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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
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
Conditions
Interventions
Orelabrutinib
Orelabrutinib PO will be administered as per the schedule specified in the respective arm.
obinutuzumab
Obinutuzumab IV infusion will be administered as per the schedule specified in the respective arm.
Lenalidomide
Lenalidomide PO will be administered as per the schedule specified in the respective arm.
Cyclophosphamide
Cyclophosphamide IV infusion will be administered as per the schedule specified in the respective arm.
Doxorubicin
Doxorubicin IV infusion will be administered as per the schedule specified in the respective arm.
Prednisone
Prednisone PO will be administered as per the schedule specified in the respective arm.
Vincristine
Vincristine infusion will be administered as per the schedule specified in the respective arm.
Bendamustine
Bendamustine infusion will be administered as per the schedule specified in the respective arm.
Locations (1)
Ruijin Hosiptal
Shanghai, Shanghai Municipality, China