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

October 19, 2023 updated by: Beijing Mabworks Biotech Co., Ltd.

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 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

168

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Beijing, China
        • Recruiting
        • Chinese Academy of Medical Sciences and Peking Union Medical College
        • Contact:
          • Yuankai Shi, doctor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
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

Outcome Measure
Time Frame
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
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
Overall Survival
Time Frame: From date of randomization Until date of death from any cause for up to 5 years
From date of randomization Until date of death from any cause for up to 5 years
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
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
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
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
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
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
Number of Participants With Treatment Emergent Adverse Events
Time Frame: up to the 1 month the last dose of last subject
up to the 1 month the last dose of last subject

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Mabworks Biotech Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 2, 2021

Primary Completion (Estimated)

March 1, 2024

Study Completion (Estimated)

March 1, 2025

Study Registration Dates

First Submitted

April 5, 2021

First Submitted That Met QC Criteria

April 5, 2021

First Posted (Actual)

April 6, 2021

Study Record Updates

Last Update Posted (Actual)

October 23, 2023

Last Update Submitted That Met QC Criteria

October 19, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MIL62-CT301

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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