A study of Rituximab in patients with Non Hodgkins Lymphoma a type of cancer
- Conditions
- Health Condition 1: null- CD20-positive diffuse large B-cell or follicular lymphomaNHL patients
- Registration Number
- CTRI/2012/03/002502
- Lead Sponsor
- INTAS BIOPHARMACEUTICALS LTD
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 100
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Objective Response rate; Safety endpoints,AE evaluation, anti-rituximab antibody developmentTimepoint: 21 days cycle
- Secondary Outcome Measures
Name Time Method Pharmacokinetic assessmentTimepoint: in cycle 1