MIL62 Plus Lenalidomide for Patients With Relapsed/Refractory Indolent Non-Hodgkin's Lymphoma (FL and MZL)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Recombinant Humanized Monoclonal Antibody MIL62 Injection, Lenalidomide.
- Who it may be relevant to
- Registry conditions: Follicular Lymphoma and Marginal Zone Lymphoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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).
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).
Interventions
- 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). - 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
Primary outcome measures
- Percentage of Participants With an Objective Response of Complete Response [Time frame: Baseline to 1 month after the last dose of last patient]
Secondary outcome measures (4)
- Kaplan-Meier Estimate of Duration of Response [Time frame: Baseline to 1 month after the last dose of last patient]
- Percentage of Participants With Disease Control [Time frame: Baseline to 1 month after the last dose of last patient]
- Participants With 1 Year Progression Free Survival [Time frame: Baseline to 1 month after the last dose of last patient]
- Number of Participants With Treatment Emergent Adverse Events [Time frame: up to the 1 month the last dose of last subject]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Chinese Academy of Medical Sciences and Peking Union Medical College — Beijing
Publications
- 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
Identifiers
NCT: NCT04110301 · MIL62-CT02