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MIL62 Plus Lenalidomide for Patients With Relapsed/Refractory Indolent Non-Hodgkin's Lymphoma (FL and MZL)

Primary Purpose

Follicular Lymphoma and Marginal Zone Lymphoma

Status
Recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Recombinant Humanized Monoclonal Antibody MIL62 Injection
Lenalidomide
Sponsored by
Beijing Mabworks Biotech Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Follicular Lymphoma and Marginal Zone Lymphoma focused on measuring CD20 ,Follicular Lymphoma,Marginal Zone Lymphoma,MIL62

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Adult patients, >=18 years of age;
  2. Patients with either histologically documented CD20-positive MZL or FL, WHO grade 1, 2 or 3a
  3. Evidence of progression or lack of response following at least 1 prior treatment
  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 (unless abnormalities are related to NHL)
  7. Life expectancy >6 months
  8. Able and willing to provide written informed consent and to comply with the study protocol

Exclusion Criteria:

  1. Evidence ongoing transformation into aggressive NHL
  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

Sites / Locations

  • Chinese Academy of Medical Sciences and Peking Union Medical CollegeRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

MIL62 + Lenalidomide

Arm Description

MIL62 plus Lenalidomide

Outcomes

Primary Outcome Measures

Percentage of Participants With an Objective Response of Complete Response
Percentage of Participants With an Objective Response of Complete Response

Secondary Outcome Measures

Kaplan-Meier Estimate of Duration of Response
Kaplan-Meier Estimate of Duration of Response
Percentage of Participants With Disease Control
Percentage of Participants With Disease Control
Participants With 1 Year Progression Free Survival
Participants With 1 Year Progression Free Survival
Number of Participants With Treatment Emergent Adverse Events
Number of Participants With Treatment Emergent Adverse Events

Full Information

First Posted
September 27, 2019
Last Updated
October 19, 2023
Sponsor
Beijing Mabworks Biotech Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT04110301
Brief Title
MIL62 Plus Lenalidomide for Patients With Relapsed/Refractory Indolent Non-Hodgkin's Lymphoma (FL and MZL)
Official Title
A Multi-center, Open Label, Phase 1b/2 Study to Study the Efficacy and Safety of MIL62 Plus Lenalidomide in Subjects With Relapsed/Refractory Follicular Lymphoma or Marginal Zone Lymphoma
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 28, 2019 (Actual)
Primary Completion Date
May 2024 (Anticipated)
Study Completion Date
May 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 1b/2 trial studies the safety and best dose of lenalidomide when given together with MIL62 and how well this combination works in treating patients with Relapsed/Refractory low-grade Follicular Lymphoma(FL) and Marginal Zone Lymphoma(MZL). Giving MIL62 plus lenalidomide may work better in indolent Non-Hodgkin Lymphoma(NHL).
Detailed Description
The Aim of this phase 1b/2 trial (MIL62 Plus Lenalidomide) is to find the safety and best dose of lenalidomide when given together with MIL62 and how well this combination works in treating patients with Relapsed/Refractory low-grade Follicular Lymphoma(FL) and Marginal Zone Lymphoma(MZL). Giving MIL62 plus lenalidomide may work better in indolent Non-Hodgkin Lymphoma(NHL).

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
Keywords
CD20 ,Follicular Lymphoma,Marginal Zone Lymphoma,MIL62

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
53 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
MIL62 + Lenalidomide
Arm Type
Experimental
Arm Description
MIL62 plus Lenalidomide
Intervention Type
Drug
Intervention Name(s)
Recombinant Humanized Monoclonal Antibody MIL62 Injection
Other Intervention Name(s)
MIL62
Intervention Description
1000mg /dose for 12 cycles(28 days) and a total of 11 doses :the first Cycle(Day1,Day15), the 2nd-8th Cycles(Day 1 every cycle);the 9th-12nd Cycles (One dose every two cycles).
Intervention Type
Drug
Intervention Name(s)
Lenalidomide
Other Intervention Name(s)
Revlimid
Intervention Description
Dose on days 2-22 every 28 days x 12 cycles: the starting dose is 10-mg ; Adjusted dose according to the tumor response or toxicity reaction
Primary Outcome Measure Information:
Title
Percentage of Participants With an Objective Response of Complete Response
Description
Percentage of Participants With an Objective Response of Complete Response
Time Frame
Baseline to 1 month after the last dose of last patient
Secondary Outcome Measure Information:
Title
Kaplan-Meier Estimate of Duration of Response
Description
Kaplan-Meier Estimate of Duration of Response
Time Frame
Baseline to 1 month after the last dose of last patient
Title
Percentage of Participants With Disease Control
Description
Percentage of Participants With Disease Control
Time Frame
Baseline to 1 month after the last dose of last patient
Title
Participants With 1 Year Progression Free Survival
Description
Participants With 1 Year Progression Free Survival
Time Frame
Baseline to 1 month after the last dose of last patient
Title
Number of Participants With Treatment Emergent Adverse Events
Description
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 MZL or FL, WHO grade 1, 2 or 3a Evidence of progression or lack of response following at least 1 prior treatment 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 (unless abnormalities are related to NHL) Life expectancy >6 months Able and willing to provide written informed consent and to comply with the study protocol Exclusion Criteria: Evidence ongoing transformation into aggressive NHL 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, MD
Phone
(+86)010-87788293
Email
syuankaipumc@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yuankai Shi, MD
Organizational Affiliation
Cancer Institute&Hospital, Chinese Academy of Medical Sciences,Beijing
Official's Role
Principal Investigator
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 Plus Lenalidomide for Patients With Relapsed/Refractory Indolent Non-Hodgkin's Lymphoma (FL and MZL)

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