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Compares treatment options for Follicular Lymphoma and Marginal Zone Lymphoma
Official title MIL62 Combined With Lenalidomide Versus Lenalidomide for Patients With Rituximab Refractory Follicular Lymphoma
ClinicalTrials.gov ID: NCT04834024
What this study is testing
What is Recombinant Humanized Monoclonal Antibody MIL62, lenalinomide?
Recombinant Humanized Monoclonal Antibody MIL62, lenalinomide is an investigational medicine, being studied as a potential treatment for follicular lymphoma and marginal zone lymphoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
- 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
You likely can't join if
- 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
- Prior use of any anti-cancer vaccine
- Prior administration of radiotherapy 42 days prior to study entry
See the full eligibility criteria
- 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
- 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
- Adequate hematologic function
- Life expectancy \>5 years
- Able and willing to provide written informed consent and to comply with the study protocol
- 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
- Prior use of any anti-cancer vaccine
- Prior administration of radiotherapy 42 days prior to study entry
- Prior administration of chemotherapy 28 days prior to study entry
- 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
- History of severe allergic or anaphylactic reactions to monoclonal antibody therapy
- Known hypersensitivity to thalidomide or lenalidomide
- 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
- 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...
- Infection with human immunodeficiency virus (HIV), hepatitis B or hepatitis C(including HBsAg,HBcAb positive with abnormal HBV DAN or HCV RNA )
- Pregnant or lactating females
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.