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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

Study acronym: PyramIDH
StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Site details revised at 4 of 62 sitesv11
  2. Site details revised at 1 of 62 sitesv10
  3. Site contacts updated at 1 of 62 sitesv9
  4. Site details revised at 16 of 62 sitesv8
  5. Study sites: 60 to 62v7
Show 5 earlier versionsHide 5 earlier versions
  1. Study sites: 52 to 60v6
  2. Primary endpoint revised Secondary endpoints revised (18)v5 Show 1 more changeShow less
    • Secondary endpoints revised (18)

    See this version in full on ClinicalTrials.gov ↗

  3. Study sites: 21 to 52v4
  4. Study sites: 1 to 21v3
  5. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 1 · Start date changed from estimate of Dec 30, 2024 to Dec 3, 2024v2 Show 2 more changesShow less
    • Study sites: 0 to 1
    • Start date changed from estimate of Dec 30, 2024 to Dec 3, 2024
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06465953
Lead Sponsor Institut de Recherches Internationales Servier
Collaborators: Servier Bio-Innovation LLC
Conditions Hypomethylating Agent (HMA) Naive Myelodysplastic Syndromes (MDS), Myelodysplastic Syndromes (MDS)
Enrollment 48 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov