Status:
RECRUITING
MIL62 Plus Lenalidomide for Patients With Relapsed/Refractory Indolent Non-Hodgkin's Lymphoma (FL and MZL)
Lead Sponsor:
Beijing Mabworks Biotech Co., Ltd.
Conditions:
Follicular Lymphoma and Marginal Zone Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
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 Follic...
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 w...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 28 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2025
Estimated Enrollment :
53 Patients enrolled
Trial Details
Trial ID
NCT04110301
Start Date
November 28 2019
End Date
May 1 2025
Last Update
November 20 2024
Active Locations (1)
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1
Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, China