A clinical trial to study the effects of Rituximab injection (Hetero) in Indian patients suffering from varieties of Non-Hodgkins Lymphoma.

Phase 3

Completed

• Conditions: Non-Hodgkin lymphoma, unspecified,

• Registration Number: CTRI/2013/08/003921
• Lead Sponsor: Hetero Drugs Limited

Brief Summary

This study is an open label, randomized, multiple-dose, parallel study to evaluate the safety and efficacy of intravenous infusion of Rituximab Test product (Hetero) and Reference product in two clinical subtypes of Non-Hodgkin’s lymphoma (DLBCL & follicular) given along with CHOP chemotherapy. The primary objective is to compare the antitumor efficacy of Hetero-Rituximab with Reference Medicinal Product (Rituximab, Roche). The secondary objectives are to evaluate safety of the patients, compare the  immunogenic potentials from baseline to the end of 3rd & 6thcycles of chemotherapy, to evaluate the pharmacokinetic characteristics at 1st & 6th cycles of chemotherapy, and compare the pharmacodynamics from baseline to the end of 3rd & 6th cycles of chemotherapy, between two formulations of Rituximab (test and reference).

Detailed Description

Not available

Study Timeline

• Study Start: 2013-08-30
• Last Update Posted: 2021-01-20

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

•The patient willing to give written, signed, and dated informed consent to participate in the study before initiating any study related procedures •Male or Female ≥18 years and ≤65 years of age (both inclusive) •Histologically confirmed CD20-positive- Newly diagnosed diffuse large B-cell Non-Hodgkin’s lymphoma OR Previously untreated patients with stage III-IV follicular lymphoma in combination with chemotherapy •Patients who are eligible for rituximab and CHOP •Patients with at least one measurable lesion as per International Working Group Response Criteria for Malignant Lymphoma •Adequate liver, renal, cardiac and haematological functions •Subjects with a performance status of 0 to 2 according to the Eastern Cooperative Oncology Group (ECOG) •Life expectancy more than six months •No other serious illness that according to investigator might jeopardize the well-being, the safety of study subjects, the compliance to study medications and validity of data generated during the study.

Exclusion Criteria

• Hypersensitivity reactions with murine proteins or planned chemotherapy •Diffuse lymphoma for which CHOP is not adequate therapy •Bulky Disease (10 cm on maximum dimension) or involves 1/3 of chest diameter (on radiographic imaging) •Need for emergency therapy such as neurologic compression syndrome •Subjects with CNS involvement or CNS lymphoma (Diffuse large B-cell lymphoma that is primary CNS, effusional, or intravascular according to the WHO, 2008 classification) •Patient treated with prior chemotherapy including not limited to Anthracyclines, Rituximab, anti-CD-20 therapy or autologous or allogeneic stem cell transplantation •Any radiotherapy given for lymphoma or non-lymphoma before 30 days of planned treatment •Symptomatic peripheral neuropathy (≥Grade 2,Common Terminology Criteria of Adverse Events [CTCAE v 4.03) •Patients using systemic antibiotic therapy 30 days prior to screening.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall Response rate (ORR) by International Working Group (IWG) response criteria	At baseline, end of cycle 3 and 6.

Secondary Outcome Measures

Name	Time	Method
Pharmacodynamics: CD19 counts	Pharmacokinetics:Cmax, Tmax & AUC

Trial Locations

Locations (36)

Acharya Harihar Regional Cancer Centre; 🇮🇳 Cuttack, ORISSA, India

Acharya Tulsi Regional Cancer Treatment & Research Institute; 🇮🇳 Bikaner, RAJASTHAN, India

Apollo Gleneagles Cancer Hospital; 🇮🇳 Kolkata, WEST BENGAL, India

Basavatarakam Indo American Cancer Hospital& Research Institute; 🇮🇳 Hyderabad, ANDHRA PRADESH, India

Batra Hospital & Medical Research Centre; 🇮🇳 Delhi, DELHI, India

BGS Global Hospital; 🇮🇳 Bangalore, KARNATAKA, India

Bhakti Vedanta Hospital; 🇮🇳 Mumbai, MAHARASHTRA, India

BIBI General Hospital and Cancer Center; 🇮🇳 Hyderabad, ANDHRA PRADESH, India

Chittranjan national cancer institute; 🇮🇳 Kolkata, WEST BENGAL, India

City Cancer Centre; 🇮🇳 Krishna, ANDHRA PRADESH, India

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Acharya Harihar Regional Cancer Centre

🇮🇳Cuttack, ORISSA, India

Dr Dipti Rani Samanta MD

Principal investigator

06712303780

diptiranisamanta@rediffmail.com