A Randomized, Multi-Center, Phase II Study to Investigate the Safety and Efficacy of SDX-101 (R-etodolac) in Combination with Chlorambucil, and that of Chlorambucil alone, in Patients with Chronic Lymphocytic Leukemia (CLL) - --

• Register: EUCTR
• Last refreshed on: 19 March 2012
• Main ID: EUCTR2004-000440-24-SE
• Date of registration: 08/06/2004
• Prospective Registration: Yes
• Primary sponsor: Cephalon UK Limited
• Public title: A Randomized, Multi-Center, Phase II Study to Investigate the Safety and Efficacy of SDX-101 (R-etodolac) in Combination with Chlorambucil, and that of Chlorambucil alone, in Patients with Chronic Lymphocytic Leukemia (CLL) - --
• Scientific title: A Randomized, Multi-Center, Phase II Study to Investigate the Safety and Efficacy of SDX-101 (R-etodolac) in Combination with Chlorambucil, and that of Chlorambucil alone, in Patients with Chronic Lymphocytic Leukemia (CLL) - --
• Date of first enrolment: 24/08/2004
• Target sample size: 80
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2004-000440-24
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no

Countries of recruitment

Sweden

Key inclusion & exclusion 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 < 10g/dL, or
•A decrease in platelet count to < 100 x 10 9 /L within the previous 6 months, or
•A decrease in absolute neutrophil count (ANC) to < 1.0 x 10 9/L within 6 months
•Progressive lymphocytosis with an increase of > 50% over a 2 month period, or an anticipated doubling time of < 12 months.
•Massive nodes or clusters(i.e., > 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:
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



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Chronic Lymphocytic Leukemia (CLL)

Intervention(s)

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 unit: mg milligram(s)
Concentration type: equal
Concentration number: 600-

Trade Name: Leukeran
Product Name: Chlorambucil
Product Code: -
Pharmaceutical Form: Tablet
INN or Proposed INN: Chlorambucil
CAS Number: 305-03-3
Current Sponsor code: -
Other descriptive name: -
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 2-

Primary Outcome(s)

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.

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.

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.

Secondary ID(s)

SDX-101-03