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LeukemiaPhase 3NCT00043134

Low-Dose Decitabine Compared With Standard Supportive Care in Treating Older Patients With Myelodysplastic Syndrome

A Phase 3 study testing decitabine in people with Leukemia and Myelodysplastic Syndromes, run by European Organisation for Research and Treatment of Cancer - EORTC at 46 sites in 10 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

RATIONALE: Decitabine may help myelodysplasia cells develop into normal stem cells. It is not yet known if decitabine is more effective than standard supportive care in treating myelodysplastic syndrome. Read more about this study

Who is it for?
Ages 60 years and older
What is being tested?
decitabine
How many people
220 participants
Where
46 sitesin 10 countries
Study dates
May 2002to May 2008
Phase
Phase 3
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 60 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

DISEASE CHARACTERISTICS:

  • Diagnosis of primary or secondary myelodysplastic syndromes (MDS)
  • Any FAB or WHO criteria cellular type allowed
  • Bone marrow blast count on aspiration or biopsy of 1 of the following:
  • No more than 10% with poor cytogenetic risk factors (defined as any numerical or structural abnormality of chromosome 7 and/or complex abnormalities)
  • 11-20%
  • 21-30% for patients with acute myeloid leukemia (AML) secondary to MDS (i.e., refractory anemia with excess blasts in transformation by FAB classification)
  • Patients who failed the cytogenetic exam are allowed provided bone marrow blasts are at least 5% and/or 2-3 cytopenias are present
  • No rapid progression towards full-blown AML
  • No blast crisis of chronic myeloid leukemia
  • No t(8;21) alone or in combination with other abnormalities
  • Ineligible for intensive chemotherapy (e.g., cytarabine or an anthracycline)

PATIENT CHARACTERISTICS:

Age

  • 60 and over

Performance status

  • WHO 0-2

Life expectancy

  • Not specified

Hematopoietic

  • See Disease Characteristics

Hepatic

  • Bilirubin less than 1.5 times upper limit of normal (ULN)
  • Hepatitis B surface antigen negative

Renal

  • Creatinine less than 1.5 times ULN

Cardiovascular

  • No severe cardiovascular disease
  • No arrhythmias requiring chronic treatment
  • No congestive heart failure
  • No New York Heart Association class III or IV heart disease
  • No symptomatic ischemic heart disease

Other

  • HIV negative
  • No active uncontrolled infection
  • No other malignancy within the past 3 years except basal cell or squamous cell skin cancer or carcinoma in situ of the cervix within the past 2 years
  • No prior or concurrent evidence of CNS or psychiatric disorders requiring hospitalization
  • No psychological, familial, sociological, or geographical condition that would preclude study

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • More than 6 weeks since prior growth factors for primary MDS
  • No concurrent antiangiogenic drugs (e.g., thalidomide)
  • No concurrent interleukin, interferon, or anti-thymocyte globulin

Chemotherapy

  • See Disease Characteristics
  • More than 6 weeks since prior hydroxyurea for primary MDS
  • No other prior chemotherapy for MDS or AML
  • Prior chemotherapy for solid tumors or lymphoma (resulting in secondary MDS) allowed

Endocrine therapy

  • No concurrent steroids (except as inhalation therapy)

Radiotherapy

  • Prior radiotherapy for solid tumors or lymphoma (resulting in secondary MDS) allowed

Surgery

  • Not specified

Other

  • More than 6 weeks since prior immunosuppressive agents for primary MDS
  • No concurrent amifostine
  • No concurrent cyclosporine
  • No other concurrent experimental therapies

Trial locations and contacts

46 sites in 10 countries.

