93
Participants
Start Date
August 14, 2014
Primary Completion Date
June 15, 2026
Study Completion Date
June 15, 2027
Isavuconazole
Isavuconazole to begin at least 3 days prior to ibrutinib and continue throughout chemotherapy (cycles 1-6)
TEDDI
Temozolomide, etoposide, doxil, dexamthasone, ibrutinib (TEDDI) given every 21 days for cycles 2-6 (Arm 1-A); given every 21 days for cycles 1-6 (Arms 1-B, 2, 3 and 4)
Rituximab
Rituximab (R) given with TEDD and TEDDI every 3 weeks for cycles 1-6 (all arms)
Cytarabine
Cytarabine given via Ommaya reservoir (IT therapy) on days 1 and day 5 of cycles 2-6 (all arms)
TEDD
Temozolomide, etoposide, doxil, dexamthasone, (TEDD) given on first cycle (Arm 1-A)
Ibrutinib (Arms 2, 3 and 4)
Ibrutinib given on day -3 to day -1 on cycle 1 (Arms 2, 3 and 4)
Methotrexate
Methotrexate on days 1 and day 5 of cycles 2-6 (Arm 4)
Ibrutinib (Arm 1 - Closed with Amendment G)
Ibrutinib given on day -14 to day -1 on cycle 1 (Arm 1)
Ibrutinib (Arm 4)
Ibrutinib given on days 1-10 for cycles 1-6 (Arm 4)
RECRUITING
National Institutes of Health Clinical Center, Bethesda
National Cancer Institute (NCI)
NIH