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NOT YET RECRUITING
NCT07719855
PHASE3

A Multicenter, Prospective, Open-Label, Randomized Controlled Clinical Study of Orelabrutinib Combined With Obinutuzumab and Lenalidomide Versus Obinutuzumab Plus Chemotherapy for Treatment-Naive Follicular Lymphoma

Sponsor: Ruijin Hospital

View on ClinicalTrials.gov

Summary

This study intends to conduct a prospective, multicenter, open-label, randomized controlled clinical trial to systematically evaluate the efficacy and safety of the orelabrutinib plus obinutuzumab and lenalidomide (RO2) regimen versus the obinutuzumab-combined chemotherapy (O-chemo) regimen in patients with previously untreated follicular lymphoma. The primary observation is whether the RO2 regimen can maintain or improve therapeutic efficacy while significantly reducing hematological toxicities and other related adverse reactions, so as to provide a novel therapeutic option for improving the prognosis and quality of life of patients with follicular lymphoma (FL).

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

652

Start Date

2026-07

Completion Date

2033-12

Last Updated

2026-07-22

Healthy Volunteers

No

Interventions

DRUG

Orelabrutinib

Orelabrutinib PO will be administered as per the schedule specified in the respective arm.

DRUG

obinutuzumab

Obinutuzumab IV infusion will be administered as per the schedule specified in the respective arm.

DRUG

Lenalidomide

Lenalidomide PO will be administered as per the schedule specified in the respective arm.

DRUG

Cyclophosphamide

Cyclophosphamide IV infusion will be administered as per the schedule specified in the respective arm.

DRUG

Doxorubicin

Doxorubicin IV infusion will be administered as per the schedule specified in the respective arm.

DRUG

Prednisone

Prednisone PO will be administered as per the schedule specified in the respective arm.

DRUG

Vincristine

Vincristine infusion will be administered as per the schedule specified in the respective arm.

DRUG

Bendamustine

Bendamustine infusion will be administered as per the schedule specified in the respective arm.

Locations (1)

Ruijin Hosiptal

Shanghai, Shanghai Municipality, China