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

NCT03485118 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 137

Last updated 2018-04-02

No results posted yet for this study

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.

Conditions

  • Diffuse Large B-cell Lymphoma

Interventions

DRUG

HS006+CHOP

Drug:HS006 HS006 375 mg per square meter (mg/m\^2),administered intravenously(IV) on Day1 of each 21-day cycle for 6 cycles. Drug :Cyclophosphamide Cyclophosphamide 750mg per square metre(mg/m\^2),administered intravenously(IV) on Day 2 of each 21-day cycle. Drug :Doxorubicin Doxorubicin 50mg per square metre( mg/m\^2),administered intravenously(IV) on Day 2 of each 21-day cycle. Drug :Vincristine Vincristine 1.4mg(maximum 2.0mg) per square metre (mg/m\^2),administered intravenously(IV) on Day 2 of each 21-day cycle. Drug: Prednisone Prednisone 100 mg administered orally on Days 2-6 of each 21-day cycle.

DRUG

HS006+CHOP

Drug:HS006 HS006 500 mg per square meter (mg/m\^2),administered intravenously(IV) on Day1 of each 21-day cycle for 6 cycles. During cycle 1,HS006 also infused on Day 8 and 15. Drug :Cyclophosphamide Cyclophosphamide 750mg per square metre(mg/m\^2),administered intravenously(IV) on Day 2 of each 21-day cycle. Drug :Doxorubicin Doxorubicin 50mg per square metre( mg/m\^2),administered intravenously(IV) on Day 2 of each 21-day cycle. Drug :Vincristine Vincristine 1.4mg(maximum 2.0mg) per square metre (mg/m\^2),administered intravenously(IV) on Day 2 of each 21-day cycle. Drug: Prednisone Prednisone 100 mg administered orally on Days 1-5 of each 21-day cycle.

DRUG

Rituximab+CHOP

Drug:Rituxan Rituxan 375 mg per square metre (mg/m\^2), administered by intravenous (IV) on Day 1 of each 21-day cycle. Drug :Cyclophosphamide Cyclophosphamide 750mg per square metre(mg/m\^2),administered intravenously(IV) on Day 2 of each 21-day cycle. Drug :Doxorubicin Doxorubicin 50mg per square metre( mg/m\^2),administered intravenously(IV) on Day 2 of each 21-day cycle. Drug :Vincristine Vincristine 1.4mg(maximum 2.0mg) per square metre (mg/m\^2),administered intravenously(IV) on Day 2 of each 21-day cycle. Drug: Prednisone Prednisone 100 mg administered orally on Days 2-6 of each 21-day cycle.

Sponsors & Collaborators

  • Zhejiang Hisun Pharmaceutical Co. Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

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

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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 NCT03485118 on ClinicalTrials.gov