A Pharmacokinetic and Pharmacodynamic Study Comparing HLX01 And Rituximab in Patients With CD20-Positive, B-cell Lymphoma

Sponsor: Shanghai Henlius Biotech
Study ID: NCT02584920
Phase: PHASE1/PHASE2
Status: Completed

Conditions

B-cell Non Hodgkin's Lymphoma

Eligibility Criteria

Sex: ALL
Age: 18 Years - 65 Years
Healthy Volunteers: Not accepted

Interventions

HLX01 — DRUG
Rituximab — DRUG

Study Details

Randomised, double-blind, parallel group study to compare PK and PD profiles between HLX01 and rituximab (MabThera®) in patients with CD20+ B-cell Lymphoma.

Key Dates

Start date: Oct 31, 2014
Status verified: May 2022
Primary completion: Aug 31, 2015
Completion: Aug 31, 2015

Study Design

Enrollment: 87 participants (actual)
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Arms

Experimental: HLX01
375mg/m2 iv single dose
Active Comparator: Rituximab
375mg/m2 iv single dose

Primary Outcome Measure

Area under the curve (AUC) for HLX01 and rituximab concentrations [ Time Frame: 91 days ]