MIL62 Combined With Lenalidomide Versus Lenalidomide for Patients With Rituximab Refractory Follicular Lymphoma
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorBeijing Mabworks Biotech Co., Ltd.
About this trial
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.
Eligibility criteria
Qualifiers
Adult patients, >=18 years of age;
Patients with either histologically documented CD20-positive FL, WHO grade 1, 2 or 3a
Evidence of refractory to rituximab
Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
Disqualifiers
Evidence of refractory to lenalinomide
Central nervous system lymphoma
Patients with progressive multifocalleukoencephalopathy (PML)
Prior use of any antibody therapy(except for Rituximab ) within 3 months of study start
Trial design
Treatments tested in this trial
- Recombinant Humanized Monoclonal Antibody MIL62, lenalinomide
- lenalinomide
Treatment groups
168 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov