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

Follicular Lymphoma and Marginal Zone Lymphoma Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04834024
• Other study ID #: MIL62-CT301
• Status: Recruiting
• Phase: Phase 3
• Start date: June 2, 2021
• Est. completion date: March 2025

Study information

• Verified date: October 2023
• Source: Beijing Mabworks Biotech Co., Ltd.
• Contact: Yuankai Shi, doctor
• Phone: 8610-87788293
• Email: syuankaipumc[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 168
• Est. completion date: March 2025
• Est. primary completion date: March 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Follicular Lymphoma and Marginal Zone Lymphoma
• Lymphoma
• Lymphoma, B-Cell, Marginal Zone
• Lymphoma, Follicular

Intervention

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

Locations

Country	Name	City	State
China	Chinese Academy of Medical Sciences and Peking Union Medical College	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Mabworks Biotech Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free Survival (per IRC)		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	Progression-free Survival (per Investigator)		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	Overall Survival		From date of randomization Until date of death from any cause for up to 5 years
Secondary	Overall Response Rate (ORR)		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	Kaplan-Meier Estimate of Duration of Response		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	Percentage of Participants With Disease Control		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	Number of Participants With Treatment Emergent Adverse Events		up to the 1 month the last dose of last subject