HOVON 155

A randomized phase II multicenter study to assess the tolerability and efficacy of the addition of midostaurin to 10-day decitabine in unfit (i.e. HCT-CI ≥ 3) adult AML and high risk myelodysplasia (MDS) (IPSS-R > 4.5) patients. 

Study treatments

10-day decitabine treatment with or without addition of midostaurin

Inclusion criteria

• Patients with:
  • a diagnosis of AML and related precursor neoplasms according to WHO 2016 classification (excluding acute promyelocytic leukemia) including secondary AML (after an antecedent hematological disease (e.g. MDS) and therapy-related AML, 
  • a diagnosis of myelodysplastic syndrome with excess of blasts (MDS) and IPSS-R > 4,5.
• Patients 18 years and older.
• Patients NOT eligible for standard chemotherapy, defined as HCT-CI ≥ 3. (Appendix G)
  OR
  Patients NOT eligible for standard chemotherapy for other reasons (wish of patient).

Exclusion criteria

•  Acute promyelocytic leukemia.
• Acute leukemia's of ambiguous lineage according to WHO 2016
• Patient has symptomatic central nervous system (CNS) leukemia (NO routinely lumbar puncture required to investigate CNS involvement)
• Blast crisis of chronic myeloid leukemia

Participating sites

• AZ Delta Roeselare
• ZNA Antwerpen