Status:
WITHDRAWN
Evaluate the Efficacy and Safety of HLX01 Versus Mabthera in Patients With Low Tumour Burden Follicular Lymphoma.
Lead Sponsor:
Shanghai Henlius Biotech
Conditions:
CD20-positive Follicular Lymphoma, With Low Tumour Burden
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The study is a Phase 3 multi-centre, randomised, double-blind, parallel-arm study to evaluate the efficacy and safety of HLX01 versus European Union (EU)-sourced Mabthera® as first line treatment in p...
Eligibility Criteria
Inclusion
- Voluntary written informed consent before any study-related activities
- ≥ 18 years of age
- 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) \[11\]
- Low tumour burden according to the GELF criteria
- The Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Availability of tumour sample within 12 months before start of study drug treatment
- 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
- Adequate organ function
Exclusion
- 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
- Transformation to high-grade lymphoma
- Patients with advanced disease that are considered for treatment with combined chemo immunotherapy
- Presence or history of central nervous system (CNS) lymphoma involvement
- Treatment with an investigational agent within 28 days of the first dose of study drug infusion
- Prior treatment with a chimeric antibody, including HLX01 and Mabthera®
- 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
- Major surgery within 28 days of the first dose of study drug infusion (excluding lymph node biopsy)
- Known human immunodeficiency virus (HIV) infection (Serological test for HIV should be performed at screen unless prohibited by local regulations)
- Active and/or severe infections, including any ongoing infection requiring IV anti microbial treatment
- Have a current diagnosis of active tuberculosis
- Active HBV and a positive serological test for HBV (except seropositive due to HBV vaccination) or hepatitis C virus (HCV)
- Ongoing immunosuppressant treatment; corticosteroid treatment exceeding 20 mg/day prednisone or equivalent within 7 days of the first dose of study drug infusion
- Known hypersensitivity or allergy to the active principle and/or formulations' ingredients; history of severe allergy or anaphylaxis to murine or biologic agents
- Live or live attenuated vaccine within 28 days of the first dose of study drug infusion
- 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
Key Trial Info
Start Date :
October 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2022
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04671420
Start Date
October 1 2020
End Date
October 1 2022
Last Update
December 17 2020
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