Zanubrutinib with G-CVP for untreated Follicular Lymphoma

Efficacy and Safety of Zanubrutinib Combined With G-CVP Regimen in Previously Untreated Follicular Lymphoma

This study is testing if a new combination of zanubrutinib, obinutuzumab, and chemotherapy can help people with untreated follicular lymphoma feel better and stay healthy.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences (other)
• Drugs / interventions: obinutuzumab, zanubrutinib, cyclophosphamide, prednisone, rituximab, chemotherapy
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT06959732 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-80 with histologically confirmed CD20-positive follicular lymphoma requiring treatment.

Not a fit: Patients with prior systemic therapy for lymphoma or those with significant liver or kidney dysfunction may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a more effective and safer option for patients with follicular lymphoma.

How similar studies have performed: Other studies have shown promising results with similar combinations of therapies in treating follicular lymphoma, indicating potential for success.

Eligibility criteria

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 this trial is running

Beijing, Beijing Municipality

• Cancer Hospital Chinese Academy of Medical Sciences — Beijing, Beijing Municipality, China (RECRUITING)

Study contacts

• Study coordinator: Zhitao Ying

Conditions: Follicular Lymphoma, Zanubrutinib, Obinutuzumab, CVP