Overview

Selinexor (KPT-330) Plus FLAG-Ida for the Treatment of Relapsing/Refractory AML

Status:
Completed
Trial end date:
2019-10-15
Target enrollment:
Participant gender:
Summary
This protocol corresponds to a multicenter, open-label, non-randomized, phase I study designed to determine the safety of the combination of selinexor with chemotherapy in young patients with relapsed or refractory AML. The clinical trial is divided into pre-treatment, treatment (induction and consolidation cycles) and follow-up periods and consists of a phase I design in which es-calating doses of selinexor will be given to 3 groups, each with 3-6 patients until achieving the maximum tolerated dose (MTD).
Phase:
Phase 1
Details
Lead Sponsor:
PETHEMA Foundation
Treatments:
Cytarabine
Fludarabine
Fludarabine phosphate
Idarubicin
Vidarabine