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A Study to Compare the Bioequivalence and Safety of JHL1101 and Rituximab in CD20 Positive B Cell Lymphoma Patients

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03670888
Recruitment Status : Not yet recruiting
First Posted : September 14, 2018
Last Update Posted : September 14, 2018
Sponsor:
Information provided by (Responsible Party):
JHL Biotech, Inc.

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
B Cell Lymphoma Biological: JHL1101 Biological: Rituximab Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 128 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: "A Multicenter, Randomized, Double-blind, Parallel-controlled Trial to Compare the Bioequivalence and Safety of the Recombinant Human-Mouse Chimeric Anti-CD20 Monoclonal Antibody Injection (JHL1101) and Rituximab Injection in CD20 Positive B Cell Lymphoma Patients"
Estimated Study Start Date : November 30, 2018
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : April 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma
Drug Information available for: Rituximab

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. AUC0~t [ Time Frame: 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 :
  1. AUC0-∞ [ Time Frame: 91 days ]
    AUC from time 0 of the first infusion on Day 1 extrapolated to infinity

  2. Cmax [ Time Frame: 91 days ]
    Maximum concentration after infusion



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 to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. CD20-positive B-cell lymphoma.
  2. Obtained CR (complete remission) or CRu (uncertain complete remission) after the prior therapy
  3. 18 years to 75 years
  4. Signed an informed consent
  5. Adequate organ function, including the following

    • Absolute neutrophil count (ANC) ≥ 1,500/uL; platelet count ≥ 75,000/uL; hemoglobin ≥ 8 g/dL
    • Total bilirubin ≤ 1.5 times the upper limit of normal (ULN), aspartate transaminase (AST) and/or alanine aminotransferase (ALT) ≤ 2.5 times ULN
    • Serum creatinine ≤ 1.5 times the ULN
  6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
  7. Chemotherapy: must not have received within 8 weeks of entry onto this study
  8. Radiotherapy: must not have received within 4 weeks of entry onto this study
  9. Recovery (to baseline or to Grade 1 or less) from prior treatment-related toxicities except alopecia
  10. Aagreement to practice contraception
  11. More than 6 months life expectancy.

Exclusion Criteria:

  1. Received any investigational drug within 28 days prior to study enrollment
  2. 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
  3. Received previous immunotherapy
  4. Received or plan to receive a live vaccine within 28 days of study enrollment
  5. Major surgery within 28 days of study enrollment
  6. Received systemic steroid therapy with 28 days of study enrollment
  7. Received or plan to receive the hematopoietic cell transplant
  8. History of gastrointestinal perforation and/or fistula within 6 months prior to study enrollment
  9. Known allergic reactions against monoclonal antibody or rituximab.
  10. Received rituximab or other anti-CD20 monoclonal antibody
  11. Blood concentration of rituximab > 10 ug/mL during screen visit
  12. Human immunodeficiency virus (HIV) positive
  13. Hepatitis C virus (HCV) antigen and antibody positive
  14. Hepatitis B virus surface antigen (HBsAg) positive
  15. Body Mass Index (MBI) ≥ 28 kg/m2

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03670888


Contacts
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Contact: Rong Chen, MD +86-27-8787 9208 ZrChen@jhlbiotech.com

Locations
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China, Shanxi
First Hospital of Shanxi Medical University Not yet recruiting
Taiyuan, Shanxi, China
Contact: Weihua Zhang, MD       zwhlzh@126.com   
Principal Investigator: Weihua Zhang, MD         
China, Tianjin
Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College Not yet recruiting
Tianjin, Tianjin, China
Contact: Lu-Gui Qiu, MD    +86-22-23909095    drqiu99@medmail.com.cn   
Principal Investigator: Lu-Gui Qiu, MD         
Sponsors and Collaborators
JHL Biotech, Inc.
Investigators
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Principal Investigator: Lu-Gui Qiu, MD Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

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Responsible Party: JHL Biotech, Inc.
ClinicalTrials.gov Identifier: NCT03670888     History of Changes
Other Study ID Numbers: JHL-CLIN-1101-02
First Posted: September 14, 2018    Key Record Dates
Last Update Posted: September 14, 2018
Last Verified: September 2018
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
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Rituximab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents