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

Sponsor
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Study ID
NCT03456466
Phase
PHASE1/PHASE2
Status
Unknown

Conditions

Eligibility Criteria

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

Interventions

  • TQB2303 — DRUG
    375mg/m2 ，iv
  • Rituximab — DRUG
    375mg/m2 ，iv

Study Details

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).

Key Dates

Start date
May 1, 2017
Status verified
Mar 2018
Primary completion
Jun 30, 2018
Completion
Jun 30, 2018

Study Design

Enrollment
122 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: TQB2303
  • Active Comparator: Rituximab

Primary Outcome Measure

AUC [ Time Frame: 85 days ]

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