Zanubrutinib Combined With G-CVP in Previously Untreated FL

NCT06959732 | Recruiting Phase 2

• 1 other identifier: 24/548-4828
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn the efficacy and safety of zanubrutinib in combination with G-CVP in previously untreated follicular lymphoma patients The main questions it aims to answer are: (1) Efficacy and safety of patients receiving zanubrutinib, obinutuzumab combined with cyclophosphamide, vincristine, and prednisone (CVP) regimen. (2) The difference in efficacy of patients with different minimal residual disease (MRD) status after treatment. Participants will receive zanubrutinib combined with G-CVP, maintenance therapy will be determined by the MRD status after treatment.

Conditions

Follicular Lymphoma ( FL)

Keywords

Follicular Lymphoma ( FL); Zanubrutinib; Obinutuzumab; CVP

Outcome Measures

Primary Outcomes (1)

• CRR

  CRR (%) is defined as the number of patients achieving a complete response as a proportion of total patients evaluable for response.

  From date of enrollment until the date of first documented CR assessed up to 2.5 years.

Secondary Outcomes (3)

• ORR

  From date of enrollment until the date of first documented response assessed up to 2.5 years.

• PFS

  From date of enrollment until the date of first documented progression assessed up to 5 years.

• OS

  From date of enrollment until the date of first documented death assessed up to 5 years.

Study Arms (1)

ZG- CVP

EXPERIMENTAL

Zanubrutinib , obinutuzumab , cyclophosphamide , vincristine, and prednisone tablets were used every 21 days as a treatment cycle. Six cycles of treatment were completed, and the efficacy was reviewed every two cycles. Patients with progressive disease (PD) were excluded from the group. MRD was detected after six cycles. If MRD was negative, routine maintenance therapy was performed . If MRD was positive, Zanubrutinib was added to the conventional maintenance therapy for 12 months.

Drug: zanubrutinib, obinutuzumab,combined with CVP

Interventions

zanubrutinib, obinutuzumab,combined with CVP DRUG

Zanubrutinib (160 mg, twice daily \[bid\]), obinutuzumab (1000 mg on cycle 1 \[C1\], days 1, 8, and 15; on cycle 2 - 6 \[C 2-6\], day 1), cyclophosphamide (750 mg/㎡ on day 1), vincristine (1.4 mg/㎡, maximum dose 2 mg on day 1), and prednisone tablets (40 mg/㎡ once daily \[qd\] orally on days 1-5) were used every 21 days as a treatment cycle. Six cycles of treatment were completed, and the efficacy was reviewed every two cycles. Patients with PD were excluded from the group. MRD was detected after six cycles. If MRD was negative, routine maintenance therapy was performed (obinutuzumab 1000 mg once every 8 weeks, a total of 12 times). If MRD was positive, Zanubrutinib (160 mg, continuous bid) was added to the conventional maintenance therapy for 12 months.

ZG- CVP

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Patients will be excluded if they meet any of the following criteria:
• Pregnant or breastfeeding women;
• 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);
• History of deep vein thrombosis (DVT) or pulmonary embolism (PE) within the past 12 months;
• 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);
• Long-term use of strong or moderate CYP3A inducers;
• Known hypersensitivity to any component of the study drug;
• 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;
• Severe concurrent infections;
• Drug abuse, medical, psychological, or social conditions that may interfere with study participation or result evaluation;
• Investigator-deemed ineligibility for the study.

Sponsors & Collaborators

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences: lead

Study Sites (1)

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100021, China

RECRUITING

MeSH Terms

Conditions

Lymphoma, Follicular

Interventions

zanubrutinib; obinutuzumab; COP protocol 2

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Central Study Contacts

Zhitao Ying

CONTACT

008613811818096; yingzhitao001@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: chief physician

Study Record Dates

• First Submitted: April 25, 2025
• First Posted: May 7, 2025
• Study Start: January 1, 2025
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: May 7, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)