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

NCT ID: NCT04834024

Last Updated: 2024-11-20

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 168 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-02
• Study Completion Date: 2025-03-31

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.

Conditions

Follicular Lymphoma and Marginal Zone Lymphoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Recombinant Humanized Monoclonal Antibody MIL62, lenalinomide

Group Type: EXPERIMENTAL

Recombinant Humanized Monoclonal Antibody MIL62, lenalinomide

Intervention Type: DRUG

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.

lenalinomide

Group Type: ACTIVE_COMPARATOR

lenalinomide

Intervention Type: DRUG

The patients confirming to the eligibility criteria will receive lenalidomide for 18 cycles, unless either rapid disease progression or unacceptable toxicity was observed.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing Mabworks Biotech Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Chinese Academy of Medical Sciences and Peking Union Medical College

Beijing, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Yuankai Shi, doctor

Role: CONTACT

syuankaipumc@126.com

8610-87788293

Facility Contacts

Yuankai Shi, doctor

Role: primary

References

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;73:102702. doi: 10.1016/j.eclinm.2024.102702. eCollection 2024 Jul.

Reference Type: DERIVED

PMID: 39007066 (View on PubMed)

Other Identifiers

MIL62-CT301

Identifier Type: -

Identifier Source: org_study_id