Tolerability and Efficacy of Midostaurin to 10-day Decitabine in Unfit Adult AML and High Risk MDS Patients
Status:
Recruiting
Trial end date:
2026-03-01
Target enrollment:
Participant gender:
Summary
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).
Phase:
Phase 2
Details
Lead Sponsor:
Stichting Hemato-Oncologie voor Volwassenen Nederland