A randomized phase II multicenter study to assess the tolerability 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 UNFIT-older AML/high-risk MDS patients.

Trial Profile

A randomized phase II multicenter study to assess the tolerability 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 UNFIT-older AML/high-risk MDS patients.

Recruiting
Phase of Trial: Phase II

Latest Information Update: 06 Aug 2017

At a glance

  • Drugs Ibrutinib (Primary) ; Decitabine
  • Indications Myelodysplastic syndromes; Myeloid leukaemia
  • Focus Therapeutic Use
  • Acronyms HOVON 135 AML /SAKK 30/15
  • Most Recent Events

    • 12 Apr 2016 New trial record
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