Clinical trial · Interventional
MIL62 Combined With Lenalidomide Versus Lenalidomide for Patients With Rituximab Refractory 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
NCT04834024CI-TRIAL-00082779recruitingPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Follicular Lymphoma and Marginal Zone Lymphoma | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| lenalinomide | Drug | — | UNRESOLVED |
| Recombinant Humanized Monoclonal Antibody MIL62, lenalinomide | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Recombinant Humanized Monoclonal Antibody MIL62, lenalinomide
- interventionNames
- Drug: Recombinant Humanized Monoclonal Antibody MIL62, lenalinomide
- type
- ACTIVE_COMPARATOR
- label
- lenalinomide
- interventionNames
- Drug: lenalinomide
Primary outcomes (1)
- measure
- Progression-free Survival (per IRC)
- timeFrame
- 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 outcomes (6)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDShi 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;73:102702. doi: 10.1016/j.eclinm.2024.102702. eCollection 2024 Jul. PMID 39007066