NCT06704555

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

A Study of the Radiotherapy Followed by Tiselizumab Combined With RCHOP in the Frontline Treatment of Follicular Lymphoma Patients With Bulky Disease

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Tianjin Medical University Cancer Institute and Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Follicular Lymphoma

Interventions

Type	Name	Description
RADIATION	radiation therapy	received radiation (dose:18～24Gy)
DRUG	Tiselizumab	200 mg iv day 1
DRUG	Rituximab	375 mg/m2 intravenous \[IV\] day 2
DRUG	Cyclophosphamide	750 mg/m2 IV day 3
DRUG	Doxorubicin	50 mg/m2 IV day 3
DRUG	Vincristine	1.4 mg/m2 \[maximum 2.0 mg total\] IV day 3
DRUG	Prednisone	100 mg oral days 3-7

Timeline

• Start date: 2024-12-20
• Primary completion: 2025-12-01
• Completion: 2027-12-30
• First posted: 2024-11-26
• Last updated: 2024-11-26

Locations

1 site across 1 country: China