46 sites in 10 countries

Germany24 sites

  • Charite University Hospital - Campus Virchow Klinikum

    Berlin, D-13353

  • Staedtisches Klinikum Braunschweig

    Braunschweig, G-38114

  • DIAKO Ev. Diakonie Krankenhaus gGmbH

    Bremen, 28239

  • Universitatsklinikum Carl Gustav Carus

    Dresden, D-01307

  • St. Johannes Hospital - Medical Klinik II

    Duisburg, D-47166

  • St. Antonius Hospital

    Eschweiler, DOH-52249

  • Klinikum der J.W. Goethe Universitaet

    Frankfurt, D-60590

  • Universitaetsklinikum Freiburg

    Freiburg im Breisgau, D-79106

  • Klinikum der Albert - Ludwigs - Universitaet Freiburg

    Freiburg im Breisgau, DOH-79104

  • Klinik Fuer Innere Medizin, Hematology/Oncology, Ernst Moritz Armdt Universitaet

    Greifswald, D-17487

  • Medizinische Hochschule Hannover

    Hanover, D-30625

  • Ruprecht - Karls - Universitaet Heidelberg

    Heidelberg, D-69117

  • Universitaetsklinikum des Saarlandes

    Homburg, D-66421

  • Westpfalz-Klinikum GmbH

    Kaiserslautern, D-67653

  • Onkologische Schwerpunktpraxis - Leer

    Leer, D-26789

  • Sana Kliniken Luebeck

    Lübeck, 23560

  • Kreiskrankenhaus Luedenscheid

    Lüdenscheid, 58515

  • Klinikum der Universitaet Muenchen - Grosshadern Campus

    Munich, D-81377

  • Staedtisches Krankenhaus Muenchen - Harlaching

    Munich, D-81545

  • Klinikum Rechts Der Isar - Technische Universitaet Muenchen

    Munich, D-81675

  • Robert-Bosch-Krankenhaus

    Stuttgart, D-70376

  • Southwest German Cancer Center at Eberhard-Karls-University

    Tübingen, D-72076

  • Klinikum Der Stadt Villingen - Schwenningen

    Villingen-Schwenningen, D-78054

  • Medizinische Poliklinik, Universitaet Wuerzburg

    Würzburg, D-97070

Other trials in Germany

Italy5 sites

  • Universita Degli Studi di Florence - Policlinico di Careggi

    Florence, 50134

  • Azienda Ospedaliera Vito Fazzi

    Lecce, 73100

  • Azienda Ospedale - d S. Salvatore

    Pesaro, I-61100

  • Istituto Regina Elena

    Rome, 00161

  • Policlinico A. Gemelli - Universita Cattolica del Sacro Cuore

    Rome, 00168

Other trials in Italy

Netherlands5 sites

  • Onze Lieve Vrouwe Gasthuis

    Amsterdam, 1091 HA

  • Leiden University Medical Center

    Leiden, 2300 CA

  • Academisch Ziekenhuis Maastricht

    Maastricht, 6202 AZ

  • Universitair Medisch Centrum St. Radboud - Nijmegen

    Nijmegen, NL-6500 HB

  • HagaZiekenhuis - Locatie Leyenburg

    The Hague, 2545 CH

Other trials in Netherlands

Belgium4 sites

  • Institut Jules Bordet

    Brussels, 1000

  • U.Z. Gasthuisberg

    Leuven, B-3000

  • H. Hartziekenhuis - Roeselaere.

    Roeselare, 8800

  • Centre Hospitalier Peltzer-La Tourelle

    Verviers, B-4800

Other trials in Belgium

Austria2 sites

  • Innsbruck Universitaetsklinik

    Innsbruck, A-6020

  • St. Johanns-Spital

    Salzburg, A-5020

Other trials in Austria

Czechia2 sites

  • First Medical Clinic of Charles University Hospital

    Prague, 128 08

  • Institute of Hematology and Blood Transfusion

    Prague, 128 20

Other trials in Czechia

Croatia1 site

  • University Hospital Rebro

    Zagreb, 41000

Other trials in Croatia

Switzerland1 site

  • Kantonsspital - Abteilung Onkologie

    Basel, 4031

Other trials in Switzerland

Turkey (Türkiye)1 site

  • Ibn-i Sina Hospital

    Ankara, 06100

Other trials in Turkey (Türkiye)

United Kingdom1 site

  • Royal South Hants Hospital

    Southampton, England, SO14 0YG

Other trials in United Kingdom

About this study

Official title: Intravenous Low-Dose Decitabine Versus Supportive Care in Elderly Patients With Primary Myelodysplastic Syndrome (MDS) (>10% Blasts or High-Risk Cytogenetics), Secondary MDS or Chronic Myelomonocytic Leukemia (CMML) Who Are Not Eligible for Intensive Therapy: An EORTC-German MDS Study Group Randomized Phase III Study

RATIONALE: Decitabine may help myelodysplasia cells develop into normal stem cells. It is not yet known if decitabine is more effective than standard supportive care in treating myelodysplastic syndrome.

