- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03670888
A Study to Compare the Bioequivalence and Safety of JHL1101 and Rituximab in CD20 Positive B Cell Lymphoma Patients
January 6, 2020 updated by: JHL Biotech, Inc.
"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"
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
1
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Shanxi
-
Taiyuan, Shanxi, China
- First Hospital of Shanxi Medical University
-
-
Tianjin
-
Tianjin, Tianjin, China
- Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: JHL1101
Single dose IV infusion of 375 mg/m2 of JHL1101
|
100 mg/10 mL solution in a single-use vial
|
Active Comparator: Rituxan
Single dose IV infusion of 375 mg/m2 of Rituximab
|
100 mg/10 mL solution in a single-use vial
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
91 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
AUC0-∞
Time Frame: 91 days
|
AUC from time 0 of the first infusion on Day 1 extrapolated to infinity
|
91 days
|
Cmax
Time Frame: 91 days
|
Maximum concentration after infusion
|
91 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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 record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 16, 2018
Primary Completion (Actual)
March 19, 2019
Study Completion (Actual)
March 19, 2019
Study Registration Dates
First Submitted
September 12, 2018
First Submitted That Met QC Criteria
September 12, 2018
First Posted (Actual)
September 14, 2018
Study Record Updates
Last Update Posted (Actual)
January 9, 2020
Last Update Submitted That Met QC Criteria
January 6, 2020
Last Verified
January 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Lymphoma, Non-Hodgkin
- Lymphoma
- Lymphoma, B-Cell
- Physiological Effects of Drugs
- Antirheumatic Agents
- Antineoplastic Agents
- Immunologic Factors
- Antineoplastic Agents, Immunological
- Rituximab
Other Study ID Numbers
- JHL-CLIN-1101-02
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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