JPRN-jRCT2080222236
Unknown
Phase 2
Japanese Phase II Study of Rituximab in combination with FC-chemotherapy in patients with previously untreated Chronic Lymphocytic Leukemia
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- ZENYAKU KOGYO CO., LTD.
- Enrollment
- 6
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •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.
Outcomes
Primary Outcomes
Not specified
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