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
Recruiting
Apply to this trial

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

Start date
Feb 22, 2019
Status verified
May 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 ]

Central Contacts

Locations (8)

FacilityCityStateZIPSite coordinators
Northwestern UniversityEvanstonIllinois60208
Leo Gordon, MD
312-695-4546
Massachusetts General Hospital (Data Collection and Specimen Analysis)BostonMassachusetts02114
Jacob D Soumerai, MD
617-724-4000
Memorial Sloan Kettering at Basking RidgeBasking RidgeNew Jersey07920
Andrew Zelenetz, MD
212-639-2656
Memorial Sloan Kettering MonmouthMiddletownNew Jersey07748
Andrew Zelenetz, MD, PhD
212-639-2656
Memorial Sloan Kettering CommackCommackNew York11725
Helena Yu, MD
646-888-4274
Memorial Sloan Kettering WestchesterHarrisonNew York10604
Andrew Zelenetz, MD, PhD
212-639-2656
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065
Andrew Zelenetz, MD, PhD
212-639-2656
Anthony Mato, MD
212-639-8596
Andrew Zelenetz, MD, PhD (PRINCIPAL_INVESTIGATOR)
Memorial Sloan Kettering NassauUniondaleNew York11553
Andrew Zelenetz, MD, PhD
212-639-2656

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· Harrison, NY

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