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Tolerability and Efficacy of Midostaurin to 10-day Decitabine in Unfit Adult AML and High Risk MDS Patients

Study acronym: HO155
StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Re-verified, no change to tracked fieldsv5
  2. Primary completion date changed from estimate of Jun 30, 2022 to Nov 15, 2021 Completion date: Mar 2026 to Nov 2026v4 Show 1 more changeShow less
    • Completion date: Mar 2026 to Nov 2026
  3. Primary completion date: Oct 2021 to Jun 30, 2022 Trial status: Recruiting to Active, Not Recruiting · Study sites: 24 to 37v3 Show 2 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Study sites: 24 to 37
  4. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Sep 16, 2019 to Dec 5, 2019 · Site details revised at 24 of 24 sitesv2 Show 2 more changesShow less
    • Start date changed from estimate of Sep 16, 2019 to Dec 5, 2019
    • Site details revised at 24 of 24 sites
  5. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The aim of this study is to investigate how safe and effective the addition of the new medicine midostaurin to decitabine is for the treatment of unfit acute myeloid leukemia (AML) and high-risk myelodysplasia (MDS) patients. Patients who are ineligible for intensive chemotherapy because of accompanying diseases may opt for gentler treatment. This does not produce a cure but serves to allow the quality of life to be acceptable for as long as possible. Decitabine is an example of a gentler treatment. It is effective against leukemia and has fewer side effects than intensive chemotherapy. Given in courses of 5 successive days, decitabine is registered for the treatment of AML. There is scientific research to suggest that decitabine is more effective and generally well tolerated when given in courses of 10 successive days. Therefore, treatment with 10-day courses of decitabine is the standard treatment in this scientific research. The aim is to investigate whether this standard treatment can be improved by adding a new product, midostaurin. Midostaurin is a medicine that is directed against a specific protein on leukaemia cells (FLT3).
Trial Details
NCT Number NCT04097470
Lead Sponsor Stichting Hemato-Oncologie voor Volwassenen Nederland
Collaborators: Swiss Cancer Institute
Conditions AML/MDS
Enrollment 140 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov