This phase III trial aims to compare the efficacy and safety of MIL62 combined lenalidomide and lenalidomide alone to treat patient diagnosed with Follicular Lymphoma (FL) and refractory to rituximab. The study randomized patients with a 1:1 ratio to receive either MIL62 plus lenalidomide or lenalidomide.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
168
The patients confirming to the eligibility criteria will receive MIL62 from cycle 1 to cycle 30 and lenalidomide from cycle 1 to cycle 18, unless either rapid disease progression or unacceptable toxicity was observed.
The patients confirming to the eligibility criteria will receive lenalidomide for 18 cycles, unless either rapid disease progression or unacceptable toxicity was observed.
Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, China
RECRUITINGProgression-free Survival (per IRC)
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years
Progression-free Survival (per Investigator)
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years
Overall Survival
Time frame: From date of randomization Until date of death from any cause for up to 5 years
Overall Response Rate (ORR)
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years
Kaplan-Meier Estimate of Duration of Response
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years
Percentage of Participants With Disease Control
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years
Number of Participants With Treatment Emergent Adverse Events
Time frame: up to the 1 month the last dose of last subject
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