MIL62 with Lenalidomide for Follicular Lymphoma

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

Recruiting Phase 3 Interventional Study
Follicular Lymphoma and Marginal Zone Lymphoma
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
168 (estimated)
Sponsor
Beijing Mabworks Biotech Co., Ltd. · Industry
Who this trial is looking for

This trial is looking for adults with follicular lymphoma that has not responded to rituximab treatment. Participants will receive either MIL62 combined with lenalidomide or lenalidomide alone for their condition.

Are You a Good Fit for This Trial?
Rules you out Progressive multifocal leukoencephalopathyCentral nervous system lymphomaSevere allergic reactions to monoclonal antibodiesHIV infectionHepatitis B infectionHepatitis C infectionPregnancyLactation

You may be able to join if

  • I am at least 18 years old.
  • I have been diagnosed with follicular lymphoma.
  • I have not responded to rituximab.
  • I have a good performance status (ECOG 0, 1, or 2).
  • I have at least one measurable tumor that is larger than 1.5 cm.
  • I have adequate blood cell counts.
  • I expect to live for more than 5 years.
  • I can provide written consent and follow the study rules.

You may not be able to join if

  • I have not responded to lenalidomide.
  • I have central nervous system lymphoma.
  • I have had PML.
  • I have used any antibody therapy (except Rituximab) in the last 3 months.
  • I have had any anti-cancer vaccine before.
  • I have had radiotherapy in the last 42 days.
  • I have had chemotherapy in the last 28 days.
  • I have had another cancer in the last 3 years (except certain skin cancers).

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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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.

Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Adult patients, \>=18 years of age; 2. Patients with either histologically documented CD20-positive FL, WHO grade 1, 2 or 3a 3. Evidence of refractory to rituximab 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2 5. At least one bi-dimensionally me…
Contacts

Yuankai Shi, doctor

8610-87788293

syuankaipumc@126.com

CONTACT