NCT02403310 - A Study of Selinexor in Combination With Daunorubicin and Cytarabine for Untreated AML | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

June 18, 2015

Primary Completion Date

September 13, 2016

Study Completion Date

February 1, 2021

Conditions

LeukemiaAcute Myeloid LeukemiaAML

Interventions

DRUG

Selinexor

"Induction: Oral selinexor on days 1, 3, 8, 10, 15 and 17.~* Dose Level 2: 80 mg twice weekly.~* Dose Level 1 (starting dose): 60 mg twice weekly.~* Dose Level -1: 40 mg twice weekly.~Consolidation: Selinexor same dose as induction (days 1,3,8,10) unless dose limiting toxicity (DLT) dictates a dose reduction.~Maintenance: Selinexor at the same dose as induction on days 1 and 8 a 21 day cycle. They will continue for a maximum of 12 months."

DRUG

Daunorubicin

"Induction: Daunorubicin 60 mg/m\^2/day (days 1-3).~Consolidation: Daunorubicin 45 mg/m\^2/day (days 1-2)."

DRUG

Cytarabine

"Induction: Cytarabine 100 mg/m\^2/day (days 1-7).~Consolidation: Cytarabine 100 mg/m\^2/day (continuous infusion on days 1-5)."

Trial Locations (1)

33612

H. Lee Moffitt Cancer Center and Research Institute, Tampa