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Study of TQB2303 in Patients With Aggressive CD20 Positive Non-Hodgkin's Lymphoma

NCT03456466 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 122

Last updated 2018-03-07

No results posted yet for this study

Summary

Primary Outcome Measures:

Area under the curve (AUC) forTQB2303 and rituximab concentrations \[ Time Frame: 85 days \]

Secondary Outcome Measures:

The Maximum Concentration (Cmax) of the TQB2303 and rituximab \[ Time Frame: 85 days \] The area under the plasma concentration-time curve from 0 to inf (infinite) time (AUC0-∞); The time to reach the maximum plasma concentration after treatment (Tmax) Total clearance (CL); Elimination of half-life (t1 / 2); Apparent distribution volume (Vd).

Conditions

  • Non-hodgkin's Lymphoma

Interventions

DRUG

TQB2303

375mg/m2 ，iv

DRUG

Rituximab

375mg/m2 ，iv

Sponsors & Collaborators

  • Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-05-01
Primary Completion
2018-06-30
Completion
2018-06-30

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03456466 on ClinicalTrials.gov