NCT03003039

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
85

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jun 2017

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 20, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 26, 2016

Completed
5 months until next milestone

Study Start

First participant enrolled

June 5, 2017

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 20, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 20, 2019

Completed
Last Updated

March 23, 2021

Status Verified

March 1, 2021

Enrollment Period

2 years

First QC Date

December 20, 2016

Last Update Submit

March 19, 2021

Conditions

B-Cell Lymphoma

Keywords

GB241RituximabB-cell Lymphoma

Outcome Measures

Primary Outcomes (1)

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

    85 days

Secondary Outcomes (5)

  • AUC for GB241 and rituximab concentrations

    1 week, 2 weeks, 4 weeks, 8 weeks and 12 weeks

  • Maximum observed concentration of the GB241 and rituximab

    85 days

  • Degree of clearance from baseline of CD19+ , CD20+ B-cells between the two study arms

    85 days

  • Comparison of AEs between the two study arms

    85 days

  • Comparison of the incidence rate of HACA（host anti-chimeric antibody） between the two study arms

    85 days

Study Arms (2)

GB241

EXPERIMENTAL

GB241:375 mg/m2, iv, one infusion

Biological: GB241

Rituximab

ACTIVE COMPARATOR

Rituximab: 375 mg/m2, iv, one infusion

Biological: Rituximab

Interventions

GB241BIOLOGICAL

Single intravenous infusion (IV) 375 mg/m2

GB241
RituximabBIOLOGICAL

Single intravenous infusion (IV) 375 mg/m2

Rituximab

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100076, China

Location

MeSH Terms

Conditions

Lymphoma, B-Cell

Interventions

Rituximab

Condition Hierarchy (Ancestors)

Lymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-DerivedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 20, 2016

First Posted

December 26, 2016

Study Start

June 5, 2017

Primary Completion

May 20, 2019

Study Completion

May 20, 2019

Last Updated

March 23, 2021

Record last verified: 2021-03

Locations

CN(1)