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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

RecruitingPhase 3Ages 18 Years - anyAllInstitut de Recherches Internationales Servier
NCT06465953 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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 Exclusion Criteria: * 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
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What it tests

  • Ivosidenib
  • Azacitidine
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Where

62 sites
Presbyterian / St. Luke'S Medical Center
Denver, United States
University of Chicago, Duchossois Center for Advanced Medicine (DCAM)
Chicago, United States
Massachusetts General Hospital
Boston, United States
MSKCC
New York, United States
Unc Lineberger Comprehensive Cancer Center
Chapel Hill, United States
Ohio State University Comprehensive Cancer Center
Columbus, United States
Oncology Associates of Oregon
Eugene, United States
University of Texas UT Southwestern Comprehensive Cancer Center
Dallas, United States

…and 54 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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