MIL62 Combined With Lenalidomide Versus Lenalidomide for Patients With Rituximab Refractory Follicular Lymphoma

NCT04834024 | Recruiting Phase 3

• 1 other identifier: MIL62-CT301
• Study Type: interventional
• Target: 168
• Locations: 1 country
• Sites: 1

Brief Summary

This phase III trial aims to compare the efficacy and safety of MIL62 combined lenalidomide and lenalidomide alone to treat patient diagnosed with Follicular Lymphoma (FL) and refractory to rituximab. The study randomized patients with a 1:1 ratio to receive either MIL62 plus lenalidomide or lenalidomide.

Conditions

Follicular Lymphoma and Marginal Zone Lymphoma

Outcome Measures

Primary Outcomes (1)

• Progression-free Survival (per IRC)

  From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years

Secondary Outcomes (6)

• Progression-free Survival (per Investigator)

  From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years

• Overall Survival

  From date of randomization Until date of death from any cause for up to 5 years

• Overall Response Rate (ORR)

  From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years

• Kaplan-Meier Estimate of Duration of Response

  From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years

• Percentage of Participants With Disease Control

  From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years

Study Arms (2)

Recombinant Humanized Monoclonal Antibody MIL62, lenalinomide

EXPERIMENTAL

Drug: Recombinant Humanized Monoclonal Antibody MIL62, lenalinomide

lenalinomide

ACTIVE COMPARATOR

Drug: lenalinomide

Interventions

Recombinant Humanized Monoclonal Antibody MIL62, lenalinomide DRUG

The patients confirming to the eligibility criteria will receive MIL62 from cycle 1 to cycle 30 and lenalidomide from cycle 1 to cycle 18, unless either rapid disease progression or unacceptable toxicity was observed.

Recombinant Humanized Monoclonal Antibody MIL62, lenalinomide

lenalinomide DRUG

The patients confirming to the eligibility criteria will receive lenalidomide for 18 cycles, unless either rapid disease progression or unacceptable toxicity was observed.

lenalinomide

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 FL, WHO grade 1, 2 or 3a
• Evidence of refractory to rituximab
• 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
• Life expectancy \>5 years
• Able and willing to provide written informed consent and to comply with the study protocol

You may not qualify if:

• Evidence of refractory to lenalinomide
• 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

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

Central Study Contacts

Yuankai Shi, doctor

CONTACT

8610-87788293; syuankaipumc@126.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2021
• First Posted: April 6, 2021
• Study Start: June 2, 2021
• Primary Completion: March 1, 2025
• Study Completion: March 1, 2025
• Last Updated: November 20, 2024

Record last verified: 2024-10

Locations

CN (1)