Zanubrutinib with G-CVP for untreated Follicular Lymphoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to evaluate the efficacy and safety of zanubrutinib combined with obinutuzumab and the chemotherapy regimen G-CVP in patients with previously untreated follicular lymphoma. The study will assess how well this combination works and its safety profile, particularly focusing on patients' minimal residual disease (MRD) status after treatment. Participants will receive the treatment and maintenance therapy based on their MRD status, addressing the need for improved therapeutic options in this patient population.

Why it matters

Who can join: the full rules

Inclusion Criteria:

Patients must meet all of the following criteria to be eligible:

1\. Histologically confirmed CD20-positive FL (grades 1, 2, or 3a), diagnosed according to the WHO 2022 criteria; 2, Clear indication for treatment: symptoms affecting normal work and life; end-organ dysfunction; cytopenia due to bone marrow involvement by lymphoma; bulky disease (per GELF criteria); persistent or rapidly progressive disease; 3. No prior systemic therapy for lymphoma; 4. Age 18-80 years; 5. Eastern cooperative oncology group (ECOG) performance status (PS) \< 2; 6. Expected survival \> 2 years; 7. At least one measurable lesion with a longest diameter ≥ 1.5 cm or extranodal lesion ≥ 1 cm; 8. Willingness to participate in the study and comply with treatment and follow-up.

Exclusion Criteria:

Patients will be excluded if they meet any of the following criteria:

1. Pregnant or breastfeeding women;
2. Abnormal liver or kidney function, defined as: serum direct/indirect bilirubin, alanine aminotransferase (ALT), aspartate aminotransferase (AST), or serum creatinine \> 2 × upper limit of normal (ULN); creatinine clearance \< 60 mL/min (unless due to lymphoma involvement);
3. History of deep vein thrombosis (DVT) or pulmonary embolism (PE) within the past 12 months;
4. Absolute neutrophil count (ANC) \< 1.5 × 10⁹/L, platelets \< 75 × 10⁹/L, or hemoglobin \< 70 g/L (unless due to bone marrow involvement by lymphoma);
5. Long-term use of strong or moderate CYP3A inducers;
6. Known hypersensitivity to any component of the study drug;
7. Other active malignancies, except: cured non-melanoma skin cancer, cervical carcinoma in situ, localized prostate cancer, superficial bladder cancer, ductal carcinoma in situ, or other malignancies with disease-free survival \> 5 years;
8. Severe concurrent infections;
9. Drug abuse, medical, psychological, or social conditions that may interfere with study participation or result evaluation;
10. Investigator-deemed ineligibility for the study.

Where it's running

• Cancer Hospital Chinese Academy of Medical Sciences
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Study coordinator: Zhitao Ying
• Email: yingzhitao001@163.com
• Phone: 008613811818096

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Venetoclax plus Zanubrutinib for CLL/SLL in frontline or previously treated patients

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• MRD-guided Zanubrutinib + Sonrotoclax in new high-risk CLL/SLL

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  Recruiting Phase 2 The First Affiliated Hospital with Nanjing Medical University · Nanjing, Jiangsu · NCT07608978

• SCTB35 plus Lenalidomide for relapsed or refractory follicular lymphoma

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.