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

PHASE1CompletedINTERVENTIONAL
Enrollment

16

Participants

Timeline

Start Date

July 17, 2018

Primary Completion Date

July 15, 2019

Study Completion Date

October 15, 2019

Conditions
Acute Myeloid Leukemia
Interventions
DRUG

Selinexor

"According to escalation level:~* Level -1: Selinexor 40 mg/day, once weekly~* Level 1: Selinexor 60 mg/day, once weekly~* Level 2: Selinexor 80 mg/day, once weekly~* Level 3: Selinexor 100 mg/day, once weekly"

DRUG

fludarabine

fludarabine 30 mg/m2/day intravenously on days 1 to 4

DRUG

idarubicin

idarubicin 10 mg/m2/day intravenously on days 1 to 3

DRUG

cytarabine

cytarabine 2 g/m2/day intravenously on days 1 to 4

DRUG

G-CSF

G-CSF 300 mcg/m2/day subcutaneously from days -1 to 5

Trial Locations (4)

Unknown

Hospital Germans Tries i Pujol, Badalona, Badalona

Hospital San Pedro de Alcántara,, Cáceres

Hospital Universitario 12 de Octubre,, Madrid

Hospital la Fe, Valencia

All Listed Sponsors
lead

PETHEMA Foundation

OTHER

NCT03661515 - Selinexor (KPT-330) Plus FLAG-Ida for the Treatment of Relapsing/Refractory AML | Biotech Hunter | Biotech Hunter