A Therapeutic and side effects comparison between Reditux and brand tpe (Mabthera) in Diffuse Large B Cell Lymphoma (DLBCL)
Not Applicable
- Conditions
- Diffuse large B cell lymphoma (DLBCL).Diffuse non-Hodgkin's lymphoma, Large cell (diffuse)
- Registration Number
- IRCT201010124920N1
- Lead Sponsor
- Cinnagen Company
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 30
Inclusion Criteria
DLBCL patients 18 to 65 years old (male & female); CD 20 marker positivity; Completion of informal consent. Exclusion criteria: Recurrence DLBCL; Systolic dysfunction (EF<50%); HIV, HBV, HCV markers positivity; History of organ transplantation of other active malignancy; History of allergy to monoclonal antibodies; ECOG performance status >3; Advanced Liver or renal dysfunctions (Bil T >6 mg/dl or Cr >4 mg/dl).
Exclusion Criteria
Not provided
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Radiographic response rate. Timepoint: At the end of quarter and end of treatment. Method of measurement: Radiography ( CT–Scan/ MRI ).
- Secondary Outcome Measures
Name Time Method Hematologic response rate, Partial remission and Complete remission. Timepoint: Three weeks (end of treatment), hematologic evaluation is done and the next course of treatment is started. And at the end of the fourth and eighth radiologic evaluation occurs. Method of measurement: The variables measured in blood; through the blood and bone marrow radiological assessment if necessary.