A comparative study between Zitux (Rituximab manufactured by AryoGen) and Mabthera on patients with chronic lymphocytic leukemia (CLL)

Phase 3

• Conditions: chronic lymphocytic lukemia.; Chronic lymphocytic leukaemia of B-cell type

• Registration Number: IRCT201305296302N5
• Lead Sponsor: AryoGen Biopharma company

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 22 February 2018

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 78

Inclusion Criteria

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.