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

NCT ID: NCT00151736

Last Updated: 2012-06-11

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 88 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-09-30
• Study Completion Date: 2008-02-29

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Chlorambucil

Regime A

Group Type: EXPERIMENTAL

Chlorambucil

Intervention Type: DRUG

Chlorambucil 2mg tablets

R-etodolac with chlorambucil

Regime B

Group Type: EXPERIMENTAL

R-etodolac + chlorambucil

Intervention Type: DRUG

R-etodolac 600mg tablets + chlorambucil 2mg tablets

Interventions

Chlorambucil

Chlorambucil 2mg tablets

Intervention Type: DRUG

R-etodolac + chlorambucil

R-etodolac 600mg tablets + chlorambucil 2mg tablets

Intervention Type: DRUG

Other Intervention Names

SDX-101

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cephalon

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

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

Warsaw, , 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

Countries

France; Germany; Poland; Sweden; United Kingdom

Other Identifiers

SDX-101-03

Identifier Type: -

Identifier Source: org_study_id