Phase 1 Study of Ibrutinib and Immuno-Chemotherapy Using Temozolomide, Etoposide, Doxil, Dexamethasone, Ibrutinib,Rituximab (TEDDI-R) in Primary CNS Lymphoma

PHASE1RecruitingINTERVENTIONAL
Enrollment

93

Participants

Timeline

Start Date

August 14, 2014

Primary Completion Date

June 15, 2026

Study Completion Date

June 15, 2027

Conditions
Primary Central Nervous System Lymphoma
Interventions
DRUG

Isavuconazole

Isavuconazole to begin at least 3 days prior to ibrutinib and continue throughout chemotherapy (cycles 1-6)

DRUG

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)

BIOLOGICAL

Rituximab

Rituximab (R) given with TEDD and TEDDI every 3 weeks for cycles 1-6 (all arms)

DRUG

Cytarabine

Cytarabine given via Ommaya reservoir (IT therapy) on days 1 and day 5 of cycles 2-6 (all arms)

DRUG

TEDD

Temozolomide, etoposide, doxil, dexamthasone, (TEDD) given on first cycle (Arm 1-A)

DRUG

Ibrutinib (Arms 2, 3 and 4)

Ibrutinib given on day -3 to day -1 on cycle 1 (Arms 2, 3 and 4)

DRUG

Methotrexate

Methotrexate on days 1 and day 5 of cycles 2-6 (Arm 4)

DRUG

Ibrutinib (Arm 1 - Closed with Amendment G)

Ibrutinib given on day -14 to day -1 on cycle 1 (Arm 1)

DRUG

Ibrutinib (Arm 4)

Ibrutinib given on days 1-10 for cycles 1-6 (Arm 4)

Trial Locations (1)

20892

RECRUITING

National Institutes of Health Clinical Center, Bethesda

All Listed Sponsors
lead

National Cancer Institute (NCI)

NIH