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NCT06704555

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

Recruiting now Phase 2 Last updated 24 November 2024
What this trial tests

Phase 2 trial testing radiation therapy in Follicular Lymphoma in 20 participants. Currently enrolling.

Timeline
20 December 2024
Primary endpoint
1 December 2025
30 December 2027

Quick facts

Lead sponsorTianjin Medical University Cancer Institute and Hospital
PhasePhase 2
StatusRecruiting now
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment20
Start date20 December 2024
Primary completion1 December 2025
Estimated completion30 December 2027
Sites1 location across China

Drugs / interventions tested

Conditions studied

Sponsor

Tianjin Medical University Cancer Institute and Hospital

Who can join

Adults 18 to 70, any sex, with Follicular Lymphoma. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other trials of radiation therapy

Trials testing the same drug.

Other recruiting trials for Follicular Lymphoma

Currently open trials in the same condition.

Other Tianjin Medical University Cancer Institute and Hospital trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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