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Antineoplastic Agents, Immunological

Immunologic Factors

Participants received six cycles of H02(375 mg/m2) combined with six cycles of standard cyclophosphamide,doxorubicin,vincristine,and prednisone/prednisolone(CHOP) chemotherapy(21-day cycles).

Participants received six cycles of Rituxan combined with six cycles of standard cyclophosphamide,doxorubicin,vincristine,and prednisone(CHOP) chemotherapy(21-day cycles).

Drug:H02 375 mg/m2,administered intravenously(IV) on Day1 of each 21-day cycle for 6 cycles.

Drug : Cyclophosphamide 750 mg/m2,administered intravenously(IV) on Day 2 of each 21-day cycle.

Drug:Doxorubicin 50 mg/m2,administered intravenously(IV) on Day 2 of each 21-day cycle.

Drug :Vincristine 1.4mg mg/m2,administered intravenously(IV) on Day 2 of each 21-day cycle.

Drug: Prednisone 100 mg administered orally on Days 2-6 of each 21-day cycle.

H02+CHOP

Drug: Rituxan 375 mg/m2,administered intravenously(IV) on Day1 of each 21-day cycle for 6 cycles.

Drug : Cyclophosphamide 750 mg/m2,administered intravenously(IV) on Day 2 of each 21-day cycle.

Drug: Doxorubicin 50 mg/m2,administered intravenously(IV) on Day 2 of each 21-day cycle.

Drug : Vincristine 1.4mg mg/m2,administered intravenously(IV) on Day 2 of each 21-day cycle.

Drug: Prednisone 100 mg administered orally on Days 2-6 of each 21-day cycle.

Rituxan +CHOP

jianfeng zhou, Doctor

Shaohong Yin

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.

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

A Phase 3, Randomized, Double-blind Study of H02 Plus CHOP Versus R-CHOP in Patients With Diffuse Large B-cell Lymphoma

To evaluate the objective response rate (ORR) in patients with previously untreated Diffuse Large B-cell Lymphoma after six periods of treatment.

CR was defined as the complete disappearance of all previously detectable disease signs. CR rate was percentage of participants with a CR event.

PFS was defined as the time from randomization to first occurrence of disease progression, relapse, or death from any cause. The proportion of subjects without disease progression or death from any cause after randomization for one year.

The time from the first assessment of complete response or partial response to the first assessment of PD or death after randomization within 1 year.

The proportion of subjects who did not die from any cause after randomization for 1 year.

OS was defined as the time from randomization to death from any cause. Percentage of subjects without disease progression, death, or any interruption of treatment at 1 year of randomization

Shandong New Time Pharmaceutical Co., LTD

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Study Comparing the Efficacy and Safety Between H-CHOP and R-CHOP in Untreated CD20-Positive Diffuse Large B-cell Lymphoma Patients	NCT05040906	Recruiting	H02+CHOP Rituxan +CHOP	18 Years - 75 Years	Shandong New Time Pharmaceutical Co., LTD
A Study Comparing the Efficacy and Safety Between H-CHOP and R-CHOP in Untreated CD20-Positive Diffuse Large B-cell Lymphoma Patients	NCT05040906	Recruiting	H02+CHOP Rituxan +CHOP	18 Years - 75 Years	Shandong New Time Pharmaceutical Co., LTD

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