Chronic Lymphocytic Leukemia (CLL)
Conditions
Interventions
Product Name: R-etodolac
Product Code: SDX-101
Pharmaceutical Form: Tablet
INN or Proposed INN: --
CAS Number: 41340-25-4
Current Sponsor code: SDX-101
Other descriptive name: R-etodolac
Concentration
Sponsors
Cephalon UK Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. 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. 2. 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: •Disease related B symptoms (Fever > 38C [100.5F] for = 2 weeks without evidence of infection, night sweats without evidence of infection, weight loss > 10% within previous 6 mo.). •Evidence of progressive marrow failure as manifested by: •A decrease in hemoglobin to 50% over a 2 month period, or an anticipated doubling time of 10 cm in longest diameter) or progressive lymphadenopathy. •Progressive splenomegaly to > 2cm below the left costal margin or other organomegaly with progressive increase over 2 consecutive clinical visits = 2 weeks apart. 3.No prior chemotherapy for CLL. 4.Age = 18 at signing of informed consent. 5.World Health Organization (WHO) performance status 0-2. 6.Platelet count > 50,000/µL, hemoglobin > 8.0 g/dl and absolute neutrophil count > 1000/µL. 7.Renal function = 1.5 x upper limit normal (blood urea nitrogen [BUN], serum creatinine) 8.Liver function = 1.5 times upper limit of normal (total bilirubin, SGOT (AST) and SGPT (ALT) values). 9.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. 10.Signed EC/IRB-approved informed consent by patient prior to all study related procedures. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1.Active autoimmune manifestation of CLL such as ongoing hemolytic anemia or ITP 2.History of a second malignancy with the exception of cervical cancer,or resected basal cell carcinoma or other malignancies with no evidence of recurrence 5 or more years since diagnosis. 3.Chronic viral infection: positive hepatitis B or hepatitis C serology, known positive for human immunodeficiency virus (HIV) or human T-leukemia/lymphoma virus (HTLV). 4.Transformation to an aggressive B-cell malignancy such as Richter’s transformation, prolymphocytic leukemia (PLL) or large B-cell lymphoma. 5.Clinical evidence of CNS involvement with CLL. 6.Serious infection, medical condition, or psychiatric condition that, in the opinion of the investigator, might interfere with the achievement of the study objectives. 7.Treatment with any investigational agent within 4 weeks of study entry. 8.The use of steroids, nonsteriodal anti-inflammatory drugs, regardless of indication (excluding prophylactic use of aspirin for prevention of acute myocardial infarction or stroke) 9.Pregnancy or currently breast feeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the overall response rate (Complete Response and Partial Response) of patients receiving chlorambucil with or without SDX-101 for the treatment of CLL.;Secondary Objective: •To characterize the safety and tolerability of SDX-101 when given in combination with chlorambucil, and chlorambucil alone, for the treatment of CLL. •To determine time to response, duration of response, time to progression for responders, and progression-free survival for patients receiving SDX-101 in combination with chlorambucil or chlorambucil alone. •To describe the cytogenetic profile of patients enrolled in this study and any treatment related response trends such profiles may predict. •To describe the pharmacodynamic impact of SDX-101, as monotherapy and in combination with chlorambucil, on apoptotic biologic markers in patients who have CLL. ;Primary end point(s): The overall response rate (Complete Response and Partial Response) of patients receiving chlorambucil with or without SDX-101 for the treatment of CLL. | — |
Countries
Sweden
Outcome results
None listed