SAKK 30/15; HOVON 135: A randomized phase II multicenter study to assess the to erability and efficacy of the addition of ibrutinib to 10-day decitabine in UNFIT (i.e. HCT-CI ≥ 3) AML and high risk myelodysplasia (MDS) (IPSS-R > 4.5) patients aged ≥ 66 years. A study in the frame of the masterprotocol of parallel randomized phase II studies in UNFITolder AML/high-risk MDS patients
Automatisch geschlossen · 2016 bis 2018
This is a prospective, open label, multicenter study that is conducted in the frame of a masterprotocol with multiple parallel randomized phase II arms. The scheme of this design consists of one arm with the standard treatment for AML (the 10-day decitabine schedule) as compared to various arms with experimental treatments. Patient popula-tion: Patients with AML (except FAB M3) or high risk MDS (IPSSR > 4.5), previously untreated, age ≥ 66 yrs AND Hematopoietic Cell Transplantation Co-morbidity Index (HCT-CI) ≥ 3. Intervention: Patients in this study are treated with 10-day decitabine treatment with or without ibrutinib. The starting dose of ibrutinib will be 560 mg once daily. During the part A run-in phase the dose level of ibrutinib will be established.