37
Participants
Start Date
January 14, 2016
Primary Completion Date
April 30, 2019
Study Completion Date
April 30, 2019
Selinexor
Given orally on days 1,3,8,10,22 and 24 of each cycle
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.
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.
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).
Duke University Medical Center, Durham
St. Jude Children's Research Hospital, Memphis
Children's Hospital of Michigan, Detroit
University of Chicago, Chicago
Cook Children's Medical Center, Fort Worth
Phoenix Children's Hospital, Phoenix
Lucile Packard Children's Hospital Stanford University, Palo Alto
Collaborators (1)
Karyopharm Therapeutics Inc
INDUSTRY
St. Jude Children's Research Hospital
OTHER