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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
652
Orelabrutinib PO will be administered as per the schedule specified in the respective arm.
Obinutuzumab IV infusion will be administered as per the schedule specified in the respective arm.
Lenalidomide PO will be administered as per the schedule specified in the respective arm.
Cyclophosphamide IV infusion will be administered as per the schedule specified in the respective arm.
Doxorubicin IV infusion will be administered as per the schedule specified in the respective arm.
Prednisone PO will be administered as per the schedule specified in the respective arm.
Vincristine infusion will be administered as per the schedule specified in the respective arm.
Bendamustine infusion will be administered as per the schedule specified in the respective arm.
Ruijin Hosiptal
Shanghai, Shanghai Municipality, China
Progression-free survival
PFS, defined as the time from diagnosis to the first occurrence of disease progression or relapse using the 2014 Lugano Response Criteria or death due to any cause, whichever occurs first; as determined by the investigator
Time frame: From enrollment to the first occurrence of disease progression or relapse, or death from any cause, whichever occurs earlier (a maximum of 6 years)
Complete response rate
CR rate at the end of treatment by FDG-PET defined as the proportion of participants with CR at the end of treatment according to the 2014 Lugano Response Criteria; as determined by the investigator and IRC (separately)
Time frame: End of treatment visit (6-8 weeks after last dose on Day 1 of Cycle 6 [Cycle length=21 days]
Objective response rate
ORR at treatment completion or discontinuation defined as the proportion of participants with CR or partial response (PR) at the end of treatment according to the 2014 Lugano Response Criteria; as determined by the investigator and IRC(separately)
Time frame: End of treatment visit (6-8 weeks after last dose on Day 1 of Cycle 6 [Cycle length=21 days]
Overall survival
OS defined as the time from diagnosis to death from any cause
Time frame: up to approximately 6 years
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v6.0
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v6.0
Time frame: From enrollment to study completion, a maximum of 6 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.