Actively Recruiting
An Open-label, Multi-center, Single-arm Study to Evaluate the Efficacy and Safety of Sonrotoclax, Zanubrutinib and CD20mab in Untreated Mantle Cell Lymphoma Patients
Led by Tianjin Medical University Cancer Institute and Hospital · Updated on 2025-05-11
30
Participants Needed
1
Research Sites
30 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a combination of sonrotoclax, zanubrutinib, and CD20 monoclonal antibody (CD20mab) in patients with untreated Mantle Cell Lymphoma (MCL). This open-label, multi-center, single-arm Phase 2 study aims to explore a chemo-free immunotherapy regimen for newly diagnosed MCL patients who may not tolerate traditional chemotherapy well. The study seeks to balance treatment effectiveness and safety in this patient population. Participants will receive sonrotoclax orally at a dose of 320 mg once daily following a ramp-up schedule, zanubrutinib orally at a total daily dose of 320 mg, and CD20mab, recommended as rituximab at 375 mg/m2, administered from cycle 1 to cycle 12. Each treatment cycle lasts 28 days, and the regimen is designed to be given over 12 cycles. Other CD20 monoclonal antibodies may also be used as per protocol. During the study, participants will be monitored for treatment response, including complete response rate at the end of cycle 12. Researchers will also evaluate overall response rate up to cycle 36 and overall survival for up to 36 months. Assessments will include clinical evaluations, laboratory tests to monitor organ function and blood counts, and safety monitoring throughout treatment and follow-up. Informed consent and adherence to contraceptive measures for participants of child-bearing potential are required for participation.
CONDITIONS
Brief Title
Sonrotoclax, Zanubrutinib and CD20mab in Untreated MCL Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Confirmed diagnosis of Mantle Cell Lymphoma (MCL) according to WHO 2008 criteria
- Previously untreated Mantle Cell Lymphoma
- Eastern Cooperative Oncology Group (ECOG) performance score of 2 or less
- Agreement to use highly effective contraceptives for men and women of child-bearing potential during study and for 90 days after last dose
- Adequate bone marrow function with ANC 1.0 x 10^9/L and platelets 75,000/mm3 (or 50,000/mm3 if bone marrow lymphoma involvement) within 7 days
- Adequate coagulation, renal, and hepatic function per lab reference ranges
- Signed informed consent according to GCP and national regulations
You will not qualify if you...
- Known central nervous system involvement by Mantle Cell Lymphoma
- Prior malignancy within 3 years except certain treated skin, bladder, cervical, breast, or prostate cancers
- Use of moderate or strong CYP3A4 inhibitors or inducers within 2 weeks before study drug start or requiring long-term use
- Recent stem cell transplant or CAR-T therapy within last 3 to 6 months or active graft-versus-host disease
- Major surgery within 4 weeks before screening
- Significant cardiovascular disease including recent heart attack, unstable angina, severe heart failure, arrhythmias, prolonged QTc, heart block, or uncontrolled hypertension
- Prior exposure to BCL2 or BTK inhibitors
- Hypersensitivity to sonrotoclax excipients
- Unresolved hepatitis B or C infection or known HIV-positive
- Unable to swallow capsules or significant gastrointestinal disorders
- Pregnant or lactating women
- Stroke or intracranial hemorrhage within 6 months before first dose
- Underlying medical conditions that may interfere with study drug safety or data interpretation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 12 cycles of 28 days each
Participants receive a combination of sonrotoclax, zanubrutinib, and CD20mab over multiple treatment cycles.
Regular visits during each 28-day cycle for treatment administration and monitoring
Duration - Up to 36 months from enrollment
Participants are monitored for overall response and survival after completing treatment.
Periodic visits for assessment of overall survival and disease status
Trial Site Locations
Total: 1 location
1
Tianjin Medical University Cancer Institute and Hospital
Tianjin, China
Actively Recruiting
Research Team
H
Huilai Zhang, MD, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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