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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. Identifier: NCT04671420
Recruitment Status : Withdrawn (sponsor strategy decision)
First Posted : December 17, 2020
Last Update Posted : December 17, 2020
Information provided by (Responsible Party):
Shanghai Henlius Biotech

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 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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma
Drug Information available for: Rituximab

Arm Intervention/treatment
Experimental: HLX01 Drug: HLX01
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®) Drug: 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.

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. AEs [ Time Frame: up to 12 months ]
    adverse events

  2. SAEs [ Time Frame: up to 12 months ]
    serious adverse events

  3. Immunogenicity [ Time Frame: up to 12 months ]
    ADA and neutralising antibody

  4. Time-to-progression of disease (TTPD) [ Time Frame: up to 12 months ]
    Time-to-progression of disease

  5. PFS [ Time Frame: up to 12 months ]
    progression-free survival

  6. Cmax [ Time Frame: up to 12 months ]
    max blood cocentration

  7. Ctrough [ Time Frame: up to 12 months ]
    trough serum concentration after each dose during induction period and selected doses thereafter

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Responsible Party: Shanghai Henlius Biotech Identifier: NCT04671420    
Other Study ID Numbers: HLX01-FL03
First Posted: December 17, 2020    Key Record Dates
Last Update Posted: December 17, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lymphoma, Follicular
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents