Combination Chemotherapy With or Without Peripheral Stem Cell Transplantation in Treating Patients With Myelodysplastic Syndrome or Acute Myelogenous Leukemia

Phase 3

• Conditions: Leukemia; Myelodysplastic Syndromes

• Registration Number: NCT00002926
• Lead Sponsor: European Organisation for Research and Treatment of Cancer - EORTC

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells.

PURPOSE: Randomized phase III trial to compare the effectiveness of peripheral stem cell transplantation with high-dose cytarabine in treating patients with myelodysplastic syndrome or acute myelogenous leukemia.

Detailed Description

OBJECTIVES:

* Assess the value of autologous peripheral stem cell transplantation versus high dose cytarabine (Ara-C) performed after a common induction and consolidation course in patients with poor prognosis myelodysplastic syndromes (MDS) or acute myelogenous leukemia secondary to MDS.

* Compare the disease free survival and overall survival of patients who reached complete recovery according to the presence of an HLA-identical donor.

* Monitor cytogenetic and clonal remission after intensive antileukemic therapy including stem cell transplantation.

* Monitor residual disease and the hematopoietic clonal status of autologous peripheral blood stem cells mobilized after one consolidation course.

* Assess recovery time of granulocyte and platelet counts following each treatment step.

OUTLINE: Induction treatment with idarubicin on days 1,3,5; Ara-C from days 1 through 10; etoposide on days 1 through 5. On day 28 there will be assessment of responses. If there is at least partial response, the cycle will repeat the induction course for another 28 days. There is peripheral blood stem cell collection and cryopreservation following family HLA-typing. If there is no HLA match, then those who remained in remission after these consolidation courses will be randomized to either peripheral blood stem cell transplantation or HiDAC treatment.

PROJECTED ACCRUAL: 80 patients will be entered per year.

Study Timeline

• Study Start: 1996-12
• Study First Submitted: 1999-11-01
• Status Verified: 2001-05
• Study First Submitted QC: 2003-01-26
• Study First Posted: 2003-01-27
• Last Update Submitted: 2010-05-26
• Last Update Posted: 2010-05-27

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (40)

Hopital Universitaire Erasme; 🇧🇪 Brussels, Belgium

Cliniques Universitaires Saint-Luc; 🇧🇪 Brussels, Belgium

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

Leyenburg Ziekenhuis; 🇳🇱 's-Gravenhage, Netherlands

Academisch Medisch Centrum; 🇳🇱 Amsterdam, Netherlands

Academisch Ziekenhuis Maastricht; 🇳🇱 Maastricht, Netherlands

Hopital Cantonal Universitaire de Geneva; 🇨🇭 Geneva, Switzerland

Clinique Universitaire De Mont-Godinne; 🇧🇪 Mont-Godinne Yvoir, Belgium

Ospedale San Giovanni; 🇨🇭 Bellinzona, Switzerland

Algemeen Ziekenhuis Middelheim; 🇧🇪 Antwerp, Belgium

A.Z. St. Jan; 🇧🇪 Brugge, Belgium

Inselspital, Bern; 🇨🇭 Bern, Switzerland

Kantonsspital - St. Gallen; 🇨🇭 St. Gallen, Switzerland

University Hospital Rebro; 🇭🇷 Zagreb, Croatia

Leiden University Medical Center; 🇳🇱 Leiden, Netherlands

Centre Hospitalier Universitaire Vaudois; 🇨🇭 Lausanne, Switzerland

Universitair Ziekenhuis Antwerpen; 🇧🇪 Edegem, Belgium

Onze Lieve Vrouwe Gasthuis; 🇳🇱 Amsterdam, Netherlands

University Medical Center Nijmegen; 🇳🇱 Nijmegen, Netherlands

Erasmus Medical Center; 🇳🇱 Rotterdam, Netherlands

Institut Jules Bordet; 🇧🇪 Brussels, Belgium

Eberhard Karls Universitaet; 🇩🇪 Tuebingen, Germany

University Hospital; 🇨🇭 Basel, Switzerland

Huddinge University Hospital; 🇸🇪 Stockholm, Sweden

U.Z. Gasthuisberg; 🇧🇪 Leuven, Belgium

Universitaetsklinik Duesseldorf; 🇩🇪 Duesseldorf, Germany

Hopital Edouard Herriot; 🇫🇷 Lyon, France

Hopital Necker; 🇫🇷 Paris, France

Centre Antoine Lacassagne; 🇫🇷 Nice, France

Hotel Dieu de Paris; 🇫🇷 Paris, France

Universitaetsklinik und Strahlenklinik - Essen; 🇩🇪 Essen, Germany

Medizinische Klinik und Poliklinik; 🇩🇪 Heidelberg, Germany

Klinikum Grosshadern; 🇩🇪 Munich (Muenchen), Germany

Ospedale San Eugenio; 🇮🇹 Rome, Italy

Vrije Universiteit Medisch Centrum; 🇳🇱 Amsterdam, Netherlands

University Hospital - Rotterdam Dijkzigt; 🇳🇱 Rotterdam, Netherlands

University Hospital of Linkoping; 🇸🇪 Linkoping, Sweden

Sophia Ziekehuis; 🇳🇱 Zwolle, Netherlands

Sahlgrenska University Hospital; 🇸🇪 Gothenburg (Goteborg), Sweden

Orebro University Hospital; 🇸🇪 Orebro, Sweden