Evaluate the Efficacy and Safety of HLX01 Versus Mabthera in Patients With Low Tumour Burden Follicular Lymphoma.

Launched by SHANGHAI HENLIUS BIOTECH · Dec 10, 2020

Keywords

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Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Voluntary written informed consent before any study-related activities
• • 2. ≥ 18 years of age
• • 3. Histologically-confirmed, stage II to IV NHL (CD20+ FL of grades 1, 2, or 3a) by World Health Organization classification of lymphoid neoplasms (2016 revision) \[11\]
• • 4. Low tumour burden according to the GELF criteria
• • 5. The Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
• • 6. Availability of tumour sample within 12 months before start of study drug treatment
• • 7. At least 1 bi-dimensionally measurable nodal lesion \>1.5 cm or extranodal lesion \>1 cm in its longest diameter by CT scan as defined by the Modified Lugano Response Classification 2014
• • 8. Adequate organ function
• Exclusion Criteria:
• • 1. Prior treatment for FL. Patients previously treated with radiotherapy for stage I FL may be eligible provided they have a measurable lesion located outside the radiation field
• • 2. Transformation to high-grade lymphoma
• • 3. Patients with advanced disease that are considered for treatment with combined chemo immunotherapy
• • 4. Presence or history of central nervous system (CNS) lymphoma involvement
• • 5. Treatment with an investigational agent within 28 days of the first dose of study drug infusion
• • 6. Prior treatment with a chimeric antibody, including HLX01 and Mabthera®
• • 7. History of another malignancy within 2 years of screening, with the exception of curatively treated non-melanoma skin cancer, carcinoma in situ of the uterine cervix, breast or bladder, localised prostate cancer stage T1c or less - and provided that the patient remains relapse free
• • 8. Major surgery within 28 days of the first dose of study drug infusion (excluding lymph node biopsy)
• • 9. Known human immunodeficiency virus (HIV) infection (Serological test for HIV should be performed at screen unless prohibited by local regulations)
• • 10. Active and/or severe infections, including any ongoing infection requiring IV anti microbial treatment
• • 11. Have a current diagnosis of active tuberculosis
• • 12. Active HBV and a positive serological test for HBV (except seropositive due to HBV vaccination) or hepatitis C virus (HCV)
• • 13. Ongoing immunosuppressant treatment; corticosteroid treatment exceeding 20 mg/day prednisone or equivalent within 7 days of the first dose of study drug infusion
• • 14. Known hypersensitivity or allergy to the active principle and/or formulations' ingredients; history of severe allergy or anaphylaxis to murine or biologic agents
• • 15. Live or live attenuated vaccine within 28 days of the first dose of study drug infusion
• • 16. History of significant cardiac or vascular disease including, but not limited to: history of stroke, unstable angina, myocardial infarction or ventricular arrhythmia requiring medication or mechanical control within 6 months before randomisation; congestive heart failure according to the New York Heart Association (NYHA) Functional Classification class III or IV