Multicenter, Randomized, Double-blind, Parallel Controlled, Phase III Clinical Study to Compare the Efficacy and Safety of TQB2303 in Conbination With CHOP Regimen (T-CHOP) Versus Rituximab in Combination With CHOP Regimen (R-CHOP) in Previously Untreated Subjects With CD20-Positive Diffuse Large B-cell Lymphoma (DLBCL)

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.31 sites in 1 country230 target enrollmentJanuary 10, 2019

ConditionsDiffuse Large B-cell Lymphoma

InterventionsTQB2303 Rituximab

DrugsTQB2303 Rituximab

Overview

Phase: Phase 3
Intervention: TQB2303
Conditions: Diffuse Large B-cell Lymphoma
Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Enrollment: 230
Locations: 31
Primary Endpoint: Overall response rate (ORR)
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The Purpose of This Study is to Compare the Efficacy, Safety, Immunogenicity and Pharmacokinetics between TQB2303 and Rituximab in Combination With CHOP in Previously Untreated Patients with Diffuse Large B-cell Lymphoma

Registry

clinicaltrials.gov

Start Date

January 10, 2019

End Date

December 30, 2020

Last Updated

6 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Untreated CD20-positive DLBCL patients confirmed by histopathology or cytology.
•18 years to 75 years; Male or female patients.
•International Prognostic Index (IPI) score of 0 to
•Eastern Cooperative Oncology Group (ECOG) performance status of 0 to
•More than 6 months life expectancy judged by the researchers.
•At least one measurable lesions: for nodal tumor mass, more than 1.5 cm in the long axis and more than 1.0 cm in the short axis; for extranodal tumor mass, more than 1.0 cm in the long axis.
•left ventricular ejection fraction (LVEF) measured by the Cardiac echocardiography greater than or equal to 50%.
•Adequate hematologic function, no matter the bone marrow was attacked or not, as follows:absolute neutrophil count (ANC) ≥1.5×10\^9/L and platelet count≥75×\^9/L.
•Understood and Signed an informed consent form.

Exclusion Criteria

•Known allergic reactions against human or murine monoclonal antibody, murine products, or foreign proteins.
•Known allergic reactions against any component of CHOP regimen.
•Previous treatment for DLBCL, including chemotherapy, immunotherapy, partial radiotherapy for lymphoma, or surgical treatment (excluding tumor mass biopsies and surgical resection for non-lymphoma lesions), or prior use of any monoclonal antibody within 3 month.
•T-cell/histiocyte-rich large B-cell lymphoma, Primary DLBCL of the CNS, Primary cutaneous DLBCL, leg type, EBV-positive DLBCL of the elderly (EBV + DLBCL), EBV-positive DLBCL of the elderly (EBV + DLBCL), DLBCL associated with chronic infammation, Lymphomatoid granulomatosis, Primary mediastinal (thymic) large B-cell lymphoma (PMBL), ALK-positive large B-cell lymphoma, ALK-positive large B-cell lymphoma, ALK-positive large B-cell lymphoma, high-grade B-cell lymphoma (high-grade B-cell lymphoma with MYC, with or without concurrent in BCL2 and/or BCL6 gene rearrangements, high-grade B-cell lymphoma, NOS), B-cell lymphoma, Not categorizable, Characteristics between DLBCL and classical Hodgkin's lymphoma, transformed DLBCL, DLBCL secondary central nervous system invasion;
•Other malignant tumors that have been or are currently suffering (healed skin basal cell carcinoma or cutaneous squamous cell carcinoma, or cutaneous melanoma or cervical carcinoma in situ).
•Significantly poorly controlled diseases that can affect adherence to the study protocol, such as severe cardiovascular disease (such as the New York Heart Association class III or IV heart disease, myocardial infarction or unstable arrhythmia in the last 6 months or Unstable angina, severe hypertension, peripheral nervous system or central nervous system disease;
•Patients with a history of progressive multifocal leukoencephalopathy.
•Continuous corticosteroid treatment being received, dose \>30 mg/day prednisone or equivalent dose of corticosteroids ≥10 days.
•Participation in another interventional clinical trial in the past 3 months.
•Patients who received or underwent major surgeries within 28 days prior to enrollment, or patients with unsurgical wounds.