Radiotherapy Followed by Tiselizumab Combined With RCHOP in Previously Untreated Bulky Follicular Lymphoma
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.
Timeline
- Start
- 2024-12-20
- Primary completion
- 2025-12
- Completion
- 2027-12-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Tiselizumab | Unknown | 200 mg | Intravenous |
| Background | Cyclophosphamide | Other / unclassified | 750 mg/m2 | Intravenous |
| Background | Doxorubicin | Other / unclassified | 50 mg/m2 | Intravenous |
| Background | Prednisone | Other / unclassified | 100 mg | Oral |
| Background | Rituximab | Monoclonal antibody | 375 mg/m2 | Intravenous |
| Background | Vincristine | Small molecule | 1.4 mg/m2 | Intravenous |