MIL62 Plus Lenalidomide for Patients With Relapsed/Refractory Indolent Non-Hodgkin's Lymphoma (FL and MZL)

Study Overview
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Brief Summary
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This phase 1b/2 trial studies the safety and best dose of lenalidomide when given together with MIL62 and how well this combination works in treating patients with Relapsed/Refractory low-grade Follicular Lymphoma(FL) and Marginal Zone Lymphoma(MZL). Giving MIL62 plus lenalidomide may work better in indolent Non-Hodgkin Lymphoma(NHL).

Detailed Description
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The Aim of this phase 1b/2 trial (MIL62 Plus Lenalidomide) is to find the safety and best dose of lenalidomide when given together with MIL62 and how well this combination works in treating patients with Relapsed/Refractory low-grade Follicular Lymphoma(FL) and Marginal Zone Lymphoma(MZL). Giving MIL62 plus lenalidomide may work better in indolent Non-Hodgkin Lymphoma(NHL).

Official Title
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A Multi-center, Open Label, Phase 1b/2 Study to Study the Efficacy and Safety of MIL62 Plus Lenalidomide in Subjects With Relapsed/Refractory Follicular Lymphoma or Marginal Zone Lymphoma

Conditions
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Follicular Lymphoma and Marginal Zone Lymphoma

Intervention / Treatment
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* Drug: Recombinant Humanized Monoclonal Antibody MIL62 Injection
* Drug: Lenalidomide


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 MZL or FL, WHO grade 1, 2 or 3a Evidence of progression or lack of response following at least 1 prior treatment 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 (unless abnormalities are related to NHL) Life expectancy >6 months Able and willing to provide written informed consent and to comply with the study protocol Exclusion Criteria: Evidence ongoing transformation into aggressive NHL 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MIL62 + Lenalidomide<br>MIL62 plus Lenalidomide | Drug: Recombinant Humanized Monoclonal Antibody MIL62 Injection<br>* 1000mg /dose for 12 cycles(28 days) and a total of 11 doses :the first Cycle(Day1,Day15), the 2nd-8th Cycles(Day 1 every cycle);the 9th-12nd Cycles (One dose every two cycles).<br>* Other names: MIL62;Drug: Lenalidomide<br>* Dose on days 2-22 every 28 days x 12 cycles: the starting dose is 10-mg ; Adjusted dose according to the tumor response or toxicity reaction<br>* Other names: Revlimid;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With an Objective Response of Complete Response | Percentage of Participants With an Objective Response of Complete Response | Baseline to 1 month after the last dose of last patient | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Kaplan-Meier Estimate of Duration of Response | Kaplan-Meier Estimate of Duration of Response | Baseline to 1 month after the last dose of last patient | 
| Percentage of Participants With Disease Control | Percentage of Participants With Disease Control | Baseline to 1 month after the last dose of last patient | 
| Participants With 1 Year Progression Free Survival | Participants With 1 Year Progression Free Survival | Baseline to 1 month after the last dose of last patient | 
| Number of Participants With Treatment Emergent Adverse Events | Number of Participants With Treatment Emergent Adverse Events | up to the 1 month the last dose of last subject | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CD20 ,Follicular Lymphoma,Marginal Zone Lymphoma,MIL62