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MIL62 Combined With Lenalidomide Versus Lenalidomide for Patients With Rituximab Refractory Follicular Lymphoma

ConditionFollicular Lymphoma and Marginal Zone 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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Recombinant Humanized Monoclonal Antibody MIL62, lenalinomide

    Drug

    The patients confirming to the eligibility criteria will receive MIL62 from cycle 1 to cycle 30 and lenalidomide from cycle 1 to cycle 18, unless either rapid disease progression or unacceptable toxicity was observed.

  • lenalinomide

    Drug

    The patients confirming to the eligibility criteria will receive lenalidomide for 18 cycles, unless either rapid disease progression or unacceptable toxicity was observed.

Treatment groups

168 Participants
are divided into 2 treatment groups
Group A: Recombinant Humanized Monoclonal Antibody MIL62, lenalinomideExperimental treatment 1 intervention
Group B: lenalinomideActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Progression-free Survival (per IRC)

Time frame
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years

Secondary outcomes

1

Progression-free Survival (per Investigator)

Time frame
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years
2

Overall Survival

Time frame
From date of randomization Until date of death from any cause for up to 5 years
3

Overall Response Rate (ORR)

Time frame
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years
4

Kaplan-Meier Estimate of Duration of Response

Time frame
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Beijing Mabworks Biotech Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov
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