Comparing MIL62 with Lenalidomide to Lenalidomide Alone for Follicular Lymphoma

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

This study is testing if adding a new treatment called MIL62 to the standard drug lenalidomide can help people with follicular lymphoma who haven't responded to other treatments.

Quick facts

• Phase: PHASE3
• Study type: Interventional
• Enrollment: 168 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Beijing Mabworks Biotech Co., Ltd. (industry)
• Drugs / interventions: rituximab, chemotherapy, prednisone
• Locations: 1 site (Beijing)
• Trial ID: NCT04834024 on ClinicalTrials.gov

What this trial studies

This phase III trial evaluates the effectiveness and safety of combining MIL62, a recombinant humanized monoclonal antibody, with lenalidomide compared to lenalidomide alone in treating patients with rituximab-refractory follicular lymphoma. Patients will be randomized in a 1:1 ratio to receive either the combination therapy or lenalidomide alone. The study aims to determine if the addition of MIL62 improves treatment outcomes for this patient population.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with histologically confirmed CD20-positive follicular lymphoma who are refractory to rituximab.

Not a fit: Patients who have shown resistance to lenalidomide or have central nervous system lymphoma may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a more effective option for patients with rituximab-refractory follicular lymphoma.

How similar studies have performed: Other studies have explored similar combination therapies, but the specific combination of MIL62 and lenalidomide is novel.

Eligibility criteria

Inclusion Criteria:

1. Adult patients, \>=18 years of age;
2. Patients with either histologically documented CD20-positive FL, WHO grade 1, 2 or 3a
3. Evidence of refractory to rituximab
4. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
5. 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
6. Adequate hematologic function
7. Life expectancy \>5 years
8. Able and willing to provide written informed consent and to comply with the study protocol

Exclusion Criteria:

1. Evidence of refractory to lenalinomide
2. Central nervous system lymphoma
3. Patients with progressive multifocalleukoencephalopathy (PML)
4. Prior use of any antibody therapy(except for Rituximab ) within 3 months of study start
5. Prior use of any anti-cancer vaccine
6. Prior administration of radiotherapy 42 days prior to study entry
7. Prior administration of chemotherapy 28 days prior to study entry
8. 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
9. History of severe allergic or anaphylactic reactions to monoclonal antibody therapy
10. Known hypersensitivity to thalidomide or lenalidomide
11. 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
12. 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)
13. Infection with human immunodeficiency virus (HIV), hepatitis B or hepatitis C(including HBsAg,HBcAb positive with abnormal HBV DAN or HCV RNA )
14. Pregnant or lactating females

Where this trial is running

Beijing

• Chinese Academy of Medical Sciences and Peking Union Medical College — Beijing, China (RECRUITING)

Study contacts

• Study coordinator: Yuankai Shi, doctor

Conditions: Follicular Lymphoma and Marginal Zone Lymphoma