RecruitingPhase 2NCT06704555

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

Sponsor

Tianjin Medical University Cancer Institute and Hospital

Enrollment

20 participants

Start Date

Dec 20, 2024

Study Type

INTERVENTIONAL

Conditions

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.

Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new treatment approach for people with large-tumor ("bulky") follicular lymphoma (a slow-growing type of blood cancer) that has never been treated before: radiation first, followed by immunotherapy (tiselizumab) combined with standard R-CHOP chemotherapy. **You may be eligible if...** - You are between 18 and 75 years old - You have confirmed follicular lymphoma (grade 1, 2, or 3a) with a tumor measuring at least 7 cm - You have never had systemic (whole-body) treatment for lymphoma before - You meet standard criteria indicating treatment is needed - You are at Stage II, III, or IV and in reasonably good physical health **You may NOT be eligible if...** - Your lymphoma has transformed into a more aggressive form (diffuse large B-cell lymphoma) - You have lymphoma involving the brain or spinal fluid - Your blood counts or organ function are inadequate Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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