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.
Study 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-naive patients with follicular lymphomas
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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
Primary outcome measure(s)
Objective response rate (ORR) — At the end of Cycle 6 (each cycle is 28 days) Percentage of participants with overall response was determined on the basis of investigator assessments according to 2014 Lugano criteria
Trial sites (1)
Facility
City
Region
Status
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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