Follicular Lymphoma and Marginal Zone Lymphoma
Conditions
Keywords
CD20 ,Follicular Lymphoma,Marginal Zone Lymphoma,MIL62
Brief summary
This phase 1b/2 trial studies the safety and best dose of lenalidomide when given together with MIL62 and how well this combination works in treating patients with Relapsed/Refractory low-grade Follicular Lymphoma(FL) and Marginal Zone Lymphoma(MZL). Giving MIL62 plus lenalidomide may work better in indolent Non-Hodgkin Lymphoma(NHL).
Detailed description
The Aim of this phase 1b/2 trial (MIL62 Plus Lenalidomide) is to find the safety and best dose of lenalidomide when given together with MIL62 and how well this combination works in treating patients with Relapsed/Refractory low-grade Follicular Lymphoma(FL) and Marginal Zone Lymphoma(MZL). Giving MIL62 plus lenalidomide may work better in indolent Non-Hodgkin Lymphoma(NHL).
Interventions
1000mg /dose for 12 cycles(28 days) and a total of 11 doses :the first Cycle(Day1,Day15), the 2nd-8th Cycles(Day 1 every cycle);the 9th-12nd Cycles (One dose every two cycles).
DRUGLenalidomide
Dose on days 2-22 every 28 days x 12 cycles: the starting dose is 10-mg ; Adjusted dose according to the tumor response or toxicity reaction
Sponsors
Beijing Mabworks Biotech Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With an Objective Response of Complete Response | Baseline to 1 month after the last dose of last patient | Percentage of Participants With an Objective Response of Complete Response |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Kaplan-Meier Estimate of Duration of Response | Baseline to 1 month after the last dose of last patient | Kaplan-Meier Estimate of Duration of Response |
| Percentage of Participants With Disease Control | Baseline to 1 month after the last dose of last patient | Percentage of Participants With Disease Control |
| Participants With 1 Year Progression Free Survival | Baseline to 1 month after the last dose of last patient | Participants With 1 Year Progression Free Survival |
| Number of Participants With Treatment Emergent Adverse Events | up to the 1 month the last dose of last subject | Number of Participants With Treatment Emergent Adverse Events |
Countries
China
Contacts
Primary ContactYuankai Shi, MD
Outcome results
None listed