A Study to Compare the Bioequivalence and Safety of JHL1101 and Rituximab in CD20 Positive B Cell Lymphoma Patients
Study Details
Study Description
Brief Summary
This is a multicenter, randomized, double-blind, parallel group study to compare the PK, safety, tolerability, immunogenicity and PD of JHL1101 vs Rituxan in subjects with CD20-positive B cell lymphoma. The study duration is 13 weeks. Approximately 128 eligible subjects will be randomized in a 1:1 ratio to receive either JHL1101 (n=64) or Rituxan (n=64). Each subject will receive one intravenous (IV) infusions of the investigational product (IP) at the dose of 375mg/m2 on Day 1. Assessments of PK, safety, tolerability, immunogenicity, PD, and efficacy will be collected over the following 13-week period.
Condition or Disease | Intervention/Treatment | Phase |
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|
Phase 1 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: JHL1101 Single dose IV infusion of 375 mg/m2 of JHL1101 |
Biological: JHL1101
100 mg/10 mL solution in a single-use vial
|
Active Comparator: Rituxan Single dose IV infusion of 375 mg/m2 of Rituximab |
Biological: Rituximab
100 mg/10 mL solution in a single-use vial
|
Outcome Measures
Primary Outcome Measures
- AUC0~t [91 days]
Area under the concentration-time curve (AUC) from time 0 (predose) of the first infusion on Day 1 to the last quantifiable concentration
Secondary Outcome Measures
- AUC0-∞ [91 days]
AUC from time 0 of the first infusion on Day 1 extrapolated to infinity
- Cmax [91 days]
Maximum concentration after infusion
Eligibility Criteria
Criteria
Inclusion Criteria:
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CD20-positive B-cell lymphoma.
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Obtained CR (complete remission) or CRu (uncertain complete remission) after the prior therapy
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18 years to 75 years
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Signed an informed consent
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Adequate organ function, including the following
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Absolute neutrophil count (ANC) ≥ 1,500/uL; platelet count ≥ 75,000/uL; hemoglobin ≥ 8 g/dL
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Total bilirubin ≤ 1.5 times the upper limit of normal (ULN), aspartate transaminase (AST) and/or alanine aminotransferase (ALT) ≤ 2.5 times ULN
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Serum creatinine ≤ 1.5 times the ULN
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Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
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Chemotherapy: must not have received within 8 weeks of entry onto this study
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Radiotherapy: must not have received within 4 weeks of entry onto this study
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Recovery (to baseline or to Grade 1 or less) from prior treatment-related toxicities except alopecia
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Aagreement to practice contraception
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More than 6 months life expectancy.
Exclusion Criteria:
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Received any investigational drug within 28 days prior to study enrollment
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Received blood transfusion or any therapies with erythropoietin (EPO), granulocyte-stimulating factor (G-CSF) or granulocyte-macrophage colony-stimulating factor (GM-CSF) within 14 days prior to study enrollment
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Received previous immunotherapy
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Received or plan to receive a live vaccine within 28 days of study enrollment
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Major surgery within 28 days of study enrollment
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Received systemic steroid therapy with 28 days of study enrollment
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Received or plan to receive the hematopoietic cell transplant
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History of gastrointestinal perforation and/or fistula within 6 months prior to study enrollment
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Known allergic reactions against monoclonal antibody or rituximab.
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Received rituximab or other anti-CD20 monoclonal antibody
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Blood concentration of rituximab > 10 ug/mL during screen visit
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Human immunodeficiency virus (HIV) positive
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Hepatitis C virus (HCV) antigen and antibody positive
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Hepatitis B virus surface antigen (HBsAg) positive
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Body Mass Index (MBI) ≥ 28 kg/m2
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | First Hospital of Shanxi Medical University | Taiyuan | Shanxi | China | |
2 | Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College | Tianjin | Tianjin | China |
Sponsors and Collaborators
- JHL Biotech, Inc.
Investigators
- Principal Investigator: Lu-Gui Qiu, MD, Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- JHL-CLIN-1101-02