A Phase 2 Trial Of The Combination Of Zanubrutinib, Sonrotoclax, And Obinutuzumab For Patients Wi… (NCT07674810) | Clinical Trial Compass
Not Yet RecruitingPhase 2
A Phase 2 Trial Of The Combination Of Zanubrutinib, Sonrotoclax, And Obinutuzumab For Patients With Treatment-Naïve Chronic Lymphocytic Leukemia
United States40 participantsStarted 2026-12-31
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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
. Adequate renal function a. Adequate renal function defined by a value ≥30 mL/min determined via estimated GFR calculated according to the CKD-EPI equation
. Adequate hematologic function
. Adequate coagulation function a. INR ≤1.5 x ULN and aPTT ≤1.5 x ULN
. Ability to swallow tablets and comply with outpatient treatment, laboratory monitoring, and required clinic visit for the duration of study participation
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Safety and Adverse Events (AEs)
Timeframe: Through study completion; an average of 1 year
. 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.