chronic lymphocytic lukemia. Chronic lymphocytic leukaemia of B-cell type
Conditions
Interventions
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 da
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
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:
Sponsors
AryoGen Biopharma company
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
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
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactDr. Kamran Kamyar
AryoGen Biopharma company
Outcome results
None listed