Description:
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).
Title
- Brief Title: MIL62 Plus Lenalidomide for Patients With Relapsed/Refractory Indolent Non-Hodgkin's Lymphoma (FL and MZL)
- Official Title: 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
Clinical Trial IDs
- ORG STUDY ID:
MIL62-CT02
- NCT ID:
NCT04110301
Conditions
- Follicular Lymphoma and Marginal Zone Lymphoma
Interventions
Drug | Synonyms | Arms |
---|
Recombinant Humanized Monoclonal Antibody MIL62 Injection | MIL62 | MIL62 + Lenalidomide |
Lenalidomide | Revlimid | MIL62 + Lenalidomide |
Purpose
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).
Trial Arms
Name | Type | Description | Interventions |
---|
MIL62 + Lenalidomide | Experimental | MIL62 plus Lenalidomide | - Recombinant Humanized Monoclonal Antibody MIL62 Injection
- Lenalidomide
|
Eligibility 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
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Percentage of Participants With an Objective Response of Complete Response |
Time Frame: | Baseline to 1 month after the last dose of last patient |
Safety Issue: | |
Description: | Percentage of Participants With an Objective Response of Complete Response |
Secondary Outcome Measures
Measure: | Kaplan-Meier Estimate of Duration of Response |
Time Frame: | Baseline to 1 month after the last dose of last patient |
Safety Issue: | |
Description: | Kaplan-Meier Estimate of Duration of Response |
Measure: | Percentage of Participants With Disease Control |
Time Frame: | Baseline to 1 month after the last dose of last patient |
Safety Issue: | |
Description: | Percentage of Participants With Disease Control |
Measure: | Participants With 1 Year Progression Free Survival |
Time Frame: | Baseline to 1 month after the last dose of last patient |
Safety Issue: | |
Description: | Participants With 1 Year Progression Free Survival |
Measure: | Number of Participants With Treatment Emergent Adverse Events |
Time Frame: | up to the 1 month the last dose of last subject |
Safety Issue: | |
Description: | Number of Participants With Treatment Emergent Adverse Events |
Details
Phase: | Phase 1/Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Beijing Mabworks Biotech Co., Ltd. |
Trial Keywords
- CD20 ,Follicular Lymphoma,Marginal Zone Lymphoma,MIL62
Last Updated
June 18, 2021