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

Phase 3

• Conditions: Leukemia; Myelodysplastic Syndromes; Myelodysplastic/Myeloproliferative Neoplasms

• Registration Number: NCT00043134
• Lead Sponsor: European Organisation for Research and Treatment of Cancer - EORTC

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.

Study Timeline

• Study Start: 2002-05
• Study First Submitted: 2002-08-05
• Study First Submitted QC: 2003-01-26
• Study First Posted: 2003-01-27
• Status Verified: 2008-04
• Primary Completion: 2008-05
• Last Update Submitted: 2010-04-10
• Last Update Posted: 2010-04-13

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 220

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Duration of overall survival

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (46)

Royal South Hants Hospital; 🇬🇧 Southampton, England, United Kingdom

Policlinico A. Gemelli - Universita Cattolica del Sacro Cuore; 🇮🇹 Rome, Italy

Klinikum der Universitaet Muenchen - Grosshadern Campus; 🇩🇪 Munich, Germany

Sana Kliniken Luebeck; 🇩🇪 Luebeck, Germany

Staedtisches Krankenhaus Muenchen - Harlaching; 🇩🇪 Munich, Germany

Klinikum Rechts Der Isar - Technische Universitaet Muenchen; 🇩🇪 Munich, Germany

Onkologische Schwerpunktpraxis - Leer; 🇩🇪 Leer, Germany

Kreiskrankenhaus Luedenscheid; 🇩🇪 Luedenscheid, Germany

U.Z. Gasthuisberg; 🇧🇪 Leuven, Belgium

Innsbruck Universitaetsklinik; 🇦🇹 Innsbruck, Austria

Institut Jules Bordet; 🇧🇪 Brussels, Belgium

Southwest German Cancer Center at Eberhard-Karls-University; 🇩🇪 Tuebingen, Germany

Robert-Bosch-Krankenhaus; 🇩🇪 Stuttgart, Germany

Onze Lieve Vrouwe Gasthuis; 🇳🇱 Amsterdam, Netherlands

Leiden University Medical Center; 🇳🇱 Leiden, Netherlands

Ibn-i Sina Hospital; 🇹🇷 Ankara, Turkey

HagaZiekenhuis - Locatie Leyenburg; 🇳🇱 's-Gravenhage, Netherlands

Academisch Ziekenhuis Maastricht; 🇳🇱 Maastricht, Netherlands

Universitair Medisch Centrum St. Radboud - Nijmegen; 🇳🇱 Nijmegen, Netherlands

Azienda Ospedaliera Vito Fazzi; 🇮🇹 Lecce, Italy

Azienda Ospedale - d S. Salvatore; 🇮🇹 Pesaro, Italy

Istituto Regina Elena; 🇮🇹 Rome, Italy

Medizinische Poliklinik, Universitaet Wuerzburg; 🇩🇪 Wuerzburg, Germany

St. Johanns-Spital; 🇦🇹 Salzburg, Austria

University Hospital Rebro; 🇭🇷 Zagreb, Croatia

H. Hartziekenhuis - Roeselaere.; 🇧🇪 Roeselare, Belgium

Centre Hospitalier Peltzer-La Tourelle; 🇧🇪 Verviers, Belgium

First Medical Clinic of Charles University Hospital; 🇨🇿 Prague, Czech Republic

Charite University Hospital - Campus Virchow Klinikum; 🇩🇪 Berlin, Germany

Universitatsklinikum Carl Gustav Carus; 🇩🇪 Dresden, Germany

St. Johannes Hospital - Medical Klinik II; 🇩🇪 Duisburg, Germany

Staedtisches Klinikum Braunschweig; 🇩🇪 Braunschweig, Germany

Institute of Hematology and Blood Transfusion; 🇨🇿 Prague, Czech Republic

Klinikum der J.W. Goethe Universitaet; 🇩🇪 Frankfurt, Germany

DIAKO Ev. Diakonie Krankenhaus gGmbH; 🇩🇪 Bremen, Germany

St. Antonius Hospital; 🇩🇪 Eschweiler, Germany

Universitaetsklinikum Freiburg; 🇩🇪 Freiburg, Germany

Klinikum der Albert - Ludwigs - Universitaet Freiburg; 🇩🇪 Freiburg, Germany

Medizinische Hochschule Hannover; 🇩🇪 Hannover, Germany

Klinik Fuer Innere Medizin, Hematology/Oncology, Ernst Moritz Armdt Universitaet; 🇩🇪 Greifswald, Germany

Westpfalz-Klinikum GmbH; 🇩🇪 Kaiserslautern, Germany

Klinikum Der Stadt Villingen - Schwenningen; 🇩🇪 Villingen-Schwenningen, Germany

Ruprecht - Karls - Universitaet Heidelberg; 🇩🇪 Heidelberg, Germany

Universitaetsklinikum des Saarlandes; 🇩🇪 Homburg, Germany

Universita Degli Studi di Florence - Policlinico di Careggi; 🇮🇹 Florence, Italy

Kantonsspital - Abteilung Onkologie; 🇨🇭 Basel, Switzerland