Follicular Lymphoma
Conditions
Keywords
Zanubrutinib, Lymphoma
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-naive patients with follicular lymphomas
Interventions
DRUGZanubrutinib, 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.
Sponsors
Ruijin Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Complete response rate (CR) | At the end of Cycle 6 (each cycle is 28 days) | Percentage of participants with complete response was determined on the basis of investigator assessments according to 2014 Lugano criteria. |
| Partial response rate (PR) | At the end of Cycle 6 (each cycle is 28 days) | Percentage of participants with complete response was determined on the basis of investigator assessments according to 2014 Lugano criteria. |
| Duration of response | Baseline up to data cut-off (up to approximately 2 years) | Time from first occurrence of documented CR or PR to disease progression/relapse, or death from any cause for participants with a response of CR or PR. Tumor assessments were performed with PET-CT. |
| 2-year progression free survival rate | Baseline up to data cut-off (up to approximately 2 years) | progression-free survival was defined as the time from the date of first treatment until the date of the first documented day of disease progression or relapse, using 2014 Lugano criteria, or death from any cause, whichever occurred first. |
| 2-year overall survival rate | Baseline up to data cut-off (up to approximately 2 years) | progression-free survival was defined as the time from the date of first treatment until the date of the first documented day of death from any cause. |
Countries
China
Contacts
Primary ContactWeili Zhao, M.D. and Ph.D
Backup ContactPengpeng Xu, M.D. and Ph.D
Outcome results
None listed