MIL62 Combined With Lenalidomide Versus Lenalidomide for Patients With Rituximab Refractory Follicular Lymphoma
Recruiting
Phase 3Interventional 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 outProgressive 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.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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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City
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Status
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…
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 measurable nodal or tumor lesion defined by CT scan as: greatest transverse diameter \> 1.5 cm and a short axis ≥ 10mm
6. Adequate hematologic function
7. Life expectancy \>5 years
8. Able and willing to provide written informed consent and to comply with the study protocol
Exclusion Criteria:
1. Evidence of refractory to lenalinomide
2. Central nervous system lymphoma
3. Patients with progressive multifocalleukoencephalopathy (PML)
4. Prior use of any antibody therapy(except for Rituximab ) within 3 months of study start
5. Prior use of any anti-cancer vaccine
6. Prior administration of radiotherapy 42 days prior to study entry
7. Prior administration of chemotherapy 28 days prior to study entry
8. History of prior malignancy within the last 3 years, with the exception of curatively treated basal or squamous cell carcinoma of the skin and low-grade in situ carcinoma of the cervix
9. History of severe allergic or anaphylactic reactions to monoclonal antibody therapy
10. Known hypersensitivity to thalidomide or lenalidomide
11. Regular treatment with corticosteroids prior to the start of cycle 1, unless administered for indications other than NHL at a dose equivalent to \< 20 mg/day prednisone
12. Any serious active disease or co-morbid medical condition (such as New York Heart Association Class II or IV cardiac disease, severe arrhythmia, myocardial infarction within the last 6 months, unstable arrhythmias, or unstable angina) or pulmonary disease (including obstructive pulmonary disease and history of bronchospasm or other according to investigator's decision)
13. Infection with human immunodeficiency virus (HIV), hepatitis B or hepatitis C(including HBsAg,HBcAb positive with abnormal HBV DAN or HCV RNA )
14. Pregnant or lactating females
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