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

PHASE1/PHASE2RecruitingINTERVENTIONAL
Enrollment

145

Participants

Timeline

Start Date

February 9, 2018

Primary Completion Date

December 1, 2025

Study Completion Date

December 1, 2026

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

Venetoclax

Administered orally, days 2-14, at varying doses of 200-800 mg (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

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

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

Revlimid (lenalidomide)

Administered orally, days 1-15, at a dose of 15 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