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

NCT00043134 | Unknown Phase 3

• 5 other identifiers: CDR0000256224EORTC-06011SUPERGEN-EORTC-06011GMDSG-EORTC-06011EudraCT-2005-002830
• Study Type: interventional
• Target: 220
• Locations: 10 countries
• Sites: 46

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.

Conditions

Leukemia; Myelodysplastic Syndromes; Myelodysplastic/Myeloproliferative Neoplasms

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

Outcome Measures

Primary Outcomes (1)

• Duration of overall survival

Secondary Outcomes (5)

• Best response rate as measured by Cheson response criteria

• Overall progression-free survival

• Toxicity as assessed by CTC v2.0

• Quality of life as assessed by EORTC QLQ30

• Days in Hospital

Interventions

decitabine DRUG

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• European Organisation for Research and Treatment of Cancer - EORTC: lead

Study Sites (46)

Innsbruck Universitaetsklinik

Innsbruck, A-6020, Austria

Location

St. Johanns-Spital

Salzburg, A-5020, Austria

Location

Institut Jules Bordet

Brussels, 1000, Belgium

Location

U.Z. Gasthuisberg

Leuven, B-3000, Belgium

Location

H. Hartziekenhuis - Roeselaere.

Roeselare, 8800, Belgium

Location

Centre Hospitalier Peltzer-La Tourelle

Verviers, B-4800, Belgium

Location

University Hospital Rebro

Zagreb, 41000, Croatia

Location

First Medical Clinic of Charles University Hospital

Prague, 128 08, Czechia

Location

Institute of Hematology and Blood Transfusion

Prague, 128 20, Czechia

Location

Charite University Hospital - Campus Virchow Klinikum

Berlin, D-13353, Germany

Location

Staedtisches Klinikum Braunschweig

Braunschweig, G-38114, Germany

Location

DIAKO Ev. Diakonie Krankenhaus gGmbH

Bremen, 28239, Germany

Location

Universitatsklinikum Carl Gustav Carus

Dresden, D-01307, Germany

Location

St. Johannes Hospital - Medical Klinik II

Duisburg, D-47166, Germany

Location

St. Antonius Hospital

Eschweiler, DOH-52249, Germany

Location

Klinikum der J.W. Goethe Universitaet

Frankfurt, D-60590, Germany

Location

Universitaetsklinikum Freiburg

Freiburg im Breisgau, D-79106, Germany

Location

Klinikum der Albert - Ludwigs - Universitaet Freiburg

Freiburg im Breisgau, DOH-79104, Germany

Location

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

Greifswald, D-17487, Germany

Location

Medizinische Hochschule Hannover

Hanover, D-30625, Germany

Location

Ruprecht - Karls - Universitaet Heidelberg

Heidelberg, D-69117, Germany

Location

Universitaetsklinikum des Saarlandes

Homburg, D-66421, Germany

Location

Westpfalz-Klinikum GmbH

Kaiserslautern, D-67653, Germany

Location

Onkologische Schwerpunktpraxis - Leer

Leer, D-26789, Germany

Location

Sana Kliniken Luebeck

Lübeck, 23560, Germany

Location

Kreiskrankenhaus Luedenscheid

Lüdenscheid, 58515, Germany

Location

Klinikum der Universitaet Muenchen - Grosshadern Campus

Munich, D-81377, Germany

Location

Staedtisches Krankenhaus Muenchen - Harlaching

Munich, D-81545, Germany

Location

Klinikum Rechts Der Isar - Technische Universitaet Muenchen

Munich, D-81675, Germany

Location

Robert-Bosch-Krankenhaus

Stuttgart, D-70376, Germany

Location

Southwest German Cancer Center at Eberhard-Karls-University

Tübingen, D-72076, Germany

Location

Klinikum Der Stadt Villingen - Schwenningen

Villingen-Schwenningen, D-78054, Germany

Location

Medizinische Poliklinik, Universitaet Wuerzburg

Würzburg, D-97070, Germany

Location

Universita Degli Studi di Florence - Policlinico di Careggi

Florence, 50134, Italy

Location

Azienda Ospedaliera Vito Fazzi

Lecce, 73100, Italy

Location

Azienda Ospedale - d S. Salvatore

Pesaro, I-61100, Italy

Location

Istituto Regina Elena

Rome, 00161, Italy

Location

Policlinico A. Gemelli - Universita Cattolica del Sacro Cuore

Rome, 00168, Italy

Location

Onze Lieve Vrouwe Gasthuis

Amsterdam, 1091 HA, Netherlands

Location

Leiden University Medical Center

Leiden, 2300 CA, Netherlands

Location

Academisch Ziekenhuis Maastricht

Maastricht, 6202 AZ, Netherlands

Location

Universitair Medisch Centrum St. Radboud - Nijmegen

Nijmegen, NL-6500 HB, Netherlands

Location

HagaZiekenhuis - Locatie Leyenburg

The Hague, 2545 CH, Netherlands

Location

Kantonsspital - Abteilung Onkologie

Basel, 4031, Switzerland

Location

Ibn-i Sina Hospital

Ankara, 06100, Turkey (Türkiye)

Location

Royal South Hants Hospital

Southampton, England, SO14 0YG, United Kingdom

Location

Related Publications (1)

• 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.

  RESULT

MeSH Terms

Conditions

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

Interventions

Decitabine

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Bone Marrow Diseases; Leukemia, Myeloid; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Anemia

Intervention Hierarchy (Ancestors)

Azacitidine; Aza Compounds; Organic Chemicals; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Study Officials

• Pierre W. Wijermans, MD, PhD

  HagaZiekenhuis - Locatie Leyenburg

• Michael Luebbert, MD

  University Hospital Freiburg

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: NETWORK

Study Record Dates

• First Submitted: August 5, 2002
• First Posted: January 27, 2003
• Study Start: May 1, 2002
• Primary Completion: May 1, 2008
• Last Updated: April 13, 2010

Record last verified: 2008-04

Locations

DE (24); CR (1); CZ (2); CH (1); IT (5); TU (1); AU (2); GB (1); BE (4); NL (5)