A Phase II Study of Selinexor Plus Cytarabine and Idarubicin in Patients With Relapsed/Refractory Acute Myeloid Leukemia (AML)

PHASE2CompletedINTERVENTIONAL
Enrollment

42

Participants

Timeline

Start Date

September 30, 2014

Primary Completion Date

July 31, 2018

Study Completion Date

July 31, 2018

Conditions
Acute Myeloid Leukemia (Relapsed/Refractory)
Interventions
DRUG

Selinexor

Patients receive Selinexor as specified in arm/group description (8 doses of 40 mg/m\^2 or 6 doses of 60 mg per induction cycle).

DRUG

Idarubicin

Infusion, iv, 10 mg/m\^2, on days 1,3,5 in cycle 1, on days 1,3 in cycle 2

DRUG

Cytarabine

Continuous infusion day 1 to 7, 100 mg/m\^2, iv,

Trial Locations (3)

20246

Universitätsklinikum Hamburg-Eppendorf, Hamburg

30625

Medizinische Hochschule Hannover, Hanover

60590

Universitätsklinikum Frankfurt, Frankfurt am Main

All Listed Sponsors
collaborator

Karyopharm Therapeutics Inc

INDUSTRY

lead

GSO Global Clinical Research BV

OTHER