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

Primary Purpose

B Cell Lymphoma

Status
Terminated
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
JHL1101
Rituximab
Sponsored by
JHL Biotech, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for B Cell Lymphoma

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • First Hospital of Shanxi Medical University
  • Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

JHL1101

Rituxan

Arm Description

Single dose IV infusion of 375 mg/m2 of JHL1101

Single dose IV infusion of 375 mg/m2 of Rituximab

Outcomes

Primary Outcome Measures

AUC0~t
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-∞
AUC from time 0 of the first infusion on Day 1 extrapolated to infinity
Cmax
Maximum concentration after infusion

Full Information

First Posted
September 12, 2018
Last Updated
January 6, 2020
Sponsor
JHL Biotech, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03670888
Brief Title
A Study to Compare the Bioequivalence and Safety of JHL1101 and Rituximab in CD20 Positive B Cell Lymphoma Patients
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"
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Terminated
Why Stopped
The development was stopped due to company's strategy consideration
Study Start Date
November 16, 2018 (Actual)
Primary Completion Date
March 19, 2019 (Actual)
Study Completion Date
March 19, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
JHL Biotech, Inc.

4. Oversight

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
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
B Cell Lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
JHL1101
Arm Type
Experimental
Arm Description
Single dose IV infusion of 375 mg/m2 of JHL1101
Arm Title
Rituxan
Arm Type
Active Comparator
Arm Description
Single dose IV infusion of 375 mg/m2 of Rituximab
Intervention Type
Biological
Intervention Name(s)
JHL1101
Intervention Description
100 mg/10 mL solution in a single-use vial
Intervention Type
Biological
Intervention Name(s)
Rituximab
Intervention Description
100 mg/10 mL solution in a single-use vial
Primary Outcome Measure Information:
Title
AUC0~t
Description
Area under the concentration-time curve (AUC) from time 0 (predose) of the first infusion on Day 1 to the last quantifiable concentration
Time Frame
91 days
Secondary Outcome Measure Information:
Title
AUC0-∞
Description
AUC from time 0 of the first infusion on Day 1 extrapolated to infinity
Time Frame
91 days
Title
Cmax
Description
Maximum concentration after infusion
Time Frame
91 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: CD20-positive B-cell lymphoma. Obtained CR (complete remission) or CRu (uncertain complete remission) after the prior therapy 18 years to 75 years Signed an informed consent 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 Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 Chemotherapy: must not have received within 8 weeks of entry onto this study Radiotherapy: must not have received within 4 weeks of entry onto this study Recovery (to baseline or to Grade 1 or less) from prior treatment-related toxicities except alopecia Aagreement to practice contraception More than 6 months life expectancy. Exclusion Criteria: Received any investigational drug within 28 days prior to study enrollment 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 Received previous immunotherapy Received or plan to receive a live vaccine within 28 days of study enrollment Major surgery within 28 days of study enrollment Received systemic steroid therapy with 28 days of study enrollment Received or plan to receive the hematopoietic cell transplant History of gastrointestinal perforation and/or fistula within 6 months prior to study enrollment Known allergic reactions against monoclonal antibody or rituximab. Received rituximab or other anti-CD20 monoclonal antibody Blood concentration of rituximab > 10 ug/mL during screen visit Human immunodeficiency virus (HIV) positive Hepatitis C virus (HCV) antigen and antibody positive Hepatitis B virus surface antigen (HBsAg) positive Body Mass Index (MBI) ≥ 28 kg/m2
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lu-Gui Qiu, MD
Organizational Affiliation
Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Official's Role
Principal Investigator
Facility Information:
Facility Name
First Hospital of Shanxi Medical University
City
Taiyuan
State/Province
Shanxi
Country
China
Facility Name
Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
City
Tianjin
State/Province
Tianjin
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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