Zanubrutinib, Obinutuzumab and Lenalidomide (ZGR) in High-risk Treatment-naive Patients with Follicular Lymphoma (FL)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Zanubrutinib, Obinutuzumab and Lenalidomide (ZGR).
- Who it may be relevant to
- Registry conditions: Follicular Lymphoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
The Efficacy and Safety of Zanubrutinib, Obinutuzumab and Lenalidomide (ZGR) Regimen in High-risk Treatment-naive Patients with Follicular Lymphoma
Overview
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
Interventions
- Drug Zanubrutinib, Obinutuzumab and Lenalidomide (ZGR)
Induction therapy: The ZGR regimen will be given from day 1 of each cycle of treatment. Each cycle will last for 28 days. Participants will receive a total of 6 cycles. Dosage: 1. Zanubrutinib, 160 mg bid, po, day 1-28; 2. Obinutuzumab, 1000mg, ivgtt, day 1/8/15 (C1), day1 (C2-6); 3. Lenalidomide, 25 mg qd, po, day 2-11. Maintenance therapy: 1. Obinutuzumab, ivgtt,1000mg, every 3 months for 2 years; 2. Lenalidomide, 25mg, PO, during 1-10 days in every 28 days for 6 cycles.
Primary outcome measures
- Objective response rate (ORR) [Time frame: At the end of Cycle 6 (each cycle is 28 days)]
Secondary outcome measures (5)
- Complete response rate (CR) [Time frame: At the end of Cycle 6 (each cycle is 28 days)]
- Partial response rate (PR) [Time frame: At the end of Cycle 6 (each cycle is 28 days)]
- Duration of response [Time frame: Baseline up to data cut-off (up to approximately 2 years)]
- 2-year progression free survival rate [Time frame: Baseline up to data cut-off (up to approximately 2 years)]
- 2-year overall survival rate [Time frame: Baseline up to data cut-off (up to approximately 2 years)]
Eligibility criteria
Inclusion criteria
- 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 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Ruijin Hospital, Shanghai Jiao Tong University School of Medicine — Shanghai
Identifiers
NCT: NCT06549335 · FL-ZGR