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

Официальное название

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

Обзор

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).

Подробное описание

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).

Вмешательства

• Препарат 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).
• Препарат 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

Первичные конечные точки

• Percentage of Participants With an Objective Response of Complete Response [Срок оценки: Baseline to 1 month after the last dose of last patient]

Вторичные конечные точки (4)

• Kaplan-Meier Estimate of Duration of Response [Срок оценки: Baseline to 1 month after the last dose of last patient]
• Percentage of Participants With Disease Control [Срок оценки: Baseline to 1 month after the last dose of last patient]
• Participants With 1 Year Progression Free Survival [Срок оценки: Baseline to 1 month after the last dose of last patient]
• Number of Participants With Treatment Emergent Adverse Events [Срок оценки: up to the 1 month the last dose of last subject]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Chinese Academy of Medical Sciences and Peking Union Medical College — Пекин

Публикации

• 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;73:1 PMID 39007066

Идентификаторы

NCT: NCT04110301 · MIL62-CT02

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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