drugset
drugset / Trial / NCT05040906

A Study Comparing the Efficacy and Safety Between H-CHOP and R-CHOP in Untreated CD20-Positive Diffuse Large B-cell Lymphoma Patients

NCT05040906 ↗

Phase 3 Unknown 416 enrolled Shandong New Time Pharmaceutical Co., LTD
RandomizedParallel-groupQuadruple-blindTreatment

Summary

This trial is a Multicenter, randomized, double-blind, parallel, controlled, and equivalence phase Ⅲ study. Primary objective: The purpose is to compare the objective response rate of H02 (rituximab biosimilar) plus CHOP and rituximab plus CHOP, as first-line treatment of diffuse large B-cell lymphoma. Secondary objective: The purpose is to compare the safety of H02 combined with CHOP regimen and rituximab injection (Rituximab®) combined with CHOP regimen in the treatment of newly treated diffuse large B-cell lymphoma.

Timeline

Start
2020-10-13
Primary completion
2023-10-13
Completion
2023-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject H02 Unknown 375 mg/m2 Intravenous
Comparator Rituximab Monoclonal antibody 375 mg/m2 Intravenous
Comparator Cyclophosphamide Other / unclassified 750 mg/m2 Intravenous
Comparator Doxorubicin Other / unclassified 50 mg/m2 Intravenous
Comparator Prednisone Other / unclassified 100 mg Oral
Comparator Vincristine Small molecule 1.4 mg/m2 Intravenous

Indications

No indication recorded.