48
Participants
Start Date
June 27, 2019
Primary Completion Date
July 1, 2027
Study Completion Date
July 1, 2028
TEDD-R
Temozolomide, etoposide, doxil, dexamthasone, and rituximab (TEDD-R) given every 21 days for cycles 1-4
TEDDI-R
Temozolomide, etoposide, doxil, dexamthasone, ibrutinib and rituximab (TEDDI-R) given every 21 days for cycles 1-4
Ibrutinib
For Arm 1:Ibrutinib given on days -14 to day -1 prior to cycle 1;then given every 21 days for cycles 1-4 For Arm 2: Ibrutinib given on days -14 to day -1 prior to cycle 1; then on days 1-10 for cycles 1-4
Cytarabine
Cytarabine on days 1 and day 5 of cycles 2-5 (all arms), as applicable
Isavuconazole
Isavuconazole to begin at least 3 days prior to ibrutinib and continue throughout chemotherapy unless ibrutinib discontinued permanently
Methotrexate
Methotrexate on days 1 and day 5 of cycles 2-5 (all arms), as applicable
National Institutes of Health Clinical Center, Bethesda
National Cancer Institute (NCI)
NIH