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This is a Phase 2, multi-center, open label, randomized clinical study to evaluate the safety and efficiency of SDX-101 in combination with chlorambucil (CLB) and chlorambucil alone in Chronic Lymphocytic Leukaemia (CLL) patients. The study treatment period will be approximately 24-26 weeks with a follow-up period of approximately 8 weeks. Following the end of treatment, patients with a confirmed complete response, partial response or stable disease will be followed for up to 2 years to assess time to disease progression. Approximately 80 patients with documented diagnosis of B-cell CLL by standard clinical and immunophenotyping criteria will be enrolled into the SDX-101-03 study. This study is being conducted in the following European countries: France, Germany, Poland, Sweden and the United Kingdom.
Enrollment
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Inclusion criteria
Diagnosis of B-cell CLL by standard clinical and immunophenotypic criteria as specified by the NCI working group revised guidelines for diagnosis and treatment of CLL(32).
Binet stages A-C with evidence of active disease requiring treatment by the presence of one or more of the following at the time of study entry:
No prior chemotherapy for CLL.
Age ≥ 18 at signing of informed consent.
World Health Organization (WHO) performance status ≤ 0-2 (Appendix B).
Platelet count > 50,000/μL, hemoglobin > 8.0 g/dl and absolute neutrophil count > 1000/μL.
Renal function ≤ 1.5 x upper limit normal (blood urea nitrogen [BUN], serum creatinine)
Liver function ≤ 1.5 times upper limit of normal (total bilirubin, SGOT (AST) and SGPT (ALT) values).
Female patients of childbearing potential must have a negative pregnancy test (serum or urine Beta-human chorionic gonadotropin, Beta-HCG); men and women of reproductive potential must employ effective contraceptive methods while on study therapy, and for 2 months following completion of treatment.
Signed EC/IRB-approved informed consent by patient prior to all study related procedures.
Exclusion criteria
Primary purpose
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88 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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