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

Official title

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

Overview

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.

Interventions

• Drug Recombinant Humanized Monoclonal Antibody MIL62, lenalinomide
  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.
• Drug lenalinomide
  The patients confirming to the eligibility criteria will receive lenalidomide for 18 cycles, unless either rapid disease progression or unacceptable toxicity was observed.

Primary outcome measures

• Progression-free Survival (per IRC) [Time frame: 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 (6)

• Progression-free Survival (per Investigator) [Time frame: 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 [Time frame: From date of randomization Until date of death from any cause for up to 5 years]
• Overall Response Rate (ORR) [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: up to the 1 month the last dose of last subject]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

China · 1 center

• Chinese Academy of Medical Sciences and Peking Union Medical College — Beijing

Publications

• Shi Y, Zhou K, Zhou H, Qin Y, Jing H, Xiang Y, Wang Z, Wang Z, Zang A, Bai O, Li Z, Zhang H, Song Y, Liang J, Wei M. Efficacy and safety of MIL62, a novel glycoengineered type Ⅱ anti-CD20 monoclonal antibody, combined with lenalidomide in patients with relapsed/refractory follicular lymphoma or marginal zone lymphoma: a multicentre, single-arm, phase 1b/2 trial. EClinicalMedicine. 2024 Jun 20;73:1 PMID 39007066

Identifiers

NCT: NCT04834024 · MIL62-CT301

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