Clinical trial NCT04110301: MIL62 Plus Lenalidomide for Patients With Relapsed/Refractory Indolent Non-Hodgkin's Lymphoma (FL and MZL)
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Follicular Lymphoma and Marginal Zone Lymphoma
Keywords: CD20 ,Follicular Lymphoma,Marginal Zone Lymphoma,MIL62
Lead sponsor: Beijing Mabworks Biotech Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2019-10-01
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

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).

Eligibility 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

Primary outcomes:
measure: Percentage of Participants With an Objective Response of Complete Response
timeFrame: Baseline to 1 month after the last dose of last patient
Secondary outcomes:
measure: Kaplan-Meier Estimate of Duration of Response
timeFrame: Baseline to 1 month after the last dose of last patient
measure: Percentage of Participants With Disease Control
timeFrame: Baseline to 1 month after the last dose of last patient
measure: Participants With 1 Year Progression Free Survival
timeFrame: Baseline to 1 month after the last dose of last patient
measure: Number of Participants With Treatment Emergent Adverse Events
timeFrame: up to the 1 month the last dose of last subject
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese Academy of Medical Sciences and Peking Union Medical College
Study officials:
affiliation: Cancer Institute&Hospital, Chinese Academy of Medical Sciences,Beijing
name: Yuankai Shi, MD
role: PRINCIPAL_INVESTIGATOR
References: