This is a multicenter, phase 2, randomized trial to compare rituximab maintenance with observation after rituximab and lenalidomide (R2) induction therapy in patients with previously untreated marginal zone lymphoma. Patients who achieve complete response or partial response after R2 induction will be randomized to receive rituximab maintenance or observation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
144
Patients will receive R2 induction therapy consisting of rituximab and lenalidomide. Patients who achieve complete response or partial response after induction will receive rituximab maintenance every 8 weeks for up to 2 years.
Patients will receive R2 induction therapy consisting of rituximab and lenalidomide. Patients who achieve complete response or partial response after induction will undergo observation without maintenance anti-lymphoma therapy.
Sun yat-sen university cancer center
Guangzhou, Guangdong, China
2-year progression-free survival rate
The 2-year progression-free survival rate is defined as the proportion of patients who are alive without disease progression at 2 years after randomization.
Time frame: At 2 years after randomization
Complete response rate
Complete response rate is defined as the proportion of patients who achieve complete response according to the Lugano 2014 criteria during the maintenance or observation period.
Time frame: Up to 24 months after randomization
Overall response rate
Overall response rate is defined as the proportion of patients who achieve complete response or partial response according to the Lugano 2014 criteria during the maintenance or observation period.
Time frame: Up to 24 months after randomization
Duration of response
Duration of response is defined as the time from the first documented complete response or partial response to disease progression, relapse, or death from any cause, whichever occurs first.
Time frame: Up to 24 months after randomization
Overall survival
Overall survival is defined as the time from randomization to death from any cause.
Time frame: Up to 24 months after randomization
Event-free survival
Event-free survival is defined as the time from randomization to disease progression, relapse, initiation of new systemic anti-lymphoma therapy, or death from any cause, whichever occurs first.
Time frame: Up to 24 months after randomization
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Disease-free survival
Disease-free survival is defined as the time from the first documented complete response to disease relapse, progression, or death from any cause, whichever occurs first.
Time frame: Up to 24 months after randomization
Incidence of progression of disease within 24 months
POD24 is defined as the proportion of patients who experience disease progression, relapse, or death from any cause within 24 months from the start of frontline induction therapy.
Time frame: Within 24 months from the start of induction therapy
Patient-reported outcomes
Patient-reported outcomes will be assessed using the EORTC QLQ-C30 questionnaire.
Time frame: Up to 24 months after randomization
Incidence of adverse events and serious adverse events
The incidence and severity of adverse events and serious adverse events will be assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0.
Time frame: Up to 30 days after the last study treatment or during follow-up as clinically indicated