This study investigates a fixed-duration regimen of zanubrutinib, bendamustine, and obinutuzumab (ZBG) in the treatment of treatment-naïve patients with advanced-stage follicular lymphoma. Patients will receive combination therapy with zanubrutinib, bendamustine, and obinutuzumab over 6 cycles, with each cycle lasting 28 days. The specific dosing schedule is as follows: Bendamustine 70 mg/m²: administered intravenously on Days 2-3 of Cycle 1, and on Days 1-2 of Cycles 2-6. Obinutuzumab 1000 mg: administered intravenously on Days 1, 8, and 15 of Cycle 1, and on Day 1 of Cycles 2-6 (every 28-day cycle). Zanubrutinib 160 mg orally twice daily (bid), continuously throughout Cycles 1-6. Treatment is discontinued after 6 cycles, with no subsequent maintenance therapy. Primary endpoint is 2-year PFS. Secondary endpoints include: CR rate after 6 cycles, ORR after 3 and 6 cycles MRD-negative rate after 3 and 6 cycles, OS, safety and tolerability.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
15
Patients will receive combination therapy with zanubrutinib, bendamustine, and obinutuzumab over 6 cycles, with each cycle lasting 28 days. The specific dosing schedule is as follows: Bendamustine 70 mg/m²: administered intravenously on Days 2-3 of Cycle 1, and on Days 1-2 of Cycles 2-6. Obinutuzumab 1000 mg: administered intravenously on Days 1, 8, and 15 of Cycle 1, and on Day 1 of Cycles 2-6 (every 28-day cycle). Zanubrutinib 160 mg orally twice daily (bid), continuously throughout Cycles 1-6. Treatment is discontinued after 6 cycles, with no subsequent maintenance therapy.
Jiangsu Province Hospital
Nanjing, Jiangsu, China
RECRUITING2-year PFS
2-year progression-free survival (PFS)
Time frame: 2 year
CR Rate
complete remission rate
Time frame: At the end of Cycle 6 (each cycle is 28 days)
ORR
objective remission rate
Time frame: At the end of Cycle 3 and 6 (each cycle is 28 days)
MRD
minimal residue rate
Time frame: At the end of Cycle 6 (each cycle is 28 days)
OS
Overall survival
Time frame: From date of randomization until the date of death from any cause, assessed up to 100 months
Number of Participants with Treatment-Related Adverse Events as Assessed by CTCAE
* Adverse events and serious adverse events * Treatment-related adverse events leading to dose adjustments, dose interruptions, delays, and/or study drug discontinuation
Time frame: 2 year
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