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IRCT201010124920N1 IRCT 2011-08-02 Cinnagen Company A Therapeutic and side effects comparison between Reditux and brand tpe (Mabthera) in Diffuse Large B Cell Lymphoma (DLBCL) A therapeutic and side effects’ comparison between Reditux and brand type (MabThera) in Diffuse Large B Cell Lymphoma (DLBCL) 2011-08-07 anticipated 30 Complete https://irct.ir/trial/5260 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment. N/A Diffuse large B cell lymphoma (DLBCL). Intervention 1: Mabthera (375 mg/m2) every 3 weeks for 6 months (8 courses). Intervention 2: Reditux (375 mg/m2) every 3 weeks for 6 months (8 courses).
public Dr. Sina Salari
Shahid Beheshti University of Medical Sciences, Evin St.
Tehran Iran (Islamic Republic of) 198517413 +98 21 2243 2560 dr.sinasalari@yahoo.com Taleghani Hospital, Shahid Beheshti University of Medical Sciences scientific Dr. Abbas Haji Fath Ali
Shahid Beheshti University of Medical Sciences, Evin St.
Tehran Iran (Islamic Republic of) +98 21 2243 2580 hajifathali@yahoo.com Taleghani Hospital, Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) 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). 18 years 65 years Both C83.3 Diffuse non-Hodgkin's lymphoma, Large cell (diffuse) Treatment - Drugs Treatment - Drugs Mabthera (375 mg/m2) every 3 weeks for 6 months (8 courses) Reditux (375 mg/m2) every 3 weeks for 6 months (8 courses) Radiographic response rate. Timepoint: At the end of quarter and end of treatment. Method of measurement: Radiography ( CT–Scan/ MRI ). 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. Cinnagen Company Approved 2011-07-10 Shahid Beheshti University of Medical Sciences Vice chancellor for research, Shahid Beheshti University of Medical Sciences, Evin, Chamran Highway Tehran Iran (Islamic Republic of)