Safety and efficacy assessment of Rituximab (Zydus) in comparison with Rituximab (Roche/Genentech) in Patients with Diffuse Large B Cell Lymphoma (DLBCL)

Phase 3

Completed

• Conditions: Non-Hodgkin lymphoma, unspecified,

• Registration Number: CTRI/2018/07/014885
• Lead Sponsor: Cadila Healthcare Ltd

Brief Summary

This is Randomized, Assessor-Blind, Multicentre, ParallelGroup, Two Arms, Clinical Study to Assess the Efficacy, Pharmacokinetics,Pharmacodynamics, Immunogenicity and Safety of Rituximab (Test Product, Zydus)in comparison with Rituximab (Reference Product, Roche/Genentech) in Patientswith Diffuse Large B Cell Lymphoma (DLBCL).

Detailed Description

Not available

Study Timeline

• Study Start: 2018-03-09
• Study Completion: 2020-11-30
• Last Update Posted: 2022-09-13

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 153

Inclusion Criteria

• 1.The patient willing to give written, signed, and dated informed consent to participate in the study before initiating any study related procedures 2.Male or non-pregnant, non-lactating Female ≥18 years and ≤65 years of age (both inclusive) 3.Patients with at least one measurable lesion as per International Working Group Revised Response Criteria for Malignant Lymphoma 4.Untreated Newly diagnosed patients with a confirmed pathologic diagnosis of CD20+ large B cell-non-Hodgkin’s lymphoma (DLBCL).
• 5.Stage II-III or IV defined by the referring physician on the basis of the Cotswolds modification of the Ann Arbor classification.
• 6.Age-adjusted International Prognostic Index (IPI) score 0 or 1 7.Patients who are eligible for receiving Rituximab and CHOP 8.Patient must have an adequate bone marrow, renal, cardiac and hepatic function a.Bone marrow reserve: i.ANC ≥ 1500/mm3 ii.Platelet count ≥ 100,000/mm3 iii.Hemoglobin ≥ 9.0 g/dL b.Renal Function: Serum Creatinine ≤ 1.5 times ULN c.Hepatic Function: i.Total bilirubin ≤1.5 × upper limit of normal (ULN); except if elevation is due to Gilbert’s Syndrome with transitory elevations of indirect bilirubin.
• d.Left Ventricular Ejection Fraction (LVEF) ≥50% determined by either ECHO or MUGA Scan 9.Subjects with a performance status of 0 to 2 according to the Eastern Cooperative Oncology Group (ECOG) 10.If capable of reproduction, patients and their partners must use contraceptive methods during the full duration of the study and for 12 months after discontinuation of study.

Exclusion Criteria

• 1.Patient who has a history of hypersensitivity reactions with murine proteins or planned chemotherapy.
• 2.Bulky Disease (>10 cm on maximum dimension) or involves >1/3 of chest diameter (on radiographic imaging) 3.Patient with severely immunocompromised state.
• 4.Patient treated with prior therapies including but not limited to Anthracyclines, Rituximab, any other anti-CD-20 therapy or autologous or allogeneic stem cell transplantation 5.Any radiotherapy given for lymphoma or non-lymphoma before 30 days of randomization 6.Patients depending on systemic steroids for Non Lymphomatous condition 7.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) 8.Patients with an active, severe infection (e.g., tuberculosis, sepsis and opportunistic infections).
• 9.Cardiac contra-indication to Doxorubicin therapy: noncompensated heart failure, dilated cardiomyopathy, coronary heart disease with ST segment depression on electrocardiogram (ECG), myocardial infarction in the last 6 months.
• 10.Neurologic contra-indication to Vincristine as it is indicated in the SmPC: (e.g. peripheral neuropathy).
• 11.Chronic lung disease with hypoxemia (SpO2 Ë‚ 90%).
• 12.Severe uncontrolled hypertension (blood pressure more than 150/100 mm Hg), despite optimal medical treatment.
• 13.Severe uncontrolled diabetes mellitus (As defined by American Diabetes Association), despite optimal medical treatment.
• 14.Major surgery within 4 weeks of study start (i.e., randomisation) 15.Any other malignancy in the last 5 years other than Non-Hodgkin’s Lymphoma except skin cancer or carcinoma in situ of the cervix 16.Known History of drug addiction within last 1 year 17.The receipt of an investigational medicinal product or participation in other drug research study within a period of 30 days prior to the first dose of investigational medicinal product for the current study.
• 18.Any history or presence of clinically significant cardiovascular, respiratory, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic ,neurologic, or psychiatric disease or any other condition which in the opinion of the investigator could jeopardize the safety of the subject or the validity of the study results 19.Receipt of live vaccine within 4 weeks prior to study drug administration 20.Pregnant or breast-feeding patients (for female patients of child bearing potential).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall Response Rate (i.e., CR + PR) by using International Working Group Response Criteria for Malignant Lymphoma	Timeframe: Baseline & at the end of cycle 6

Secondary Outcome Measures

Name	Time	Method
1.Overall Response Rate	2.Assessment of Pharmacokinetic parameters

Trial Locations

Locations (33)

Aadhar health institute; 🇮🇳 Hisar, HARYANA, India

Apex Hospital Private Limited; 🇮🇳 Jaipur, RAJASTHAN, India

Bhakti Vedanta Hospital & Research Institute; 🇮🇳 Thane, MAHARASHTRA, India

Chittaranjan National cancer Institute; 🇮🇳 Kolkata, WEST BENGAL, India

Christian Medical College; 🇮🇳 Vellore, TAMIL NADU, India

Global Abhishek Cancer Hospital & Research Centre; 🇮🇳 Jaipur, RAJASTHAN, India

Global Enterprise; 🇮🇳 Bangalore, KARNATAKA, India

Global Hospital & Research Institute; 🇮🇳 Pune, MAHARASHTRA, India

Government Medical College and Hospital; 🇮🇳 Nagpur, MAHARASHTRA, India

Grant Medical Foundation Ruby Hall Clinic; 🇮🇳 Pune, MAHARASHTRA, India

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Aadhar health institute

🇮🇳Hisar, HARYANA, India

Dr Lovenish Goyal

Principal investigator

9896539142

drlovenish@gmaiil.com