Selinexor in Combination With Fludarabine and Cytarabine in Patients With Refractory or Relapsed Acute Myeloid Leukemia

PHASE2TerminatedINTERVENTIONAL
Enrollment

37

Participants

Timeline

Start Date

January 14, 2016

Primary Completion Date

April 30, 2019

Study Completion Date

April 30, 2019

Conditions
Acute Myeloid Leukemia (AML)
Interventions
DRUG

Selinexor

Given orally on days 1,3,8,10,22 and 24 of each cycle

DRUG

Fludarabine

Will be given intravenously (IV) over 30 minutes daily on days 16 through 20. Fludarabine may be given prior to day 16 if it is determined to be in the participant's best interest based on disease progression. Chemotherapy may be delayed by 1-3 days if clinically indicated.

DRUG

Cytarabine

Will be given IV over 4 hours daily on days 16 through 20. Cytarabine may be given prior to day 16 if it is determined to be in the participant's best interest based on disease progression. Chemotherapy may be delayed by 1-3 days if clinically indicated.

DRUG

methotrexate/hydrocortisone/cytarabine

Intrathecal (IT) triples will be given prior to cycle 1: IT cytarabine, IT methotrexate, and IT methotrexate/hydrocortisone/cytarabine (MHA) are acceptable. Patients without evidence of central nervous system (CNS) leukemia will receive no further IT therapy during cycle 1. Patients with CNS disease will receive weekly ITMHA until the cerebrospinal fluid becomes free of leukemia (minimum of 4 doses).

Trial Locations (7)

27710

Duke University Medical Center, Durham

38105

St. Jude Children's Research Hospital, Memphis

48201

Children's Hospital of Michigan, Detroit

60637

University of Chicago, Chicago

76104

Cook Children's Medical Center, Fort Worth

85016

Phoenix Children's Hospital, Phoenix

94304

Lucile Packard Children's Hospital Stanford University, Palo Alto

Sponsors
All Listed Sponsors
collaborator

Karyopharm Therapeutics Inc

INDUSTRY

lead

St. Jude Children's Research Hospital

OTHER