MIL62 Plus Lenalidomide for Patients With Relapsed/Refractory Indolent Non-Hodgkin's Lymphoma (FL and MZL)

Follicular Lymphoma and Marginal Zone Lymphoma Clinical Trial

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 Details — Status: Recruiting

Administrative data

• NCT number: NCT04110301
• Other study ID #: MIL62-CT02
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: November 28, 2019
• Est. completion date: May 2025

Study information

• Verified date: June 2023
• Source: Beijing Mabworks Biotech Co., Ltd.
• Contact: Yuankai Shi, MD
• Phone: (+86)010-87788293
• Email: syuankaipumc[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 53
• Est. completion date: May 2025
• Est. primary completion date: May 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Follicular Lymphoma and Marginal Zone Lymphoma
• Lymphoma
• Lymphoma, B-Cell, Marginal Zone
• Lymphoma, Follicular

Intervention

Drug:
• Recombinant Humanized Monoclonal Antibody MIL62 Injection
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).
• Lenalidomide
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

Locations

Country	Name	City	State
China	Chinese Academy of Medical Sciences and Peking Union Medical College	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Mabworks Biotech Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With an Objective Response of Complete Response	Percentage of Participants With an Objective Response of Complete Response	Baseline to 1 month after the last dose of last patient
Secondary	Kaplan-Meier Estimate of Duration of Response	Kaplan-Meier Estimate of Duration of Response	Baseline to 1 month after the last dose of last patient
Secondary	Percentage of Participants With Disease Control	Percentage of Participants With Disease Control	Baseline to 1 month after the last dose of last patient
Secondary	Participants With 1 Year Progression Free Survival	Participants With 1 Year Progression Free Survival	Baseline to 1 month after the last dose of last patient
Secondary	Number of Participants With Treatment Emergent Adverse Events	Number of Participants With Treatment Emergent Adverse Events	up to the 1 month the last dose of last subject