drugset
drugset / Trial / NCT03485118

RHCACD20MA (HS006) Combined With CHOP (Hi-CHOP) in Patients With Previously Untreated Diffuse Large B-cell Lymphoma

NCT03485118 ↗

Phase 2 Completed 137 enrolled Zhejiang Hisun Pharmaceutical Co. Ltd.
RandomizedParallel-groupSingle-blindTreatment

Summary

Primary objective: To evaluate the efficacy of recombinant human-mouse chimeric anti-CD20 monoclonal antibody injection(HS006) with CHOP(Hi-CHOP) versus Rituximab with CHOP (R-CHOP) in patients with previously untreated Diffuse Large B-cell Lymphoma as first line treatment. Secondary objective: To evaluate the safety of recombinant human-mouse chimeric anti-CD20 monoclonal antibody injection(HS006) with CHOP(Hi-CHOP) in patients with previously untreated Diffuse Large B-cell Lymphoma. To study the pharmacokinetics of recombinant human-mouse chimeric anti-CD20 monoclonal antibody injection(HS006) in patients with previously untreated Diffuse Large B-cell Lymphoma.

Timeline

Start
2016-05-12
Primary completion
2016-08-12
Completion
2018-01-14

Drugs

EvaluationDrugModalityDoseRoute
Comparator Rituximab Monoclonal antibody 375 mg/m2 Intravenous
Subject Zuberitamab Monoclonal antibody 375 mg/m2 Intravenous
Subject Zuberitamab Monoclonal antibody 500 mg/m2 Intravenous
Background Cyclophosphamide Other / unclassified 750 mg/m2 Intravenous
Background Doxorubicin Other / unclassified 50 mg/m2 Intravenous
Background Prednisone Other / unclassified 100 mg Oral
Background Vincristine Small molecule 1.4 mg/m2 Intravenous

Indications

diffuse large B-cell lymphoma