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

Part of paid clinical trials in Evanston, Illinois.

Sponsor
Memorial Sloan Kettering Cancer Center
Study ID
NCT03824483
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Chronic Lymphocytic Leukemia (CLL)
  • Small Lymphocytic Leukemia (SLL)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Zanubrutinib — DRUG
    zanubrutinib (160mg by mouth BID)
  • Obinutuzumab — DRUG
    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).
  • Venetoclax — DRUG
    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.

Study Details

The purpose of this study is to determine the rate of minimum residual disease (MRD) negative response (i.e. the rate of no evidence of disease) of the study drugs, zanubrutinib, obinutuzumab, and venetoclax, given in combination as a treatment for CLL and/or SLL.

Key Dates

First listed
Jan 31, 2019
Start date
Feb 22, 2019
Status verified
Sep 2026
Primary completion
Feb 28, 2027
Completion
Feb 28, 2027

Study Design

Enrollment
230 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: BOVEN regimen
    Patients will be given zanubrutinib (160mg by mouth BID) and 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). 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.

Primary Outcome Measure

establish the rate of minimum residual disease (MRD) undetectable response [ Time Frame: 1 year ]

Locations (8)

FacilityCityStateZIPSite coordinators
Northwestern UniversityEvanstonIllinois60208-
Massachusetts General Hospital (Data Collection and Specimen Analysis)BostonMassachusetts02114-
Memorial Sloan Kettering at Basking RidgeBasking RidgeNew Jersey07920-
Memorial Sloan Kettering MonmouthMiddletownNew Jersey07748-
Memorial Sloan Kettering CommackCommackNew York11725-
Memorial Sloan Kettering WestchesterEast White PlainsNew York10604-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-
Memorial Sloan Kettering NassauUniondaleNew York11553-

Find similar trials in Evanston, IL

By research site
Northwestern University· Evanston, ILMassachusetts General Hospital (Data Collection and Specimen Analysis)· Boston, MAMemorial Sloan Kettering at Basking Ridge· Basking Ridge, NJMemorial Sloan Kettering Monmouth· Middletown, NJMemorial Sloan Kettering Commack· Commack, NYMemorial Sloan Kettering Westchester· East White Plains, NY

Related Studies