Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, and Revlimid in Combination With Polatuzumab (ViPOR-P) in Relapsed/Refractory B-cell Lymphoma

PHASE1RecruitingINTERVENTIONAL
Enrollment

55

Participants

Timeline

Start Date

July 9, 2021

Primary Completion Date

April 4, 2026

Study Completion Date

April 4, 2031

Conditions
LymphomaNon-Hodgkin LymphomaDiffuse Large B-Cell LymphomaBurkitt Lymphoma
Interventions
BIOLOGICAL

obinutuzumab

administered intravenously, days 1 and 2, at a dose of 1000 mg; every 21 days for up to 6 cycles, or until disease progression or unacceptable toxicity

DRUG

prednisone

administered orally, days 1-7, at a dose of 100 mg; every 21 days for up to 6 cycles, or until disease progression or unacceptable toxicity

DRUG

Revlimid

administered orally, days 1 and 14, at a dose of 15 mg; every 21 days for up to 6 cycles, or until disease progression or unacceptable toxicity

BIOLOGICAL

Polatuzumab

administered intravenously, on day 2, at varying doses of 1.4-1.8 mg/kg (based upon assigned dose level); every 21 days for up to 6 cycles, or until disease progression or unacceptable toxicity

DRUG

ibrutinib

administered orally, days 1-14, at a dose of 560 mg; every 21 days for up to 6 cycles, or until disease progression or unacceptable toxicity

DRUG

venetoclax

administered orally, days 2-14, at a dose of 800 mg; every 21 days for up to 6 cycles, or until disease progression or unacceptable toxicity

Trial Locations (1)

20892

RECRUITING

National Institutes of Health Clinical Center, Bethesda

All Listed Sponsors
lead

National Cancer Institute (NCI)

NIH