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

Primary Purpose

B-Cell Lymphoma

Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
GB241
Rituximab
Sponsored by
Nanjing Yoko Biomedical Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for B-Cell Lymphoma focused on measuring GB241, Rituximab, B-cell Lymphoma

Eligibility Criteria

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

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

Sites / Locations

  • Cancer Hospital Chinese Academy of Medical Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

GB241

Rituximab

Arm Description

GB241:375 mg/m2, iv, one infusion

Rituximab: 375 mg/m2, iv, one infusion

Outcomes

Primary Outcome Measures

Area under the curve (AUC) for GB241 and rituximab concentrations

Secondary Outcome Measures

AUC for GB241 and rituximab concentrations
Maximum observed concentration of the GB241 and rituximab
Degree of clearance from baseline of CD19+ , CD20+ B-cells between the two study arms
Comparison of AEs between the two study arms
Comparison of the incidence rate of HACA（host anti-chimeric antibody） between the two study arms

Full Information

First Posted
December 20, 2016
Last Updated
March 19, 2021
Sponsor
Nanjing Yoko Biomedical Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT03003039
Brief Title
A Study Comparing GB241 And Rituximab in Patients With B-cell Non-Hodgkin's Lymphoma
Official Title
A Study Comparing GB241 And Rituximab in Patients With B-cell Non-Hodgkin's Lymphoma
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
June 5, 2017 (Actual)
Primary Completion Date
May 20, 2019 (Actual)
Study Completion Date
May 20, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nanjing Yoko Biomedical Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The purpose of this study is the area under the curve (AUC) for GB241 and rituximab concentrations.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
B-Cell Lymphoma
Keywords
GB241, Rituximab, B-cell Lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
85 (Actual)

8. Arms, Groups, and Interventions

Arm Title
GB241
Arm Type
Experimental
Arm Description
GB241:375 mg/m2, iv, one infusion
Arm Title
Rituximab
Arm Type
Active Comparator
Arm Description
Rituximab: 375 mg/m2, iv, one infusion
Intervention Type
Biological
Intervention Name(s)
GB241
Intervention Description
Single intravenous infusion (IV) 375 mg/m2
Intervention Type
Biological
Intervention Name(s)
Rituximab
Intervention Description
Single intravenous infusion (IV) 375 mg/m2
Primary Outcome Measure Information:
Title
Area under the curve (AUC) for GB241 and rituximab concentrations
Time Frame
85 days
Secondary Outcome Measure Information:
Title
AUC for GB241 and rituximab concentrations
Time Frame
1 week, 2 weeks, 4 weeks, 8 weeks and 12 weeks
Title
Maximum observed concentration of the GB241 and rituximab
Time Frame
85 days
Title
Degree of clearance from baseline of CD19+ , CD20+ B-cells between the two study arms
Time Frame
85 days
Title
Comparison of AEs between the two study arms
Time Frame
85 days
Title
Comparison of the incidence rate of HACA（host anti-chimeric antibody） between the two study arms
Time Frame
85 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: 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
Facility Information:
Facility Name
Cancer Hospital Chinese Academy of Medical Sciences
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100076
Country
China

12. IPD Sharing Statement

Learn more about this trial

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

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