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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04110301
Recruitment Status : Not yet recruiting
First Posted : October 1, 2019
Last Update Posted : October 7, 2019
Sponsor:
Information provided by (Responsible Party):
Beijing Mabworks Biotech Co., Ltd.

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).

Condition or disease Intervention/treatment Phase
Follicular Lymphoma and Marginal Zone Lymphoma Drug: Recombinant Humanized Monoclonal Antibody MIL62 Injection Drug: Lenalidomide Phase 1 Phase 2

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 53 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Estimated Study Start Date : October 2019
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : May 2023


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 Name: 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 Name: Revlimid




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04110301


Contacts
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Contact: Yuankai Shi, MD (+86)010-87788293 syuankaipumc@126.com

Sponsors and Collaborators
Beijing Mabworks Biotech Co., Ltd.
Investigators
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Principal Investigator: Yuankai Shi, MD Cancer Institute&Hospital, Chinese Academy of Medical Sciences,Beijing

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Responsible Party: Beijing Mabworks Biotech Co., Ltd.
ClinicalTrials.gov Identifier: NCT04110301    
Other Study ID Numbers: MIL62-CT02
First Posted: October 1, 2019    Key Record Dates
Last Update Posted: October 7, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Beijing Mabworks Biotech Co., Ltd.:
CD20 ,Follicular Lymphoma,Marginal Zone Lymphoma,MIL62
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, Follicular
Lymphoma, B-Cell, Marginal Zone
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Lymphoma, B-Cell
Lenalidomide
Antibodies
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents