Health Condition 1: null- Patients with Non-Hodgkinâ??s Lymphoma
Conditions
Interventions
Intervention1: Rituximab code named R-TPR-017: Dose: 375 mg/m2 intravenous infusions on day 1 of each cycle (21 days) in combination with chemotherapy (CHOP) during induction phase
Duration: up to 2 years
Frequency: Six cycles
Mode of Administration: Intravenous
Control Intervention1: Mabthera® (Ristova®): Dose: 375 mg/m2 intravenous infusions on day 1 of each cycle (21 days) in combination with chemotherapy (CHOP) during
Sponsors
Reliance Life sciences Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Previously untreated patients 2. Histologically confirmed, newly diagnosed follicular B cell Non-Hodgkins lymphoma or diffuse large B cell Non-Hodgkins lymphoma 3. CD20 positive by immunohistochemistry 4. Patients with at least one target lesion (lymph node with short axis of less than or equal to 15 mm by CT scan with contrast) 5. ECOG performance status 0 to 2 6. Life expectancy more than six months 7. Able to comprehend and give informed consent for the study and willing to come for follow up visit as per protocol requirements 8. Consent from Legally Acceptable Representative (LAR), if subject is not in a condition to give consent. However, when the subject is stable and is able to give consent, the consent would be obtained on a separate ICF to confirm his/her willingness to continue participation in the study.
Exclusion criteria
Exclusion criteria: 1. Presence or history of CNS disease (either CNS lymphoma or lymphomatous meningitis) 2. Patients with prior or concomitant malignancy 3. Patients with abnormal laboratory parameters like: • Serum creatinine 2.0 times of upper normal limit • AST or ALT 2.5 times of upper normal limit • Alkaline phosphatase >=1.5 times of upper normal limit • Platelet count 100,000/ZL. • Hemoglobin 8.0 g/dL. • Absolute Neutrophil Count (ANC) 1.5 x 109 /L. • Serum Immunoglobulin G (IgG) level 3.0 g/L 4. History of prior chemotherapy, stem cell transplant and radiotherapy 5. History of high dose, systemic, steroid therapy within 6 weeks 6. Previous use of non-human monoclonal antibody therapy and or known hypersensitive to murine proteins 7. Serious underlying medical condition which could impair the ability of patient to participate in the trial (e.g. Active systemic infection) 8. Severe cardiovascular disease within 12 months including myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, pulmonary embolism, life threatening arrhythmias or uncontrollable hypertension 9. Pregnant or lactating females or women of child-bearing potential, unwilling or unable to use proper contraceptive precautions during the study 10. Subjects with HIV, HBsAg, HCV test positive 11. Subject participation in another clinical trial 30 days prior to administration of IP 12. Any other condition which the Investigator feels would pose a significant hazard to subject if IP is administered
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Proportion of patients with Objective Response Rate {Complete Response and Partial Response} assessed by RECIST 1.1 criteriaTimepoint: At 10 weeks, 24 weeks, 1year, 1.5 year and 2 year | — |
Primary
| Measure | Time frame |
|---|---|
| Efficacy will be assessed as Objective Response Rate (Complete Response and Partial Response) assessed by RECIST 1.1 criteriaTimepoint: at 24 weeks | — |
Countries
India
Contacts
Public ContactDr Parvez Kosgi
Reliance Life Sciences Pvt Ltd
Outcome results
None listed