PURPOSE: Randomized phase III trial to compare the effectiveness of low-dose decitabine with that of standard supportive care in treating older patients who have myelodysplastic syndrome.

Read the detailed description

OBJECTIVES:

  • Compare the efficacy of low-dose decitabine vs standard supportive care, in terms of overall survival, of elderly patients with myelodysplastic syndromes.
  • Compare the response rate and progression-free survival of patients treated with these regimens.
  • Determine the toxicity of decitabine in these patients.
  • Assess the duration of hospitalization and number of blood transfusions in patients treated with these regimens.
  • Assess the quality of life of patients treated with these regimens.

OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to cytogenetic risk factors (good vs poor vs intermediate vs unknown), disease (primary myelodysplastic syndrome (MDS) vs secondary MDS), and participating center. Patients with a successful cytogenetic exam are also stratified according to overall International Prognostic Scoring System score (intermediate 1 vs intermediate 2 vs high risk). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive decitabine IV over 4 hours every 8 hours for 3 days. Treatment repeats every 6 weeks for 4-8 courses in the absence of disease progression or unacceptable toxicity.
  • Arm II: Patients receive standard supportive care. Quality of life is assessed at baseline, every 6 weeks during therapy, every 2 months for 1 year, and then every 3 months thereafter.

Patients are followed every 2 months for 1 year and then every 3 months thereafter.

PROJECTED ACCRUAL: A total of 220 patients (110 per treatment arm) will be accrued for this study within 2 years.

Being tested
decitabine
Keywords
chronic myelomonocytic leukemia, de novo myelodysplastic syndromes, previously treated myelodysplastic syndromes, refractory anemia, refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, refractory anemia with ringed sideroblasts, refractory cytopenia with multilineage dysplasia, secondary myelodysplastic syndromes, atypical chronic myeloid leukemia, BCR-ABL negative, myelodysplastic/myeloproliferative neoplasm, unclassifiable
Medical subject headings
Leukemia, Myelodysplastic Syndromes, Myelodysplastic-Myeloproliferative Diseases, Leukemia, Myelomonocytic, Chronic, Anemia, Refractory, Anemia, Refractory, with Excess of Blasts, Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative, Myeloproliferative Disorders

What participants receive

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

What is being measured

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

  1. Duration of overall survival

Secondary outcomes (5)

  1. Best response rate as measured by Cheson response criteria

  2. Overall progression-free survival

  3. Toxicity as assessed by CTC v2.0

  4. Quality of life as assessed by EORTC QLQ30

  5. Days in Hospital

Timeline

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

  1. First posted27 Jan 2003 (estimated)
  2. Study startMay 2002
  3. Primary completionMay 2008 (estimated)

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 3
Primary purpose
Treatment
Allocation
Randomised
Masking
None (open label)
Enrolment
220 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00043134
Sponsor's protocol ID
CDR0000256224
Other IDs
EORTC-06011, SUPERGEN-EORTC-06011, GMDSG-EORTC-06011, EudraCT-2005-002830
Status last verified
Apr 2008
First submitted
5 Aug 2002
Last updated
13 Apr 2010
Results posted
No

Publications

  • WijerMans P, Suciu S, Baila L, et al.: Low dose decitabine versus best supportive sare in elderly patients with intermediate or high risk MDS not eligible for intensive chemotherapy: final results of the randomizedpPhase III study (06011) of the EORTC Leukemia and German MDS Study Groups. [Abstract] Blood 112 (11): A-226, 2008.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing decitabine in people with Leukemia and Myelodysplastic Syndromes, run by European Organisation for Research and Treatment of Cancer - EORTC at 46 sites in 10 countries.

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

Who may be eligible to take part?

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: status not confirmed, as of the sponsor's last update on 13 Apr 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 46 sites in Germany, Italy, Netherlands, Belgium, Austria and 5 more countries. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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

Are results available for this study?

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?

Duration of overall survival. 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 NCT00043134, which also lists 1 linked publication.

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 13 Apr 2010; AzTrials last refreshed its copy on 26 Oct 2026.

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