A randomized, multiple-dose, multicenter, comparative parallel study to evaluate the safety and efficacy of intravenous infusion of rituximab (Hetero) and reference medicinal product (Rituximab, Roche) in Indian patients of non-hodgkin's lymphoma (HERILY)

A randomized, multiple-dose, multicenter, comparative parallel study to evaluate the safety and efficacy of intravenous infusion of rituximab (Hetero) and reference medicinal product (Rituximab, Roche) in Indian patients of non-hodgkin's lymphoma (HERILY)

Objective: To compare the antitumor efficacy, safety, and pharmacodynamic (PD) characteristics of Hetero-rituximab (test) with reference medicinal product (rituximab, Roche) in non-Hodgkin's lymphoma. Patients and Methods: One hundred and thirty-five patients with diffuse large B-cell lymphoma...

Full description

Saved in:
Bibliographic Details
Main Authors: Suresh Advani, Ghanashyam Biswas, Shubhadeep Sinha, Neetu Naidu Rayala, Sreenivasa Chary, Pankaj Thakur, Anushrita, Santanu Tripathi, Vamsi Krishna Bandi
Format: Article
Language:English
Published: Thieme Medical and Scientific Publishers Pvt. Ltd. 2018-01-01
Series:Indian Journal of Medical and Paediatric Oncology
Subjects:
Diffuse large B-cell lymphoma
non-Hodgkin's lymphoma
rituximab
Online Access:http://www.ijmpo.org/article.asp?issn=0971-5851;year=2018;volume=39;issue=3;spage=316;epage=320;aulast=Advani
Tags: Add Tag
No Tags, Be the first to tag this record!
Description
Summary:Objective: To compare the antitumor efficacy, safety, and pharmacodynamic (PD) characteristics of Hetero-rituximab (test) with reference medicinal product (rituximab, Roche) in non-Hodgkin's lymphoma. Patients and Methods: One hundred and thirty-five patients with diffuse large B-cell lymphoma (DLBCL) were randomized to receive intravenous infusion of either test or reference product. Efficacy (best overall response [BOR] rate [primary end point]), safety, PD (CD19), and immunological assessments (secondary end points) were done at the end of cycle 3 and cycle 6. Results: At the end of 6 cycles, BOR rate was 73.47% in Hetero-rituximab test arm compared to the 69.09% in reference arm. Anti-rituximab antibodies were found to be negative at cycle 3 and cycle 6 for all patients. Patients treated with Hetero-rituximab show a significant depletion in CD19+ cell which was comparable with reference drug. Safety and immunogenic potential of the test drug was comparable to the reference drug in the patients of DLBCL. Conclusion: BOR rate at cycle 3, cycle 6, and end of the study lies within the prespecified limit for noninferiority which concludes that test product is therapeutically noninferior to reference medicinal product.
ISSN:0971-5851

Similar Items