The goal of this clinical research study is to learn if the combination of zanubrutinib, sonrotoclax, and obinutuzumab can help to control previously untreated CLL/SLL.
Patients with a diagnosis of previously untreated CLL/SLL meeting iwCLL 2018 indication for treatment (Note: patients who receive steroids and/or CD20 mAb for cytoreduction in those patients presenting with significantly elevated WBC count or significant adenopathy/organomegaly and those who previously received steroids/CD20 mAb for immune cytopenias are eligible to enroll; Washout of 3 months applies for CD20 mAb and dose of prednisone (or equivalent) should be less than 20 mg/day by day 1 of study initiation)
Age greater than or equal to 18 years of age
Eastern Cooperative Oncology Group (ECOG) Performance status of 0-2
Adequate hepatic function a. Total bilirubin ≤1.5 x upper limit of normal (ULN) or ≤3 x ULN for patients with Gilbert's disease or documented disease involvement of liver (In pts with elevated total bilirubin due to increased indirect bilirubin, pts with direct bilirubin ≤1.5 x ULN are eligible) b. ALT and AST ≤3.0 x ULN, or ≤5.0 x ULN if documented disease involvement of liver
Correction of suspected drug-induced QTcF prolongation can be attempted at the investigator's discretion and only if clinically safe to do so with either discontinuation of the offending drug or switch to another drug not known to be associated with QTcF prolongation.
Correction for underlying bundle branch block (BBB) allowed. Note: Patients with pacemakers are eligible if they have no history of fainting or clinically relevant arrhythmias while using the pacemaker 12. Pregnancy, lactation or plan to breastfeed during the study or within 6 months of the last dose of study treatment 13. Concurrent use of warfarin or another vitamin K antagonist 14. Receiving treatment with a strong CYP3A inhibitor or strong CYP3A inducer ≤14 days or 5 half-lives, whichever is longer, before the first dose of study treatment(s) OR requiring long-term use of strong CYP3A inhibitors or inducers.
Single group
Zanubrutinib
DrugGiven orally
Obinutuzumab
DrugGiven orally
Sonrotoclax
DrugGiven orally
Safety and Adverse Events (AEs)
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
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M.D. Anderson Cancer Center
Lead sponsor
BeOne Medicines
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
