Actively Recruiting
MIL62 Plus Lenalidomide for Patients With Relapsed/Refractory Indolent Non-Hodgkin's Lymphoma (FL and MZL)
Led by Beijing Mabworks Biotech Co., Ltd. · Updated on 2024-11-20
53
Participants Needed
1
Research Sites
283 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
MIL62 Plus Lenalidomide for Patients With Relapsed/Refractory Indolent Non-Hodgkin's Lymphoma (FL and MZL)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult patients, 18 years of age or older
- Histologically confirmed CD20-positive Marginal Zone Lymphoma or Follicular Lymphoma, WHO grade 1, 2, or 3a
- Evidence of disease progression or lack of response after at least one prior treatment
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
- At least one measurable nodal or tumor lesion by CT scan with greatest diameter over 1.5 cm and short axis at least 10 mm
- Adequate blood cell counts unless related to lymphoma
- Life expectancy greater than 6 months
- Ability and willingness to provide written informed consent and follow the study protocol
You will not qualify if you...
- Ongoing transformation into aggressive Non-Hodgkin Lymphoma
- Central nervous system lymphoma
- Progressive multifocal leukoencephalopathy (PML)
- Use of any antibody therapy (except Rituximab) within 3 months before study start
- Prior use of any anti-cancer vaccine
- Radiotherapy within 42 days before study entry
- Chemotherapy within 28 days before study entry
- History of another cancer within the last 3 years, except treated basal or squamous cell skin cancer or low-grade cervical carcinoma in situ
- Severe allergic reactions to monoclonal antibody therapy
- Known allergy to thalidomide or lenalidomide
- Regular corticosteroid treatment before cycle 1 unless for non-lymphoma reasons at less than 20 mg/day prednisone equivalent
- Serious active diseases or medical conditions such as specific heart or lung diseases
- Infection with HIV, hepatitis B or C
- Pregnant or breastfeeding females
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, China
Actively Recruiting
Research Team
Y
Yuankai Shi, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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