MIL62 Combined With Lenalidomide Versus Lenalidomide for Patients With Rituximab Refractory Follicular Lymphoma
Primary Purpose
Follicular Lymphoma and Marginal Zone Lymphoma
Status
Recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Recombinant Humanized Monoclonal Antibody MIL62, lenalinomide
lenalinomide
Sponsored by
About this trial
This is an interventional treatment trial for Follicular Lymphoma and Marginal Zone Lymphoma
Eligibility Criteria
Inclusion Criteria:
- Adult patients, >=18 years of age;
- Patients with either histologically documented CD20-positive FL, WHO grade 1, 2 or 3a
- Evidence of refractory to rituximab
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
- 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
- Adequate hematologic function
- Life expectancy >5 years
- Able and willing to provide written informed consent and to comply with the study protocol
Exclusion Criteria:
- Evidence of refractory to lenalinomide
- Central nervous system lymphoma
- Patients with progressive multifocalleukoencephalopathy (PML)
- Prior use of any antibody therapy(except for Rituximab ) within 3 months of study start
- Prior use of any anti-cancer vaccine
- Prior administration of radiotherapy 42 days prior to study entry
- Prior administration of chemotherapy 28 days prior to study entry
- 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
- History of severe allergic or anaphylactic reactions to monoclonal antibody therapy
- Known hypersensitivity to thalidomide or lenalidomide
- 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
- 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)
- Infection with human immunodeficiency virus (HIV), hepatitis B or hepatitis C(including HBsAg,HBcAb positive with abnormal HBV DAN or HCV RNA )
- Pregnant or lactating females
Sites / Locations
- Chinese Academy of Medical Sciences and Peking Union Medical CollegeRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Recombinant Humanized Monoclonal Antibody MIL62, lenalinomide
lenalinomide
Arm Description
Outcomes
Primary Outcome Measures
Progression-free Survival (per IRC)
Secondary Outcome Measures
Progression-free Survival (per Investigator)
Overall Survival
Overall Response Rate (ORR)
Kaplan-Meier Estimate of Duration of Response
Percentage of Participants With Disease Control
Number of Participants With Treatment Emergent Adverse Events
Full Information
NCT ID
NCT04834024
First Posted
April 5, 2021
Last Updated
October 19, 2023
Sponsor
Beijing Mabworks Biotech Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT04834024
Brief Title
MIL62 Combined With Lenalidomide Versus Lenalidomide for Patients With Rituximab Refractory Follicular Lymphoma
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 2, 2021 (Actual)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
March 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Beijing Mabworks Biotech Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Follicular Lymphoma and Marginal Zone Lymphoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
168 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Recombinant Humanized Monoclonal Antibody MIL62, lenalinomide
Arm Type
Experimental
Arm Title
lenalinomide
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Recombinant Humanized Monoclonal Antibody MIL62, lenalinomide
Intervention Description
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
Intervention Name(s)
lenalinomide
Intervention Description
The patients confirming to the eligibility criteria will receive lenalidomide for 18 cycles, unless either rapid disease progression or unacceptable toxicity was observed.
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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
Title
Overall Survival
Time Frame
From date of randomization Until date of death from any cause for up to 5 years
Title
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
Title
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
Title
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
Title
Number of Participants With Treatment Emergent Adverse Events
Time Frame
up to the 1 month the last dose of last subject
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult patients, >=18 years of age;
Patients with either histologically documented CD20-positive FL, WHO grade 1, 2 or 3a
Evidence of refractory to rituximab
Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
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
Adequate hematologic function
Life expectancy >5 years
Able and willing to provide written informed consent and to comply with the study protocol
Exclusion Criteria:
Evidence of refractory to lenalinomide
Central nervous system lymphoma
Patients with progressive multifocalleukoencephalopathy (PML)
Prior use of any antibody therapy(except for Rituximab ) within 3 months of study start
Prior use of any anti-cancer vaccine
Prior administration of radiotherapy 42 days prior to study entry
Prior administration of chemotherapy 28 days prior to study entry
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
History of severe allergic or anaphylactic reactions to monoclonal antibody therapy
Known hypersensitivity to thalidomide or lenalidomide
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
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)
Infection with human immunodeficiency virus (HIV), hepatitis B or hepatitis C(including HBsAg,HBcAb positive with abnormal HBV DAN or HCV RNA )
Pregnant or lactating females
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yuankai Shi, doctor
Phone
8610-87788293
Email
syuankaipumc@126.com
Facility Information:
Facility Name
Chinese Academy of Medical Sciences and Peking Union Medical College
City
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yuankai Shi, doctor
12. IPD Sharing Statement
Learn more about this trial
MIL62 Combined With Lenalidomide Versus Lenalidomide for Patients With Rituximab Refractory Follicular Lymphoma
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