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

NCT ID: NCT00043134

Last Updated: 2010-04-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 220 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-05-31

Brief 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.

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.

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.

Conditions

Leukemia; Myelodysplastic Syndromes; Myelodysplastic/Myeloproliferative Neoplasms

Study Design

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

Interventions

decitabine

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

European Organisation for Research and Treatment of Cancer - EORTC

NETWORK

Sponsor Role: lead

Principal Investigators

Pierre W. Wijermans, MD, PhD

Role:

HagaZiekenhuis - Locatie Leyenburg

Michael Luebbert, MD

Role:

University Hospital Freiburg

Locations

Innsbruck Universitaetsklinik

Innsbruck, , Austria

St. Johanns-Spital

Salzburg, , Austria

Institut Jules Bordet

Brussels, , Belgium

U.Z. Gasthuisberg

Leuven, , Belgium

H. Hartziekenhuis - Roeselaere.

Roeselare, , Belgium

Centre Hospitalier Peltzer-La Tourelle

Verviers, , Belgium

University Hospital Rebro

Zagreb, , Croatia

First Medical Clinic of Charles University Hospital

Prague, , Czechia

Institute of Hematology and Blood Transfusion

Prague, , Czechia

Charite University Hospital - Campus Virchow Klinikum

Berlin, , Germany

Staedtisches Klinikum Braunschweig

Braunschweig, , Germany

DIAKO Ev. Diakonie Krankenhaus gGmbH

Bremen, , Germany

Universitatsklinikum Carl Gustav Carus

Dresden, , Germany

St. Johannes Hospital - Medical Klinik II

Duisburg, , Germany

St. Antonius Hospital

Eschweiler, , Germany

Klinikum der J.W. Goethe Universitaet

Frankfurt, , Germany

Universitaetsklinikum Freiburg

Freiburg im Breisgau, , Germany

Klinikum der Albert - Ludwigs - Universitaet Freiburg

Freiburg im Breisgau, , Germany

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

Greifswald, , Germany

Medizinische Hochschule Hannover

Hanover, , Germany

Ruprecht - Karls - Universitaet Heidelberg

Heidelberg, , Germany

Universitaetsklinikum des Saarlandes

Homburg, , Germany

Westpfalz-Klinikum GmbH

Kaiserslautern, , Germany

Onkologische Schwerpunktpraxis - Leer

Leer, , Germany

Sana Kliniken Luebeck

Lübeck, , Germany

Kreiskrankenhaus Luedenscheid

Lüdenscheid, , Germany

Klinikum der Universitaet Muenchen - Grosshadern Campus

Munich, , Germany

Staedtisches Krankenhaus Muenchen - Harlaching

Munich, , Germany

Klinikum Rechts Der Isar - Technische Universitaet Muenchen

Munich, , Germany

Robert-Bosch-Krankenhaus

Stuttgart, , Germany

Southwest German Cancer Center at Eberhard-Karls-University

Tübingen, , Germany

Klinikum Der Stadt Villingen - Schwenningen

Villingen-Schwenningen, , Germany

Medizinische Poliklinik, Universitaet Wuerzburg

Würzburg, , Germany

Universita Degli Studi di Florence - Policlinico di Careggi

Florence, , Italy

Azienda Ospedaliera Vito Fazzi

Lecce, , Italy

Azienda Ospedale - d S. Salvatore

Pesaro, , Italy

Istituto Regina Elena

Rome, , Italy

Policlinico A. Gemelli - Universita Cattolica del Sacro Cuore

Rome, , Italy

Onze Lieve Vrouwe Gasthuis

Amsterdam, , Netherlands

Leiden University Medical Center

Leiden, , Netherlands

Academisch Ziekenhuis Maastricht

Maastricht, , Netherlands

Universitair Medisch Centrum St. Radboud - Nijmegen

Nijmegen, , Netherlands

HagaZiekenhuis - Locatie Leyenburg

The Hague, , Netherlands

Kantonsspital - Abteilung Onkologie

Basel, , Switzerland

Ibn-i Sina Hospital

Ankara, , Turkey (Türkiye)

Royal South Hants Hospital

Southampton, England, United Kingdom

Countries

Austria; Belgium; Croatia; Czechia; Germany; Italy; Netherlands; Switzerland; Turkey (Türkiye); United Kingdom

References

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.

Reference Type: RESULT

Other Identifiers

EORTC-06011

Identifier Type: -

Identifier Source: secondary_id

SUPERGEN-EORTC-06011

Identifier Type: -

Identifier Source: secondary_id

GMDSG-EORTC-06011

Identifier Type: -

Identifier Source: secondary_id

EudraCT-2005-002830

Identifier Type: -

Identifier Source: secondary_id

CDR0000256224

Identifier Type: -

Identifier Source: org_study_id