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

Phase 2

• Conditions: Chronic lymphocytic leukemia

• Registration Number: JPRN-jRCT2080222236
• Lead Sponsor: ZENYAKU KOGYO CO., LTD.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-09-30
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Sex: All
• Target Recruitment: 6

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified