Zanubrutinib, Obinutuzumab and Lenalidomide (ZGR) in High-risk Treatment-naive Patients with Follicular Lymphoma (FL)

Shanghai Jiao Tong University

Status and phase: Not yet enrolling; Phase 2

Conditions: Follicular Lymphoma

Treatments: Drug: Zanubrutinib, Obinutuzumab and Lenalidomide (ZGR)

Study type: Interventional

Funder types: Other

Identifiers

NCT06549335

FL-ZGR

Details and patient eligibility

About

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-naive patients with follicular lymphomas

Enrollment: 66 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Pathologically confirmed CD20 positive follicular lymphoma grade 1, 2, or 3A based on 2016 WHO classification
2. Treatment naive
3. Age ≥ 18 years
4. Indications for treatment confirmed
5. Identified as high-risk group by Follicular Lymphoma International Prognostic Index 2 (FLIPI2) at enrollment
6. Must has measurable lesion in CT or PET-CT prior to treatment
7. Considered suitable for ZGR regimens
8. Informed consented

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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66 participants in 1 patient group

Experimental: Zanubrutinib, Obinutuzumab and Lenalidomide (ZGR)

Experimental group

Treatment:

Drug: Zanubrutinib, Obinutuzumab and Lenalidomide (ZGR)