MIL62 Plus Lenalidomide for Patients With Relapsed/Refractory Indolent Non-Hodgkin's Lymphoma (FL and MZL)
Recruiting now · Phase 1/Phase 2
Conditions studied: Follicular Lymphoma and Marginal Zone Lymphoma
In brief
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).
Key facts
- Study ID
- NCT04110301
- Run by
- Beijing Mabworks Biotech Co., Ltd.
- People needed
- 53
- Starts
- 2019-11-28
- Expected to finish
- 2025-05-01
- Last updated by the study team
- 2024-11-20
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Chinese Academy of Medical Sciences and Peking Union Medical College — Beijing, China (enrolling)
Full record on ClinicalTrials.gov
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