Status:
NOT_YET_RECRUITING
Zanubrutinib, Obinutuzumab and Lenalidomide (ZGR) in High-risk Treatment-naive Patients with Follicular Lymphoma (FL)
Lead Sponsor:
Ruijin Hospital
Conditions:
Follicular Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This is a prospective, multiple-centers, open-label, single-arm clinical study designed to evaluate the efficacy and safety of Zanubrutinib, Obinutuzumab, and Lenalidomide (ZGR) in high-risk treatment...
Eligibility Criteria
Inclusion
- Pathologically confirmed CD20 positive follicular lymphoma grade 1, 2, or 3A based on 2016 WHO classification
- Treatment naive
- Age ≥ 18 years
- Indications for treatment confirmed
- Identified as high-risk group by Follicular Lymphoma International Prognostic Index 2 (FLIPI2) at enrollment
- Must has measurable lesion in CT or PET-CT prior to treatment
- Considered suitable for ZGR regimens
- Informed consented
Exclusion
- Transformed follicular lymphoma or 3B follicular lymphoma;
- HBsAg positive and / or HBcAb positive with HBV DNA titer; HCV antibody positive with HCV-RNA; or HIV positive
- Any drug contraindication in the treatment plan
- Pregnant or lactating women
- Patients judged by other researchers to be unsuitable for inclusion in the study
Key Trial Info
Start Date :
December 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT06549335
Start Date
December 1 2024
End Date
December 31 2026
Last Update
October 15 2024
Active Locations (1)
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1
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, China