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

NCT04110301 | Recruiting Phase 1

• 1 other identifier: MIL62-CT02
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

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).

Conditions

Follicular Lymphoma and Marginal Zone Lymphoma

Keywords

CD20 ,Follicular Lymphoma,Marginal Zone Lymphoma,MIL62

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With an Objective Response of Complete Response

  Percentage of Participants With an Objective Response of Complete Response

  Baseline to 1 month after the last dose of last patient

Secondary Outcomes (4)

• Kaplan-Meier Estimate of Duration of Response

  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

  Baseline to 1 month after the last dose of last patient

• Number of Participants With Treatment Emergent Adverse Events

  up to the 1 month the last dose of last subject

Study Arms (1)

MIL62 + Lenalidomide

EXPERIMENTAL

MIL62 plus Lenalidomide

Drug: Recombinant Humanized Monoclonal Antibody MIL62 Injection; Drug: Lenalidomide

Interventions

Recombinant Humanized Monoclonal Antibody MIL62 Injection DRUG

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).

Also known as: MIL62

MIL62 + Lenalidomide

Lenalidomide DRUG

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

Also known as: Revlimid

MIL62 + Lenalidomide

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Beijing Mabworks Biotech Co., Ltd.: lead

Study Sites (1)

Chinese Academy of Medical Sciences and Peking Union Medical College

Beijing, China

RECRUITING

Related Publications (1)

• Shi Y, Zhou K, Zhou H, Qin Y, Jing H, Xiang Y, Wang Z, Wang Z, Zang A, Bai O, Li Z, Zhang H, Song Y, Liang J, Wei M. Efficacy and safety of MIL62, a novel glycoengineered type Ⅱ anti-CD20 monoclonal antibody, combined with lenalidomide in patients with relapsed/refractory follicular lymphoma or marginal zone lymphoma: a multicentre, single-arm, phase 1b/2 trial. EClinicalMedicine. 2024 Jun 20;73:102702. doi: 10.1016/j.eclinm.2024.102702. eCollection 2024 Jul.

  PMID: 39007066 DERIVED

MeSH Terms

Conditions

Lymphoma, Follicular; Lymphoma, B-Cell, Marginal Zone

Interventions

Lenalidomide

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Lymphoma, B-Cell

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Yuankai Shi, MD

  Cancer Institute&Hospital, Chinese Academy of Medical Sciences,Beijing

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yuankai Shi, MD

CONTACT

(+86)010-87788293; syuankaipumc@126.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2019
• First Posted: October 1, 2019
• Study Start: November 28, 2019
• Primary Completion: January 9, 2024
• Study Completion: May 1, 2025
• Last Updated: November 20, 2024

Record last verified: 2024-10

Locations

CN (1)