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RECRUITING
NCT06704555
PHASE2

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

Sponsor: Tianjin Medical University Cancer Institute and Hospital

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

20

Start Date

2024-12-20

Completion Date

2027-12-30

Last Updated

2024-11-26

Healthy Volunteers

No

Interventions

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

Locations (1)

Tianjin Cancer Hospital

Tianjin, Tianjin Municipality, China