Combination of MIL62 and Lenalidomide for treating certain types of Non-Hodgkin's Lymphoma
A Multi-center, Open Label, Phase 1b/2 Study to Study the Efficacy and Safety of MIL62 Plus Lenalidomide in Subjects With Relapsed/Refractory Follicular Lymphoma or Marginal Zone Lymphoma
This study is testing if a new combination of two medications, MIL62 and lenalidomide, can help people with certain types of Non-Hodgkin's Lymphoma feel better.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 53 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Beijing Mabworks Biotech Co., Ltd. Industry-sponsored |
| Drugs / interventions | Rituximab, chemotherapy, prednisone |
| Locations | 1 site (Beijing) |
| Trial ID | NCT04110301 on ClinicalTrials.gov |
What this trial studies
This trial investigates the safety and optimal dosage of lenalidomide when combined with MIL62 in patients suffering from relapsed or refractory low-grade Follicular Lymphoma (FL) and Marginal Zone Lymphoma (MZL). The study aims to determine how effectively this combination can treat these indolent forms of Non-Hodgkin Lymphoma. Participants will undergo treatment and be monitored for responses and side effects to assess the efficacy of the combination therapy.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with histologically confirmed CD20-positive MZL or FL who have experienced disease progression after at least one prior treatment.
Not a fit: Patients with aggressive forms of Non-Hodgkin Lymphoma or those with central nervous system lymphoma may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new effective option for patients with relapsed or refractory indolent Non-Hodgkin's Lymphoma.
How similar studies have performed: While this approach is novel in combining MIL62 with lenalidomide, similar studies have shown promise in treating indolent Non-Hodgkin Lymphoma with other therapies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Adult patients, \>=18 years of age; 2. Patients with either histologically documented CD20-positive MZL or FL, WHO grade 1, 2 or 3a 3. Evidence of progression or lack of response following at least 1 prior treatment 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 (unless abnormalities are related to NHL) 7. Life expectancy \>6 months 8. Able and willing to provide written informed consent and to comply with the study protocol Exclusion Criteria: 1. Evidence ongoing transformation into aggressive NHL 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
Where this trial is running
Beijing
- Chinese Academy of Medical Sciences and Peking Union Medical College — Beijing, China (Recruiting)
Study contacts
- Principal investigator: Yuankai Shi, MD — Cancer Institute&Hospital, Chinese Academy of Medical Sciences,Beijing
- Study coordinator: Yuankai Shi, MD
- Email: syuankaipumc@126.com
- Phone: (+86)010-87788293
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.