This study is a randomized, controlled, double-blind, multicenter, phase III clinical study to evaluate the efficacy of IMM0306 (Amulirafusp Alfa)in combination with lenalidomide versus placebo in combination with lenalidomide in patients with Relapsed/Refractory Follicular lymphoma. Primary endpoints are Complete Remission Rate (CRR) and Progression-Free Survival (PFS).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
198
Beijing Cancer Hospital
Beijing, China
Complete remission rate(CRR) as Assessed by Investigator
CRR is defined as the percentage of participants who achieve a CR(Complete Response) determined per Lugano 2014 criteria (2014 Lugano Revised Response Criteria for Malignant Lymphoma).
Time frame: approximately 48 months
Progression-Free Survival (PFS) as Assessed by Investigator
PFS is defined as the time from randomization to the first documented disease progression or death due to any cause, whichever occurs first.
Time frame: approximately 48 months
Complete remission rate(CRR) as Assessed by Independent Review Committee(IRC)
CRR is defined as the percentage of participants who achieve a CR determined per Lugano 2014 criteria.
Time frame: approximately 48 months
Progression-Free Survival (PFS) as Assessed by Independent Review Committee(IRC)
PFS is defined as the time from randomization to the first documented disease progression or death due to any cause, whichever occurs first.
Time frame: approximately 48 months
Objective Response Rate (ORR)
ORR is defined as the proportion of the analysis population achieving CR, PR(Partial Response).
Time frame: approximately 48 months
Duration of Response (DOR)
DOR is defined as the time from the first documented evidence of complete response or partial response until disease progression or death due to any cause, whichever occurs first.
Time frame: approximately 48 months
Overall Survival (OS)
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OS is defined as the time from randomization to death due to any cause.
Time frame: approximately 60 months
Time to Next Anti-Lymphoma Treatment(TTNT)
TTNT is defined as the number of days from randomization to the date of next anti-lymphoma treatment.
Time frame: approximately 48 months
Adverse Event (AE)
An AE is any untoward medical occurrence in a clinical study participant temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Time frame: approximately 48 months