NIPH Clinical Trials Search

Basic Information

Recruitment status
Health condition(s) or Problem(s) studied	Chronic lymphocytic leukemia
Date of first enrollment	30/09/2013
Target sample size	6
Countries of recruitment
Study type	Interventional
Intervention(s)	investigational material(s) Generic name etc : IDEC-C2B8 INN of investigational material : Rituximab (genetical recombination) Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational material : Intravenous infusion

Outcome(s)

Primary Outcome	1) Safety - rate of adverse events - rate of adverse drug reactions - rate of serious adverse events - infusion reactions of IDEC-C2B8 2) Response rate of FCR therapy
Secondary Outcome

Key inclusion & exclusion criteria

Age minimum	>= 20age old
Age maximum	Not applicable
Gender	Both
Include criteria	1. B-CLL confirmed according to the updated NCI Working Group criteria. 2. No previous treatment of the CLL by chemotherapy, radiotherapy or immunotherapy. 3. Binet stage C or Binet stage B plus at least one of the signs or symptoms. 4. More than 20 years of age. 5. Life expectancy > 6 months. 6. ECOG performance status 0-1. 7. A negative serum pregnancy test at screening. 8. Alkaline phosphatase and transaminases <= 2 * ULN. 9. Must give written informed consent prior to the study. 10. Willingness to use contraception for the entire duration of the treatment and 2 months thereafter.
Exclude criteria	1. Binet stage A. 2. Clinically significant auto-immune cytopenia, Coombs-positive haemolytic anaemia as judged by the treating physician. 3. Active second malignancy currently requiring treatment (except basal cell carcinoma or tumour treated curatively by surgery). 4. Concomitant disease requiring prolonged use of glucocorticoids (> 1 month). 5. Known hypersensitivity or anaphylactic reaction to any chimeric or humanized monoclonal antibodies. 6. Cumulative Illness Rating Scale (CIRS) score > 6. 7. Cerebral dysfunction which makes it impossible to perform chemotherapy. 8. Transformation to aggressive B-cell malignancy (e.g. diffuse large cell lymphoma, Richter's syndrome, or prolymphocytic leukaemia). 9. Active bacterial, viral or fungal infection. 10. Positive HIV antibody. 11. Positive HBV serology (i.e., HBs antigen, HBs antibody, HBc antibody), and positive HCV antibody within 4 weeks prior to screening. 12. Total bilirubin > 2 * ULN. 13. Creatinine clearance < 70 ml/min. 14. Any coexisting medical or psychological condition that would preclude participation in the required study procedures. 15. Patients previously treated with rasburicase. 16. Pregnancy, and/or nursing. 17. Patients who have received other investigational drug at screening.