Actively Recruiting
Sonrotoclax, Zanubrutinib and CD20mab in Untreated MCL Patients
Led by Tianjin Medical University Cancer Institute and Hospital · Updated on 2025-05-11
30
Participants Needed
1
Research Sites
256 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a an open-label, multi-center, single-arm study to evaluate the efficacy and safety of sonrotoclax, zanubrutinib and CD20mab in untreated MCL patients.
CONDITIONS
Official 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
- No prior treatment for MCL
- Eastern Cooperative Oncology Group (ECOG) performance score of 2 or less
- Men and women of childbearing potential agree to use effective contraception during and for 90 days after treatment
- Adequate bone marrow function: Absolute Neutrophil Count (ANC) ≥ 1.0 x 10^9/L; Platelets ≥ 75,000/mm3 (or ≥ 50,000/mm3 if bone marrow involved) within 7 days
- Adequate coagulation, renal, and hepatic function within specified laboratory ranges
- Signed informed consent according to Good Clinical Practice and national regulations
You will not qualify if you...
- Known central nervous system involvement by MCL
- Prior malignancy other than MCL within past 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 or need for long-term use
- Prior stem cell transplant or CAR-T therapy within defined recent periods or active graft-vs-host disease requiring immunosuppressants
- Major surgery within 4 weeks before screening
- Clinically significant cardiovascular disease including recent heart attack, unstable angina, severe heart failure, serious arrhythmias, prolonged QTc interval, certain heart blocks, or uncontrolled high blood pressure
- Previous exposure to BCL2 or BTK inhibitors
- Known hypersensitivity to sonrotoclax excipients
- Unresolved hepatitis B or C infection or known HIV infection without proper viral control
- Inability to swallow capsules or significant gastrointestinal disorders affecting absorption
- Pregnancy or lactation
- Stroke or brain bleeding within 6 months before starting study drug
- Other medical conditions that could make study drug unsafe or affect interpretation of results
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
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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