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

  • STATUS
    Recruiting
  • End date
    Mar 24, 2025
  • participants needed
    168
  • sponsor
    Beijing Mabworks Biotech Co., Ltd.
Updated on 24 March 2022

Summary

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.

Details
Condition Follicular Lymphoma and Marginal Zone Lymphoma
Treatment Recombinant Humanized Monoclonal Antibody MIL62, lenalinomide, lenalinomide
Clinical Study IdentifierNCT04834024
SponsorBeijing Mabworks Biotech Co., Ltd.
Last Modified on24 March 2022

Eligibility

Yes No Not Sure

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
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