Radiotherapy Followed by Tiselizumab Combined With RCHOP in Previously Untreated Bulky Follicular Lymphoma

This was a single center, single arm, phase II study. Patients with previously untreated follicular lymphoma were enrolled from the department of lymphoma, Tianjin Medical University Cancer Institute and Hospital. The bulky disease was received radiation (dose:18～24Gy) before RCHOP. Patients began chemoimmunotherapy 1～2 weeks later than radiation. Treatment included Tiselizumab (200 mg iv d1) plus R-CHOP (rituximab 375 mg/m2 intravenous \[IV\] day 2, cyclophosphamide 750 mg/m2 IV day 3, doxorubicin 50 mg/m2 IV day 3, vincristine 1.4 mg/m2 \[maximum 2.0 mg total\] IV day 3, and prednisone 100 mg oral days 3-7, 21～28 days for one cycle ) for six cycles. Rituximab was given every 2 months to patients who were complete metabolic response /partial metabolic response（CMR/PMR）after first-line chemo until 2 years. Response was assessed by PET/CT scan after cycle 4 and cycle 6.

NCT Number	NCT06704555
Lead Sponsor	Tianjin Medical University Cancer Institute and Hospital
Conditions	Follicular Lymphoma
Enrollment	20 participants
Start Date	2024-12-20
Primary Completion	2025-12 (estimated)
Study Completion	2027-12-30 (estimated)
Updated on ClinicalTrials.gov	2024-11-26