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

ConditionsChronic Lymphocytic Leukemia (CLL)Small Lymphocytic Leukemia (SLL)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMemorial Sloan Kettering Cancer Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Ability and willingness to comply with the requirements of the study protocol

Age ≥18 years

Diagnosis of the following histories according to the WHO criteria

CLL or SLL

Disqualifiers

Known active histological transformation from CLL to an aggressive lymphoma (i.e., Richter"s transformation)

Active malignancy or systemic therapy for another malignancy within 3 years; local/regional therapy with curative intent such as surgical resection or localized radiation within 3 years of treatment is permitted

Other diagnosis of active cancer

Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) at study enrollment, or any major episode of infection requiring treatment with IV antibiotics or hospitalization (relating to the completion of the course of antibiotics) within 4 weeks prior to Cycle 1, Day 1

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

230 Participants
are divided into 1 treatment group
Group A: BOVEN regimenExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

establish the rate of minimum residual disease (MRD) undetectable response

Patients will have their minimum residual disease (MRD) response classified by bone marrow peripheral blood flow cytometry with a sensitivity of 10-4.

Time frame
1 year

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Memorial Sloan Kettering Cancer Center

Lead sponsor

Roche-Genentech

Collaborator

Massachusetts General Hospital

Collaborator

BeOne Medicines

Collaborator

Source ClinicalTrials.gov
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