Actively Recruiting
MIL62 Combined With Lenalidomide Versus Lenalidomide for Patients With Rituximab Refractory Follicular Lymphoma
Led by Beijing Mabworks Biotech Co., Ltd. · Updated on 2024-11-20
168
Participants Needed
1
Research Sites
195 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This phase III trial aims to compare the efficacy and safety of MIL62 combined lenalidomide and lenalidomide alone to treat patient diagnosed with Follicular Lymphoma (FL) and refractory to rituximab. The study randomized patients with a 1:1 ratio to receive either MIL62 plus lenalidomide or lenalidomide.
CONDITIONS
Official Title
MIL62 Combined With Lenalidomide Versus Lenalidomide for Patients With Rituximab Refractory Follicular Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult patients, 18 years of age or older
- Histologically confirmed CD20-positive Follicular Lymphoma, WHO grade 1, 2, or 3a
- Evidence of refractory disease to rituximab
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
- At least one measurable nodal or tumor lesion with greatest transverse diameter greater than 1.5 cm and short axis at least 10 mm by CT scan
- Adequate hematologic function
- Life expectancy greater than 5 years
- Able and willing to provide written informed consent and comply with the study protocol
You will not qualify if you...
- Evidence of refractory disease to lenalidomide
- Central nervous system lymphoma
- Progressive multifocal leukoencephalopathy (PML)
- Prior antibody therapy except rituximab within 3 months before study start
- Prior anti-cancer vaccine use
- Radiotherapy within 42 days prior to study entry
- Chemotherapy within 28 days prior to study entry
- History of prior malignancy within 3 years except treated basal or squamous cell carcinoma of skin and low-grade cervical carcinoma in situ
- History of severe allergic or anaphylactic reactions to monoclonal antibody therapy
- Known hypersensitivity to thalidomide or lenalidomide
- Regular corticosteroid treatment prior to cycle 1 unless for non-NHL indications at less than 20 mg/day prednisone equivalent
- Serious active diseases or co-morbid conditions including significant cardiac or pulmonary diseases
- Infection with HIV, hepatitis B, or hepatitis C
- Pregnant or lactating 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, doctor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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