Study of Zanubrutinib, Obinutuzumab, and Venetoclax in Patients With Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Leukemia (SLL)

PHASE2RecruitingINTERVENTIONAL
Enrollment

230

Participants

Timeline

Start Date

February 22, 2019

Primary Completion Date

February 28, 2026

Study Completion Date

February 28, 2026

Conditions
Chronic Lymphocytic Leukemia (CLL)Small Lymphocytic Leukemia (SLL)
Interventions
DRUG

Zanubrutinib

zanubrutinib (160mg by mouth BID)

DRUG

Obinutuzumab

"obinutuzumab (1000mg IVPB on Days 1\*, 8 and 15 of Cycle 1 and on Day 1 of Cycles 2 through 8) starting on Cycle 1 (28-day cycles). \* On Cycle 1, obinituzumab will be administered in split dose at 100mg IVPB on Day 1 and 900mg IVPB on Day 2 in patients at increased risk for IRR (ALC \>25,000 cells/ul or baseline lymph nodes \>5 cm diameter)."

DRUG

Venetoclax

Venetoclax will be added to the regimen starting on Cycle 3, and will be incorporated into the regimen using the 5-week ramp-up schedule to mitigate the risk of tumor lysis syndrome (beginning at 20mg and gradually increasing to 400mg), and venetoclax will be administered a ta fixed dose level of 400mg by mouth daily of 28-day cycles thereafter.

Trial Locations (8)

10065

RECRUITING

Memorial Sloan Kettering Cancer Center, New York

10604

RECRUITING

Memorial Sloan Kettering Westchester, Harrison

11553

RECRUITING

Memorial Sloan Kettering Nassau, Uniondale

11725

RECRUITING

Memorial Sloan Kettering Commack, Commack

60208

RECRUITING

Northwestern University, Evanston

02114

RECRUITING

Massachusetts General Hospital (Data Collection and Specimen Analysis), Boston

07920

RECRUITING

Memorial Sloan Kettering at Basking Ridge, Basking Ridge

07748

RECRUITING

Memorial Sloan Kettering Monmouth, Middletown

All Listed Sponsors
collaborator

BeiGene USA, Inc.

INDUSTRY

collaborator

Roche-Genentech

INDUSTRY

collaborator

Massachusetts General Hospital

OTHER

lead

Memorial Sloan Kettering Cancer Center

OTHER

NCT03824483 - Study of Zanubrutinib, Obinutuzumab, and Venetoclax in Patients With Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Leukemia (SLL) | Biotech Hunter | Biotech Hunter