Evaluate the Efficacy and Safety of HLX01 Versus Mabthera in Patients With Low Tumour Burden Follicular Lymphoma.
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04671420|
Recruitment Status : Withdrawn (sponsor strategy decision)
First Posted : December 17, 2020
Last Update Posted : December 17, 2020
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 patients with low tumour burden FL.
The study will consist of a Screening Period (up to 42 days), Treatment Period (Week 1 to Week 44/Month 11), and End of Study (EOS; Month 12 Visit). Approximately 212 patients (106 in each treatment group) will be enrolled.
Utilising a 1-sided 97.5% CI for the risk difference, a reference proportion of 83.2% for Mabthera®, delta for non-inferiority of -17%, and assuming a true difference of 1%, a sample size of 106 patients per arm (212 total) provides approximately 85% power to show non-inferiority of HLX01 to Mabthera® on a primary endpoint of risk difference in ORR up to Week 28. No dropout is included, as all patients will either have data provided for ORR (based on best response), or will be classed as non-responder.
|Condition or disease||Intervention/treatment||Phase|
|CD20-positive Follicular Lymphoma, With Low Tumour Burden||Drug: HLX01 Drug: Mabthera®||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Phase 3 Multi-Centre, Randomised, Double-Blind, Parallel-Arm Study to Evaluate the Efficacy and Safety of HLX01 Versus Rituximab (Mabthera®) as First Line Treatment in Patients With Low Tumour Burden Follicular Lymphoma.|
|Estimated Study Start Date :||October 2020|
|Estimated Primary Completion Date :||April 2022|
|Estimated Study Completion Date :||October 2022|
Patients will receive HLX01 intravenous (IV) infusion once a week for 4 weeks induction treatment (on Days 1, 8, 15, and 22), and then continue to receive maintenance treatment at Weeks 12, 20, 28, 36, and 44.
|Active Comparator: EU-sourced rituximab (Mabthera®)||
Patients will receive Mabthera® intravenous (IV) infusion once a week for 4 weeks induction treatment (on Days 1, 8, 15, and 22), and then continue to receive maintenance treatment at Weeks 12, 20, 28, 36, and 44.
- Overall Response Rate [ Time Frame: rom the first dose of study drug through Week 28 ]Overall Response Rate up to Week 28, defined as the proportion of patients achieving either complete response (CR) or PR as best response from the first dose of study drug through Week 28 as assessed by a blinded independent review committee according to the Modified Lugano Response Classification 2014.
- AEs [ Time Frame: up to 12 months ]adverse events
- SAEs [ Time Frame: up to 12 months ]serious adverse events
- Immunogenicity [ Time Frame: up to 12 months ]ADA and neutralising antibody
- Time-to-progression of disease (TTPD) [ Time Frame: up to 12 months ]Time-to-progression of disease
- PFS [ Time Frame: up to 12 months ]progression-free survival
- Cmax [ Time Frame: up to 12 months ]max blood cocentration
- Ctrough [ Time Frame: up to 12 months ]trough serum concentration after each dose during induction period and selected doses thereafter