Spots Global Cancer Trial Database for Safety and Efficacy of SDX-101 (R-Etodolac) in Combination With Chlorambucil, and That of Chlorambucil Alone, in Patients With Chronic Lymphocytic Leukemia (CLL)
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Trial Identification
Brief Title: Safety and Efficacy of SDX-101 (R-Etodolac) in Combination With Chlorambucil, and That of Chlorambucil Alone, in Patients With Chronic Lymphocytic Leukemia (CLL)
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 ID: NCT00151736
Conditions
Study Description
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.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
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
Contact Details
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