Clinical Trials /

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

NCT04110301

Description:

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).

Related Conditions:
  • Follicular Lymphoma
  • Marginal Zone Lymphoma
Recruiting Status:

Not yet recruiting

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Title

  • Brief Title: MIL62 Plus Lenalidomide for Patients With Relapsed/Refractory Indolent Non-Hodgkin's Lymphoma (Follicular Lymphoma and Marginal Zone Lymphoma)
  • 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

Clinical Trial IDs

  • ORG STUDY ID: MIL62-CT02
  • NCT ID: NCT04110301

Conditions

  • Follicular Lymphoma and Marginal Zone Lymphoma

Interventions

DrugSynonymsArms
Recombinant Humanized Monoclonal Antibody MIL62 Injection, lenalinomideMIL62

Purpose

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).

Trial Arms

NameTypeDescriptionInterventions
MIL62Experimental
  • Recombinant Humanized Monoclonal Antibody MIL62 Injection, lenalinomide

Eligibility Criteria

        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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

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

Secondary Outcome Measures

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

Details

Phase:Phase 1/Phase 2
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:Beijing Mabworks Biotech Co., Ltd.

Trial Keywords

  • 1.CD20-positive 2.Follicular Lymphoma 3.Marginal Zone Lymphoma 4.MIL62

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