsAll Gender

Unique study IDclinicaltrials.gov

NCT06465953