MIL62 Combined With Lenalidomide Versus Lenalidomide for Patients With Rituximab Refractory Follicular Lymphoma

Study Overview
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Brief Summary
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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.

Official Title
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A Multi-center, Open Label, Phase III Study to Evaluate the Efficacy and Safety of MIL62 Plus Lenalidomide Versus Lenalidomide in Subjects With Follicular Lymphoma Refractory to Rituximab

Conditions
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Follicular Lymphoma and Marginal Zone Lymphoma

Intervention / Treatment
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* Drug: Recombinant Humanized Monoclonal Antibody MIL62, lenalinomide
* Drug: lenalinomide


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients, >=18 years of age; Patients with either histologically documented CD20-positive FL, WHO grade 1, 2 or 3a Evidence of refractory to rituximab Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2 At least one bi-dimensionally measurable nodal or tumor lesion defined by CT scan as: greatest transverse diameter > 1.5 cm and a short axis ≥ 10mm Adequate hematologic function Life expectancy >5 years Able and willing to provide written informed consent and to comply with the study protocol Exclusion Criteria: Evidence of refractory to lenalinomide Central nervous system lymphoma Patients with progressive multifocalleukoencephalopathy (PML) Prior use of any antibody therapy(except for Rituximab ) within 3 months of study start Prior use of any anti-cancer vaccine Prior administration of radiotherapy 42 days prior to study entry Prior administration of chemotherapy 28 days prior to study entry History of prior malignancy within the last 3 years, with the exception of curatively treated basal or squamous cell carcinoma of the skin and low-grade in situ carcinoma of the cervix History of severe allergic or anaphylactic reactions to monoclonal antibody therapy Known hypersensitivity to thalidomide or lenalidomide Regular treatment with corticosteroids prior to the start of cycle 1, unless administered for indications other than NHL at a dose equivalent to < 20 mg/day prednisone Any serious active disease or co-morbid medical condition (such as New York Heart Association Class II or IV cardiac disease, severe arrhythmia, myocardial infarction within the last 6 months, unstable arrhythmias, or unstable angina) or pulmonary disease (including obstructive pulmonary disease and history of bronchospasm or other according to investigator's decision) Infection with human immunodeficiency virus (HIV), hepatitis B or hepatitis C(including HBsAg,HBcAb positive with abnormal HBV DAN or HCV RNA ) Pregnant or lactating females

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Recombinant Humanized Monoclonal Antibody MIL62, lenalinomide<br> | Drug: Recombinant Humanized Monoclonal Antibody MIL62, lenalinomide<br>* 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.<br>|
| Active Comparator: lenalinomide<br> | Drug: lenalinomide<br>* The patients confirming to the eligibility criteria will receive lenalidomide for 18 cycles, unless either rapid disease progression or unacceptable toxicity was observed.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free Survival (per IRC) |  | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free Survival (per Investigator) |  | 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 |  | From date of randomization Until date of death from any cause for up to 5 years | 
| Overall Response Rate (ORR) |  | 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 |  | 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 |  | 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 |  | up to the 1 month the last dose of last subject |