Temozolomide, Etoposide, Doxil, Dexamethasone, Ibrutinib, and Rituximab (TEDDI-R) in Aggressive B-cell Lymphomas With Secondary Involvement of the Central Nervous System (CNS)

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

48

Participants

Timeline

Start Date

June 27, 2019

Primary Completion Date

July 1, 2027

Study Completion Date

July 1, 2028

Conditions
Central Nervous System LymphomaSecondary Central Nervous System Lymphoma
Interventions
DRUG

TEDD-R

Temozolomide, etoposide, doxil, dexamthasone, and rituximab (TEDD-R) given every 21 days for cycles 1-4

DRUG

TEDDI-R

Temozolomide, etoposide, doxil, dexamthasone, ibrutinib and rituximab (TEDDI-R) given every 21 days for cycles 1-4

DRUG

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

DRUG

Cytarabine

Cytarabine on days 1 and day 5 of cycles 2-5 (all arms), as applicable

DRUG

Isavuconazole

Isavuconazole to begin at least 3 days prior to ibrutinib and continue throughout chemotherapy unless ibrutinib discontinued permanently

DRUG

Methotrexate

Methotrexate on days 1 and day 5 of cycles 2-5 (all arms), as applicable

Trial Locations (1)

20892

National Institutes of Health Clinical Center, Bethesda

All Listed Sponsors
lead

National Cancer Institute (NCI)

NIH