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Chronic Lymphocytic LeukemiaPhase 2NCT00151736

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

A Phase 2 study testing Chlorambucil and R-etodolac + chlorambucil in people with Chronic Lymphocytic Leukemia, run by Cephalon at 22 sites in 5 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Lymphocytic Leukemia
What is being tested?
Chlorambucil and R-etodolac + chlorambucil
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
88 participants
Where
22 sitesin 5 countries
Study dates
Sep 2004to Feb 2008
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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)
  • Liver function ≤ 1.5 times upper limit of normal (total bilirubin, SGOT (AST) and SGPT (ALT) values).
  • 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.
  • Signed EC/IRB-approved informed consent by patient prior to all study related procedures.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

22 sites in 5 countries.

22 sites in 5 countries

Poland7 sites

  • Samodzielny Publiczny Szpital Kliniczny AM Klinika Hematologii

    Bialystok

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

    Gdansk

  • Uniwersytet Jagiellonski Collegium Medicum Katedra i Klinika Hematologii

    Krakow

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

    Lodz

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

    Lublin

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

    Warsaw

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

    Wroclaw

Other trials in Poland

United Kingdom6 sites

  • Royal Bournemouth Hospital Dept. of Haematology

    Bournemouth

  • Cardiff and Vale NHS Trust University Hospital of Wales

    Cardiff

  • Stobhill Hospital Department of Haematology

    Glasgow

  • Leeds General Infirmary Department of Haematology

    Leeds

  • Leicester Royal Infirmary Department of Oncology & Haematology

    Leicester

  • Nottingham City Hospital NHS Trust

    Nottingham

Other trials in United Kingdom

Sweden4 sites

  • Centrum för Hematologi Karolinska Universitetssjukhuset, Solna

    Stockholm

  • Hematologkliniken Karolinska Universitetssjukhuset, Huddinge

    Stockholm

  • Hematologkliniken Norrlands Universitetssjukhus

    Umeå

  • Hematologisektionen Medicincentrum Akademiska sjukhuset

    Uppsala

Other trials in Sweden

Germany3 sites

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

    Berlin

  • Internistische Schwerpunktpraxis

    Erlangen

  • Medizinische Poliklinik der Universität Hämatologie/Onkologie

    Würzburg

Other trials in Germany

France2 sites

  • Chef du Service d'Hematologie Clinique CHU Clemenceau

    Caen

  • Service maladies du sang CHRU- rue Michel Polonovski

    Lille

Other trials in France

About this study

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)

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.

Being tested
Chlorambucil, R-etodolac + chlorambucil
Keywords
Chronic Lymphocytic Leukemia, CLL, Leukemia
Medical subject headings
Leukemia, Lymphocytic, Chronic, B-Cell, Leukemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ChlorambucilDrug

    Also called SDX-101

    Chlorambucil 2mg tablets

  • R-etodolac + chlorambucilDrug

    R-etodolac 600mg tablets + chlorambucil 2mg tablets

Study groups in NCT00151736
Study groupRoleWhat they receive
ChlorambucilExperimentalRegime A
Receives: Drug: Chlorambucil
R-etodolac with chlorambucilExperimentalRegime B
Receives: Drug: R-etodolac + chlorambucil

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline + 6 months

Secondary outcomes (1)

  1. Cytogenetic and biomarker evaluations + adverse events

    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.

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Sep 2005 (estimated)
  2. Study startSep 2004
  3. Primary completionFeb 2006
  4. Study completionFeb 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
88 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00151736
Sponsor's protocol ID
SDX-101-03
Status last verified
Jun 2012
First submitted
7 Sep 2005
Last updated
11 Jun 2012
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Chlorambucil and R-etodolac + chlorambucil in people with Chronic Lymphocytic Leukemia, run by Cephalon at 22 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 11 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 22 sites in Poland, United Kingdom, Sweden, Germany, France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early. Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Bone Marrow Biopsy or Aspiration (time frame: Baseline + 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00151736.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2012.

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