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

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

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

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Estimated)

53

Phase

  • Phase 2
  • Phase 1

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 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

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MIL62 + Lenalidomide
MIL62 plus Lenalidomide
Drug: Recombinant Humanized Monoclonal Antibody MIL62 Injection
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).
Other Names:
  • MIL62
Drug: Lenalidomide
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
Other Names:
  • Revlimid

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With an Objective Response of Complete Response
Time Frame: Baseline to 1 month after the last dose of last patient
Percentage of Participants With an Objective Response of Complete Response
Baseline to 1 month after the last dose of last patient

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Kaplan-Meier Estimate of Duration of Response
Time Frame: Baseline to 1 month after the last dose of last patient
Kaplan-Meier Estimate of Duration of Response
Baseline to 1 month after the last dose of last patient
Percentage of Participants With Disease Control
Time Frame: Baseline to 1 month after the last dose of last patient
Percentage of Participants With Disease Control
Baseline to 1 month after the last dose of last patient
Participants With 1 Year Progression Free Survival
Time Frame: Baseline to 1 month after the last dose of last patient
Participants With 1 Year Progression Free Survival
Baseline to 1 month after the last dose of last patient
Number of Participants With Treatment Emergent Adverse Events
Time Frame: up to the 1 month the last dose of last subject
Number of Participants With Treatment Emergent Adverse Events
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.

Investigators

  • Principal Investigator: Yuankai Shi, MD, Cancer Institute&Hospital, Chinese Academy of Medical Sciences,Beijing

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)

November 28, 2019

Primary Completion (Estimated)

May 1, 2024

Study Completion (Estimated)

May 1, 2025

Study Registration Dates

First Submitted

September 27, 2019

First Submitted That Met QC Criteria

September 27, 2019

First Posted (Actual)

October 1, 2019

Study Record Updates

Last Update Posted (Actual)

October 23, 2023

Last Update Submitted That Met QC Criteria

October 19, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MIL62-CT02

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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