Phase
Condition
Lymphoma
Marginal Zone Lymphoma
Lymphoma, B-cell
Treatment
Recombinant Humanized Monoclonal Antibody MIL62 Injection
Lenalidomide
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 scanas: 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 studyprotocol
Exclusion
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 studystart
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 ofcuratively treated basal or squamous cell carcinoma of the skin and low-grade insitu 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, unlessadministered for indications other than NHL at a dose equivalent to < 20 mg/dayprednisone
Any serious active disease or co-morbid medical condition (such as New York HeartAssociation Class II or IV cardiac disease, severe arrhythmia, myocardial infarctionwithin the last 6 months, unstable arrhythmias, or unstable angina) or pulmonarydisease (including obstructive pulmonary disease and history of bronchospasm orother according to investigator's decision)
Infection with human immunodeficiency virus (HIV), hepatitis B or hepatitisC(including HBsAg,HBcAb positive with abnormal HBV DAN or HCV RNA )
Pregnant or lactating females
Study Design
Study Description
Connect with a study center
Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing,
ChinaActive - Recruiting

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