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

• ClinicalTrials.gov Identifier: NCT04834024
• Recruitment Status: Recruiting
• First Posted: April 6, 2021
• Last Update Posted: February 15, 2022
• Sponsor: Beijing Mabworks Biotech Co., Ltd.
• Information provided by (Responsible Party): Beijing Mabworks Biotech Co., Ltd.

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Follicular Lymphoma and Marginal Zone Lymphoma	Drug: Recombinant Humanized Monoclonal Antibody MIL62, lenalinomide; Drug: lenalinomide	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 168 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: June 2, 2021
• Estimated Primary Completion Date: March 2023
• Estimated Study Completion Date: March 2025

Arms and Interventions

Arm	Intervention/treatment
Experimental: Recombinant Humanized Monoclonal Antibody MIL62, lenalinomide	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.
Active Comparator: lenalinomide	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.

Outcome Measures

Primary Outcome Measures :

1. 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 :

1. 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 ]
2. Overall Survival [ Time Frame: From date of randomization Until date of death from any cause for up to 5 years ]
3. 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 ]
4. 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 ]
5. 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 ]
6. Number of Participants With Treatment Emergent Adverse Events [ Time Frame: up to the 1 month the last dose of last subject ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Contacts

Contact: Yuankai Shi, doctor; 8610-87788293; syuankaipumc@126.com

Locations

China

Chinese Academy of Medical Sciences and Peking Union Medical College; Recruiting

Beijing, China

Contact: Yuankai Shi, doctor

Sponsors and Collaborators

Beijing Mabworks Biotech Co., Ltd.

More Information

• Responsible Party: Beijing Mabworks Biotech Co., Ltd.
• ClinicalTrials.gov Identifier: NCT04834024
• Other Study ID Numbers: MIL62-CT301
• First Posted: April 6, 2021
• Last Update Posted: February 15, 2022
• Last Verified: September 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Lymphoma; Lymphoma, Follicular; Lymphoma, B-Cell, Marginal Zone; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Lymphoma, Non-Hodgkin; Lymphoma, B-Cell; Antibodies; Antibodies, Monoclonal; Immunologic Factors; Physiological Effects of Drugs