Safety and Efficacy of SDX-101 (R-Etodolac) in Combination With Chlorambucil, and That of Chlorambucil Alone, in Patients With Chronic Lymphocytic Leukemia (CLL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00151736
Recruitment Status : Terminated
First Posted : September 9, 2005
Last Update Posted : June 11, 2012
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( Cephalon )

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Chronic Lymphocytic Leukemia Drug: Chlorambucil Drug: R-etodolac + chlorambucil Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 88 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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)
Study Start Date : September 2004
Actual Primary Completion Date : February 2006
Actual Study Completion Date : February 2008

Arm Intervention/treatment
Experimental: Chlorambucil
Regime A
Drug: Chlorambucil
Chlorambucil 2mg tablets
Other Name: SDX-101

Experimental: R-etodolac with chlorambucil
Regime B
Drug: R-etodolac + chlorambucil
R-etodolac 600mg tablets + chlorambucil 2mg tablets

Primary Outcome Measures :
  1. Bone Marrow Biopsy or Aspiration [ Time Frame: Baseline + 6 months ]
    Overall response rate assessment according to National Cancer Institute-Working Group (NCI-WG) criteria using cytogenetic and biomarker evaluations.

Secondary Outcome Measures :
  1. Cytogenetic and biomarker evaluations + adverse events [ Time Frame: 6 months ]
    Cytogenetic and biomarker evaluations performed on day 14 (for regimen B) and day 1 (for regimen A) to assess Safety and Tolerability. Study visits to assess safety occur every 2 weeks for 3 months, then every month thereafter. Safety assessments include: medical history, physical examinations, vital sign measurements, adverse event assessment, routine hematology and serum chemistry tests, urinalysis, and ECGs.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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(32).
  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 < 6 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 (Appendix B).
  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.

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, nonsteroidal 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00151736

Chef du Service d'Hematologie Clinique CHU Clemenceau
Caen, France
Service maladies du sang CHRU- rue Michel Polonovski
Lille, France
Charité - Benjamin Franklin Medizinische Klinik III Hämatologie, Onkologie und Transfusionsmedizin
Berlin, Germany
Internistische Schwerpunktpraxis
Erlangen, Germany
Medizinische Poliklinik der Universität Hämatologie/Onkologie
Würzburg, Germany
Samodzielny Publiczny Szpital Kliniczny AM Klinika Hematologii
Bialystok, Poland
Samodzielny Publiczny Szpital Kliniczny Nr 1 Akademickie Centrum Kliniczne Akdemii Medycznej w Gdansku Klinika Hematologii
Gdansk, Poland
Uniwersytet Jagiellonski Collegium Medicum Katedra i Klinika Hematologii
Krakow, Poland
Wojewodzki Szpital Specjalistyczny im. M. Kopernika, Klinika Hematologii Instytutu Medycyny Wewnetrznej Uniwersytetu Medycznego w Lodzi
Lodz, Poland
Prywatna Praktyka Lekarska z Osrodkiem Badan Klinicznych Prof. L. Szczepanskiego
Lublin, Poland
Samodzielny Publiczny Centralny Szpital Kliniczny Katedra i Klinika Hematologii Onkologii i Chorob Wewnetrznych AM
Warszawa, Poland
Samodzielny Publiczny Szpital Kliniczny Nr 1 Klinika Hematologii, Nowotworow Krwi i Transplantacji Szpiku
Wroclaw, Poland
Centrum för Hematologi Karolinska Universitetssjukhuset, Solna
Stockholm, Sweden
Hematologkliniken Karolinska Universitetssjukhuset, Huddinge
Stockholm, Sweden
Hematologkliniken Norrlands Universitetssjukhus
Umeå, Sweden
Hematologisektionen Medicincentrum Akademiska sjukhuset
Uppsala, Sweden
United Kingdom
Royal Bournemouth Hospital Dept. of Haematology
Bournemouth, United Kingdom
Cardiff and Vale NHS Trust University Hospital of Wales
Cardiff, United Kingdom
Stobhill Hospital Department of Haematology
Glasgow, United Kingdom
Leeds General Infirmary Department of Haematology
Leeds, United Kingdom
Leicester Royal Infirmary Department of Oncology & Haematology
Leicester, United Kingdom
Nottingham City Hospital NHS Trust
Nottingham, United Kingdom
Sponsors and Collaborators

Responsible Party: Cephalon Identifier: NCT00151736     History of Changes
Other Study ID Numbers: SDX-101-03
First Posted: September 9, 2005    Key Record Dates
Last Update Posted: June 11, 2012
Last Verified: June 2012

Keywords provided by Teva Pharmaceutical Industries ( Cephalon ):
Chronic Lymphocytic Leukemia

Additional relevant MeSH terms:
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents