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Trial Title:
Zanubrutinib, Obinutuzumab and Lenalidomide (ZGR) in High-risk Treatment-naive Patients with Follicular Lymphoma (FL)
NCT ID:
NCT06549335
Condition:
Follicular Lymphoma
Conditions: Official terms:
Lymphoma
Lymphoma, Follicular
Lenalidomide
Obinutuzumab
Zanubrutinib
Conditions: Keywords:
Zanubrutinib
Lymphoma
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Zanubrutinib, Obinutuzumab and Lenalidomide (ZGR)
Description:
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.
Arm group label:
Experimental: Zanubrutinib, Obinutuzumab and Lenalidomide (ZGR)
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
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Address:
City:
Shanghai
Country:
China
Start date:
December 1, 2024
Completion date:
December 31, 2026
Lead sponsor:
Agency:
Ruijin Hospital
Agency class:
Other
Source:
Ruijin Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06549335
