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

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).

Timeline

Start

2018-07-17

Primary completion

2019-07-15

Completion

2019-10-15

Publications

• Martinez Sanchez MP, Megias-Vericat JE, Rodriguez-Veiga R, Vives S, Bergua JM, Torrent A, Suarez-Varela S, Boluda B, Martinez-Lopez J, Cano-Ferri I, Acuna-Cruz E, Torres-Minana L, Martin-Herreros B, Serrano A, Sempere A, Barragan E, Sargas C, Sanz M, Martinez-Cuadron D, Montesinos P; PETHEMA group. A phase I trial of selinexor plus FLAG-Ida for the treatment of refractory/relapsed adult acute myeloid leukemia patients. Ann Hematol. 2021 Jun;100(6):1497-1508. doi: 10.1007/s00277-021-04542-8. Epub 2021 Apr 29.

Drugs

Indications