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

NCT00151736 | Terminated Phase 2

• 1 other identifier: SDX-101-03
• Study Type: interventional
• Target: 88
• Locations: 5 countries
• Sites: 22

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.

Conditions

Chronic Lymphocytic Leukemia

Keywords

Chronic Lymphocytic Leukemia; CLL; Leukemia

Outcome Measures

Primary Outcomes (1)

• Bone Marrow Biopsy or Aspiration

  Overall response rate assessment according to National Cancer Institute-Working Group (NCI-WG) criteria using cytogenetic and biomarker evaluations.

  Baseline + 6 months

Secondary Outcomes (1)

• Cytogenetic and biomarker evaluations + adverse events

  6 months

Study Arms (2)

Chlorambucil

EXPERIMENTAL

Regime A

Drug: Chlorambucil

R-etodolac with chlorambucil

EXPERIMENTAL

Regime B

Drug: R-etodolac + chlorambucil

Interventions

Chlorambucil DRUG

Chlorambucil 2mg tablets

Also known as: SDX-101

Chlorambucil

R-etodolac + chlorambucil DRUG

R-etodolac 600mg tablets + chlorambucil 2mg tablets

R-etodolac with chlorambucil

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• 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.
• No prior chemotherapy for CLL.
• Age ≥ 18 at signing of informed consent.
• World Health Organization (WHO) performance status ≤ 0-2 (Appendix B).
• Platelet count \> 50,000/μL, hemoglobin \> 8.0 g/dl and absolute neutrophil count \> 1000/μL.
• Renal function ≤ 1.5 x upper limit normal (blood urea nitrogen \[BUN\], serum creatinine)

You may not qualify if:

• Active autoimmune manifestation of CLL such as ongoing hemolytic anemia or ITP
• 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.
• Chronic viral infection: positive hepatitis B or hepatitis C serology, known positive for human immunodeficiency virus (HIV) or human T-leukemia/lymphoma virus (HTLV).
• Transformation to an aggressive B-cell malignancy such as Richter's transformation, prolymphocytic leukemia (PLL) or large B-cell lymphoma.
• Clinical evidence of CNS involvement with CLL.
• Serious infection, medical condition, or psychiatric condition that, in the opinion of the investigator, might interfere with the achievement of the study objectives.
• Treatment with any investigational agent within 4 weeks of study entry.
• The use of steroids, nonsteroidal anti-inflammatory drugs, regardless of indication (excluding prophylactic use of aspirin for prevention of acute myocardial infarction or stroke)
• Pregnancy or currently breast feeding.

Sponsors & Collaborators

• Cephalon: lead

Study Sites (22)

Chef du Service d'Hematologie Clinique CHU Clemenceau

Caen, France

Location

Service maladies du sang CHRU- rue Michel Polonovski

Lille, France

Location

Charité - Benjamin Franklin Medizinische Klinik III Hämatologie, Onkologie und Transfusionsmedizin

Berlin, Germany

Location

Internistische Schwerpunktpraxis

Erlangen, Germany

Location

Medizinische Poliklinik der Universität Hämatologie/Onkologie

Würzburg, Germany

Location

Samodzielny Publiczny Szpital Kliniczny AM Klinika Hematologii

Bialystok, Poland

Location

Samodzielny Publiczny Szpital Kliniczny Nr 1 Akademickie Centrum Kliniczne Akdemii Medycznej w Gdansku Klinika Hematologii

Gdansk, Poland

Location

Uniwersytet Jagiellonski Collegium Medicum Katedra i Klinika Hematologii

Krakow, Poland

Location

Wojewodzki Szpital Specjalistyczny im. M. Kopernika, Klinika Hematologii Instytutu Medycyny Wewnetrznej Uniwersytetu Medycznego w Lodzi

Lodz, Poland

Location

Prywatna Praktyka Lekarska z Osrodkiem Badan Klinicznych Prof. L. Szczepanskiego

Lublin, Poland

Location

Samodzielny Publiczny Centralny Szpital Kliniczny Katedra i Klinika Hematologii Onkologii i Chorob Wewnetrznych AM

Warsaw, Poland

Location

Samodzielny Publiczny Szpital Kliniczny Nr 1 Klinika Hematologii, Nowotworow Krwi i Transplantacji Szpiku

Wroclaw, Poland

Location

Centrum för Hematologi Karolinska Universitetssjukhuset, Solna

Stockholm, Sweden

Location

Hematologkliniken Karolinska Universitetssjukhuset, Huddinge

Stockholm, Sweden

Location

Hematologkliniken Norrlands Universitetssjukhus

Umeå, Sweden

Location

Hematologisektionen Medicincentrum Akademiska sjukhuset

Uppsala, Sweden

Location

Royal Bournemouth Hospital Dept. of Haematology

Bournemouth, United Kingdom

Location

Cardiff and Vale NHS Trust University Hospital of Wales

Cardiff, United Kingdom

Location

Stobhill Hospital Department of Haematology

Glasgow, United Kingdom

Location

Leeds General Infirmary Department of Haematology

Leeds, United Kingdom

Location

Leicester Royal Infirmary Department of Oncology & Haematology

Leicester, United Kingdom

Location

Nottingham City Hospital NHS Trust

Nottingham, United Kingdom

Location

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell; Leukemia

Interventions

Chlorambucil

Condition Hierarchy (Ancestors)

Leukemia, B-Cell; Leukemia, Lymphoid; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2005
• First Posted: September 9, 2005
• Study Start: September 1, 2004
• Primary Completion: February 1, 2006
• Study Completion: February 1, 2008
• Last Updated: June 11, 2012

Record last verified: 2012-06

Locations

GB (6); PL (7); FR (2); DE (3); SE (4)