Japanese Phase II Study of Rituximab in combination with FC-chemotherapy in patients with previously untreated Chronic Lymphocytic Leukemia

Status

Unknown

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080222236

Enrollment

Registered

2013-09-30

Start date

2013-09-30

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic lymphocytic leukemia

Interventions

investigational material(s) Generic name etc : IDEC-C2B8 INN of investigational material : Rituximab (genetical recombination) Therapeutic category code : 429 Other antitumor agents Dosage and Adminis

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion 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.

Exclusion criteria

Exclusion 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.

Design outcomes

Primary

Measure	Time frame
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	—

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026