MIL62 Plus Lenalidomide for Patients With Relapsed/Refractory Indolent Non-Hodgkin's Lymphoma (FL and MZL)
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorBeijing Mabworks Biotech Co., Ltd.
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Recombinant Humanized Monoclonal Antibody MIL62 Injection
Drug1000mg /dose for 12 cycles(28 days) and a total of 11 doses :the first Cycle(Day1,Day15), the 2nd-8th Cycles(Day 1 every cycle);the 9th-12nd Cycles (One dose every two cycles).
Lenalidomide
DrugDose on days 2-22 every 28 days x 12 cycles: the starting dose is 10-mg ; Adjusted dose according to the tumor response or toxicity reaction
Treatment groups
53 Participants
are divided into 1 treatment groupGroup A: MIL62 + LenalidomideExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Percentage of Participants With an Objective Response of Complete Response
Percentage of Participants With an Objective Response of Complete Response
Time frame
Baseline to 1 month after the last dose of last patientSecondary outcomes
1
Kaplan-Meier Estimate of Duration of Response
Kaplan-Meier Estimate of Duration of Response
Time frame
Baseline to 1 month after the last dose of last patient2
Percentage of Participants With Disease Control
Percentage of Participants With Disease Control
Time frame
Baseline to 1 month after the last dose of last patient3
Participants With 1 Year Progression Free Survival
Participants With 1 Year Progression Free Survival
Time frame
Baseline to 1 month after the last dose of last patient4
Number of Participants With Treatment Emergent Adverse Events
Number of Participants With Treatment Emergent Adverse Events
Time frame
up to the 1 month the last dose of last subjectSponsors and contacts
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Source ClinicalTrials.gov