Health Condition 1: null- CD20-positive diffuse large B-cell or follicular lymphoma
Conditions
Interventions
Intervention1: Rituximab: Rituximab - 375 mg/m2 (IV) BSA for 2 cycles
Control Intervention1: Mabthera: Mabthera- 375 mg/m2 (IV) BSA for 2 cycles
Sponsors
INTAS BIOPHARMACEUTICALS LTD
Oncology Services India Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Inclusion criteria Adult men and women greater or equal to 18 years Patients with histologically confirmed diffuse large B-cell CD20 positive NHL or follicular B-cell Lymphoma Subjects with a performance status of 0 to 2 according to the Eastern Cooperative Oncology Group (ECOG) Normal hematopoietic hepatic and renal function as follows Absolute neutrophil count (ANC) greater than or equal to 1000 per mm3 (unless due to non-Hodgkins lymphoma (NHL) bone marrow involvement) AST ALT less than or equal to 3 multiplied ULN Bilirubin less than or equal 1.5 multiplied ULN Serum creatinine less than 1.5 multiplied ULN Woman of child bearing potential (entering the study after a menstrual period and who have a negative pregnancy test) must agree to use medically acceptable forms of contraception during the study and for three months after the last treatment intake Patients able to understand and voluntarily provide written informed consent before screening following an explanation of the nature and purpose of this study No other serious disease or medical condition that would interfere with compliance
Exclusion criteria
Exclusion criteria: Patients who had prior anti CD20 therapy Hypersensitivity to Rituximab Any other malignancy in the last 2 years other than non-Hodgkins Lymphoma 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 According to investigators opinion patients general status do not permit the administration of CHOP Pregnant or breast-feeding patients (for female patients of child bearing potential) Have received any Investigational product in last 30 days or going to receive any Investigational product during the study period Suspected or confirmed poor compliance according to investigators judgment in completing the trial and follow up
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response rate; Safety endpoints,AE evaluation, anti-rituximab antibody developmentTimepoint: 21 days cycle | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetic assessmentTimepoint: in cycle 1 | — |
Countries
India
Contacts
Public ContactDr Pranjal Bordoloi
IBPL
Outcome results
None listed