A Study Comparing GB241 And Rituximab in Patients With B-cell Non-Hodgkin's Lymphoma

March 19, 2021 updated by: Nanjing Yoko Biomedical Co., Ltd.
The purpose of this study is the area under the curve (AUC) for GB241 and rituximab concentrations.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

85

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

  • China
    • Beijing
      • Beijing, Beijing, China, 100076
        • Cancer Hospital Chinese Academy of Medical Sciences

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:

  • having histologically confirmed NHL expressing CD20 antigen
  • having obtained CR (complete remission) or CRu (uncertain complete remission) after the prior therapy
  • signed an informed consent form which was approved by the institutional review board of the respective medical center
  • aged from 18 to 75 years
  • ECOG performance status of 0 to 1
  • expected survival of at least ≥ 3 months

Exclusion Criteria:

  • had received rituximab or other anti-CD20(+) monoclonal antibody treatment within 1 year before enrollment
  • having to be at least 4 weeks beyond prior anticancer therapy including corticosteroid, or have not recovered from significant toxicities of prior therapy
  • participating in other clinical trial within 30 days before enrolment
  • with serious hematologic dysfunction (white blood cell count of <3.0×103/uL; absolute neutrophil count of <1.5×103/ uL; platelet count of < 75×103/uL; hemoglobin level of < 8.0 g/dL); hepatic dysfunction (total bilirubin level of > 1.5×ULN; aspartate amino transferase (AST) and alanine amino transferase (ALT) levels of >2.5 × ULN; renal dysfunction (serum creatinine level of > 1.5×ULN ); and International normalized ratio (INR) and partial thromboplastin time or activated partial thromboplastin time (aPTT) > 1.5 × ULN (unless on therapeutic coagulation)
  • had received live vaccine within 4 weeks prior to study entry
  • with other malignancies ; or central nervous system (CNS) lymphoma, AIDS-related lymphoma; or active opportunistic infection, a serious nonmalignant disease
  • seropositive for HCV antibody, or HIV antibody, or hepatitis B virus surface antigen (HBsAg). HBc antibody seropositive, but HBV DNA and HBsAg negative patients may participle following consultation with a hepatitis expert regarding monitoring and use of HBV antiviral therapy, and provided they agree to receive treatment as indicated
  • recent major surgery (within 28 days prior to study entry )
  • with a history of allergic reaction or protein product allergy including murine proteins
  • pregnant or lactating or not accepted birth control methods including male patients
  • patients considered unsuitable by PI
  • previous malignant tumor except cured cervical cancer,basal cell carcinoma and squamous cell skin cancer
  • active opportunistic infections and other serious non neoplastic diseases

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: GB241
GB241:375 mg/m2, iv, one infusion
Biological: GB241
Single intravenous infusion (IV) 375 mg/m2
Active Comparator: Rituximab
Rituximab: 375 mg/m2, iv, one infusion
Biological: Rituximab
Single intravenous infusion (IV) 375 mg/m2

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Area under the curve (AUC) for GB241 and rituximab concentrations
Time Frame: 85 days
85 days

Secondary Outcome Measures

Outcome Measure
Time Frame
AUC for GB241 and rituximab concentrations
Time Frame: 1 week, 2 weeks, 4 weeks, 8 weeks and 12 weeks
1 week, 2 weeks, 4 weeks, 8 weeks and 12 weeks
Maximum observed concentration of the GB241 and rituximab
Time Frame: 85 days
85 days
Degree of clearance from baseline of CD19+ , CD20+ B-cells between the two study arms
Time Frame: 85 days
85 days
Comparison of AEs between the two study arms
Time Frame: 85 days
85 days
Comparison of the incidence rate of HACA（host anti-chimeric antibody） between the two study arms
Time Frame: 85 days
85 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nanjing Yoko Biomedical Co., Ltd.

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)

June 5, 2017

Primary Completion (Actual)

May 20, 2019

Study Completion (Actual)

May 20, 2019

Study Registration Dates

First Submitted

December 20, 2016

First Submitted That Met QC Criteria

December 23, 2016

First Posted (Estimate)

December 26, 2016

Study Record Updates

Last Update Posted (Actual)

March 23, 2021

Last Update Submitted That Met QC Criteria

March 19, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GB241NHL1

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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