Safety and Efficacy of SDX-101 (R-Etodolac) in Combination With Chlorambucil, and That of Chlorambucil Alone, in Patients With Chronic Lymphocytic Leukemia (CLL)
Information source: Teva Pharmaceutical Industries
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Chronic Lymphocytic Leukemia
Intervention: Chlorambucil (Drug); R-etodolac + chlorambucil (Drug)
Phase: Phase 2
Status: Terminated
Sponsored by: Cephalon
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.
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Bone Marrow Biopsy or Aspiration
Secondary outcome: Cytogenetic and biomarker evaluations + adverse events
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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(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.
Locations and Contacts
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
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
Additional Information
Starting date: September 2004
Last updated: June 8, 2012
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