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

Sponsor
Nanjing Yoko Biomedical Co., Ltd.
Study ID
NCT03003039
Phase
PHASE1
Status
Completed

Conditions

  • B-Cell Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • GB241 — BIOLOGICAL
    Single intravenous infusion (IV) 375 mg/m2
  • Rituximab — BIOLOGICAL
    Single intravenous infusion (IV) 375 mg/m2

Study Details

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

Key Dates

Start date
Jun 5, 2017
Status verified
Mar 2021
Primary completion
May 20, 2019
Completion
May 20, 2019

Study Design

Enrollment
85 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: GB241
    GB241:375 mg/m2, iv, one infusion
  • Active Comparator: Rituximab
    Rituximab: 375 mg/m2, iv, one infusion

Primary Outcome Measure

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

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