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IRCT201305296302N5 IRCT 2013-06-07 AryoGen Biopharma company A comparative study between Zitux (Rituximab manufactured by AryoGen) and Mabthera on patients with chronic lymphocytic leukemia (CLL) A comparative study for efficacy and safety between Zitux (Rituximab manufactured by AryoGen) and Mabthera on patients with chronic lymphocytic leukemia (CLL) 2013-08-09 anticipated 78 Complete https://irct.ir/trial/6754 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment. 3 chronic lymphocytic lukemia. Intervention 1: intervention group: combination therapy with (Fludarabine, Cyclophosphamide, Zitux) for 4 cycle with 28 days intervals as below: first treatment cycle: Zitux: 375 mg/m2 IV in first day Fludarabine: 25 mg/m2 IV in second to forth day Cyclophosphamide: 250 mg/m2 IV in second to forth day second to forth treatment cycles: Zitux: 500 mg/m2 IV in first day Fludarabine: 25 mg/m2 IV in first to third day Cyclophosphamide: 250 mg/m2 IV in first to third day. Intervention 2: control group: combination therapy with (Fludarabine, Cyclophosphamide, Reditux) for 4 cycle with 28 days intervals as below: first treatment cycle: Reditux: 375 mg/m2 IV in first day Fludarabine: 25 mg/m2 IV in second to forth day Cyclophosphamide: 250 mg/m2 IV in second to forth day second to forth treatment cycles: Zitux: 500 mg/m2 IV in first day Fludarabine: 25 mg/m2 IV in first to third day Cyclophosphamide: 250 mg/m2 IV in first to third day.
public Dr. Kamran Kamyar
Cross Tajbakhsh Street, 24th Kilometer Makhsous, Tehran - Iran . AryoGen Biopharma Co.
Garmdareh Iran (Islamic Republic of) +98 263610156872 kamyark@aryogen.com AryoGen Biopharma company scientific Dr. Mohammad Faranoush
IBTO bldg, Hemmat Exp.Way, Next to the Milad Tower, Tehran, Iran
tehran Iran (Islamic Republic of) +98 21 8860 5151 faranoush47@gmail.com Iranian Blood Transfusion Organization Iran (Islamic Republic of) inclusion criteria: patient with chronic lymphocytic leukemia according to national cancer institute diagnostic criteria for CLL who hasn't been treated already or is new case of CLL or relapsed/refractory CLL with indication for treatment; Age between 18 to 75; Binet stage disease B,C; ECOG performance status: 0 to 1; CD20 positive; patient has indication for treatment in the beginning of study; written informed consent form. exclusion criteria: Bil>2 mg/dl; Cr> 2 mg/dl; Alk-p> 2 times of upper limit normal; Trans aminase > 2 times of upper limit normal; Coexistence of serious active infection or underlying disorder( Hepatitis B,C, HIV positive, cardiopulmonary disease, recent MI, uncontrolled diabetes or HTN, seizure); HBSAg or HBCAb positive; other cancer treatments in the last 5 years; severe autoimmune hemolytic anemia, pregnancy or breast feeding exclusion criteria: Bil>2 mg/dl; Cr> 2 mg/dl; Alk-p> 2 times of upper limit normal; Trans aminase > 2 times of upper limit normal; Coexistence of serious active infection or underlying disorder( Hepatitis B,C, HIV positive, cardiopulmonary disease, recent MI, uncontrolled diabetes or HTN, seizure); HBSAg or HBCAb positive; other cancer treatments in the last 5 years; severe autoimmune hemolytic anemia, pregnancy or breast feeding 18 years 75 years Both C91.1 Chronic lymphocytic leukaemia of B-cell type Treatment - Drugs Treatment - Drugs intervention group: combination therapy with (Fludarabine, Cyclophosphamide, Zitux) for 4 cycle with 28 days intervals as below: first treatment cycle: Zitux: 375 mg/m2 IV in first day Fludarabine: 25 mg/m2 IV in second to forth day Cyclophosphamide: 250 mg/m2 IV in second to forth day second to forth treatment cycles: Zitux: 500 mg/m2 IV in first day Fludarabine: 25 mg/m2 IV in first to third day Cyclophosphamide: 250 mg/m2 IV in first to third day control group: combination therapy with (Fludarabine, Cyclophosphamide, Reditux) for 4 cycle with 28 days intervals as below: first treatment cycle: Reditux: 375 mg/m2 IV in first day Fludarabine: 25 mg/m2 IV in second to forth day Cyclophosphamide: 250 mg/m2 IV in second to forth day second to forth treatment cycles: Zitux: 500 mg/m2 IV in first day Fludarabine: 25 mg/m2 IV in first to third day Cyclophosphamide: 250 mg/m2 IV in first to third day Overall response rate according to national cancer institute response to treatment criteria. Timepoint: 2 and 4 months after beginning of treatment. Method of measurement: physical exam and laboratoty results according to national cancer institute response to treatment criteria. Complete response rate. Timepoint: 2 and 4 months after beginning of treatment. Method of measurement: physical exam and laboratoty results according to national cancer institute response to treatment criteria. Partial response rate. Timepoint: 2 and 4 months after beginning of treatment. Method of measurement: physical exam and laboratoty results according to national cancer institute response to treatment criteria. Stable disease rate. Timepoint: 2 and 4 months after beginning of treatment. Method of measurement: physical exam and laboratoty results according to national cancer institute response to treatment criteria. Progressive disease rate. Timepoint: 2 and 4 months after beginning of treatment. Method of measurement: physical exam and laboratoty results according to national cancer institute response to treatment criteria. CD20 reduction rate. Timepoint: monthly after beginning of treatment. Method of measurement: flucytometery. Complete response rate according to flucytometery. Timepoint: monthly after beginning of treatment. Method of measurement: flucytometery. Side effect rate, fever. Timepoint: monthly during 4 months of treatment. Method of measurement: physical exam. Side effect rate, cardiovascular. Timepoint: monthly during 4 months of treatment. Method of measurement: physical exam. Side effect rate, digestive. Timepoint: monthly during 4 months of treatment. Method of measurement: physical exam. Side effect rate, hematologic. Timepoint: monthly during 4 months of treatment. Method of measurement: laboratoty results. Side effect rate, metabolic. Timepoint: monthly during 4 months of treatment. Method of measurement: physical exam and laboratoty results. Side effect rate, Musculoskeletal. Timepoint: monthly during 4 months of treatment. Method of measurement: physical exam. Side effect rate, respiratory. Timepoint: monthly during 4 months of treatment. Method of measurement: physical exam. Side effect rate, skin. Timepoint: monthly during 4 months of treatment. Method of measurement: physical exam. AryoGen Biopharma company Approved 2013-03-16 Ethics committee of Iranian Blood Transfusion Organization IBTO bldg, Hemmat Exp.Way, Next to the Milad Tower, Tehran, Iran tehran Iran (Islamic Republic of)