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A Study of Ivosidenib or Enasidenib in Combination With Induction Therapy and Consolidation Therapy, Followed by Maintenance Therapy in Patients With Newly Diagnosed Acute Myeloid Leukemia or Myedysplastic Syndrome EB2, With an IDH1 or IDH2 Mutation, Respectively, Eligible for Intensive Chemotherapy

Study acronym: HOVON150AML
StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Eligibility criteria expanded, about 47 words Secondary endpoints: details revised at 9 of 11 entries · Collaborator revised Show 2 more changesShow less
    • Secondary endpoints: details revised at 9 of 11 entries
    • Collaborator revised
  2. Completion date: Sep 17, 2034 to Sep 19, 2034v6
  3. Primary completion date: Oct 2024 to Apr 17, 2027 Trial status: Recruiting to Active, Not Recruiting · Study sites: 182 to 181 · Completion date: May 2034 to Sep 17, 2034v5 Show 3 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Study sites: 182 to 181
    • Completion date: May 2034 to Sep 17, 2034
  4. Primary completion date: Mar 2023 to Oct 2024 Completion date: Mar 2033 to May 2034v4 Show 1 more changeShow less
    • Completion date: Mar 2033 to May 2034
  5. Study sites: 1 to 182 Eligibility criteria expanded, about 228 wordsv3 Show 1 more changeShow less
    • Eligibility criteria expanded, about 228 words

    See this version in full on ClinicalTrials.gov ↗

  6. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 1 · Primary completion date: Feb 2023 to Mar 2023 · Completion date: Feb 2033 to Mar 2033 · 1 morev2 Show 4 more changesShow less
    • Study sites: 0 to 1
    • Primary completion date: Feb 2023 to Mar 2023
    • Completion date: Feb 2033 to Mar 2033
    • Start date changed from estimate of Feb 2019 to Mar 1, 2019
  7. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
AML and MDS-EB2 are malignancies of the bone marrow. The standard treatment for these diseases is chemotherapy. Patients participating have a special type of this disease because the leukemia cells (blasts) have developed an error in the genetic material (DNA). This error is called an IDH1 mutation or an IDH2 mutation (a mutation is a change in the DNA), which leads to changes in specific substances in the leukemia cells. This trial will investigate whether the addition of the new drugs Ivosidenib (for patients with IDH1 mutation) or Enasidenib (for patients with IDH2 mutation) to the standard treatment of chemotherapy controle the disease more effectively and for a longer period.
Trial Details
NCT Number NCT03839771
Lead Sponsor Stichting Hemato-Oncologie voor Volwassenen Nederland
Collaborators: University of Ulm
Conditions Acute Myeloid Leukemia, Myelodysplastic Syndrome With Excess Blasts-2
Enrollment 968 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov