Actively Recruiting
Obinutuzumab, Zanubrutinib, and Lenalidomide in First-line Treatment of Mantle Cell Lymphoma
Led by Institute of Hematology & Blood Diseases Hospital, China · Updated on 2026-05-13
37
Participants Needed
2
Research Sites
188 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a prospective, open-label, single-arm clinical trial evaluating a treatment strategy for previously untreated Mantle Cell Lymphoma (MCL). The study will enroll patients who have not received prior systemic therapy for MCL. All patients will receive the ZGR induction regimen. Risk-adapted maintenance therapy will be applied: non-high-risk patients will receive lenalidomide and zanubrutinib maintenance for 1 and 2 years, respectively; high-risk patients will undergo CAR-T cell therapy followed by the same maintenance regimen. The primary objective is to assess the feasibility and preliminary efficacy of this treatment approach in the first-line setting of MCL.
CONDITIONS
Official Title
Obinutuzumab, Zanubrutinib, and Lenalidomide in First-line Treatment of Mantle Cell Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 80 years inclusive
- Diagnosis of Mantle Cell Lymphoma confirmed by tissue or cell analysis with at least one measurable lesion
- No prior systemic therapy for Mantle Cell Lymphoma
- ECOG performance status of 0 to 2
- Adequate organ function including: neutrophil count ≥ 1 × 10⁹/L without recent transfusions or growth factor support, platelet count ≥ 75 × 10⁹/L, total bilirubin ≤ 2.0 times upper limit of normal, ALT and AST ≤ 2.0 times upper limit of normal, creatinine clearance ≥ 30 mL/min, and left ventricular ejection fraction ≥ 50%
- Negative pregnancy test within 7 days before starting treatment for females of childbearing potential
- Agreement to use effective contraception during the study and for 6 months after last dose if applicable
- Willing and able to provide informed consent and comply with follow-up requirements
You will not qualify if you...
- Known involvement of central nervous system including brain or meningeal lymphoma
- Congestive heart failure with NYHA Class III or IV
- History of other primary cancers within 3 years except certain treated or localized cancers
- Prior treatment with investigational drugs
- Active systemic infections requiring antimicrobial therapy within 2 weeks before treatment
- Use of immunosuppressive agents within 7 days before treatment except low-dose corticosteroids or inhaled/intranasal steroids
- Severe allergic reactions or intolerance to monoclonal antibodies or study drugs
- Presence of immunodeficiency diseases such as active hepatitis B or C, HIV, or pregnancy or breastfeeding
- Inability or unwillingness to use contraception if of childbearing potential
- Any condition that may affect safety or study compliance as judged by the investigator
- Other conditions deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
Institute of Hematology & Blood Diseases Hospital
Tianjin, Tianjin Municipality, China, 300020
Not Yet Recruiting
2
Institute of Hematology and Blood Diseases Hospital ,Chinese Academy of Medical Sciences
Tianjin, Tianjin Municipality, China, 300020
Actively Recruiting
Research Team
S
Shuhua Yi, Doctor
CONTACT
L
Lugui Qiu, Doctor
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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