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

NCT00002926 | Unknown Phase 3

• 2 other identifiers: CDR0000065336EORTC-06961
• Study Type: interventional
• Target: 80
• Locations: 9 countries
• Sites: 40

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.

Conditions

Leukemia; Myelodysplastic Syndromes

Keywords

secondary acute myeloid leukemia; refractory anemia; refractory anemia with ringed sideroblasts; refractory anemia with excess blasts; refractory anemia with excess blasts in transformation; chronic myelomonocytic leukemia; de novo myelodysplastic syndromes; previously treated myelodysplastic syndromes; secondary myelodysplastic syndromes; refractory cytopenia with multilineage dysplasia; childhood myelodysplastic syndromes

Interventions

cytarabine DRUG

etoposide DRUG

idarubicin DRUG

allogeneic bone marrow transplantation PROCEDURE

peripheral blood stem cell transplantation PROCEDURE

Eligibility Criteria

• Age: 16 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

DISEASE CHARACTERISTICS: * Pathological confirmation of one of the following: * Untreated refractory anemia with excess blasts (RAEB) in transformation * RAEB with greater than 10% blasts cells in the bone marrow * Other myelodysplastic syndromes * Profound cytopenias * Acute myelogenous leukemia (AML) supervening after overt myelodysplastic syndromes (MDS) of more than 6 months duration * No blast crisis of chronic myeloid leukemia * No leukemias supervening after other myeloproliferative disease * No leukemias supervening after overt MDS of less than 6 months duration * The following are allowed: * Secondary acute leukemias following Hodgkin's disease or other malignancies * Secondary leukemias following exposure to alkylating agents or radiation PATIENT CHARACTERISTICS: Age: * 16-60 Performance status: * WHO 0-2 Hematopoietic: * If RAEB, blasts cells of greater than 10% in bone marrow * Neutrophil count less than 5,000 or Platelet count less than 200,000 * Chronic myelomonocytic leukemia (CMML) with greater than 5% blasts cells in bone marrow, or CMML with neutrophil count greater than 160,000 or monocyte count greater than 2,600 Hepatic: * Bilirubin no greater than 1.5 times normal Renal: * Creatinine no greater than 1.5 times normal Cardiovascular: * No patients with severe heart failure requiring diuretics or an ejection fraction of less than 50% Neurological: * No severe concomitant neurological disease PRIOR CONCURRENT THERAPY: Biologic therapy: * No treatments within the past 4 weeks of: * Biological response modifiers AND/OR * Low dose Ara-C Chemotherapy: * No prior intensive treatment for MDS or AML Endocrine therapy: * Not specified Radiotherapy: * No prior treatment for MDS or AML Surgery: * Not specified

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 (40)

Algemeen Ziekenhuis Middelheim

Antwerp, 2020, Belgium

Location

A.Z. St. Jan

Bruges, 8000, Belgium

Location

Institut Jules Bordet

Brussels, 1000, Belgium

Location

Hopital Universitaire Erasme

Brussels, 1070, Belgium

Location

Cliniques Universitaires Saint-Luc

Brussels, 1200, Belgium

Location

Universitair Ziekenhuis Antwerpen

Edegem, B-2650, Belgium

Location

U.Z. Gasthuisberg

Leuven, B-3000, Belgium

Location

Clinique Universitaire De Mont-Godinne

Mont-Godinne Yvoir, 5530, Belgium

Location

University Hospital Rebro

Zagreb, 10000, Croatia

Location

Institute of Hematology and Blood Transfusion

Prague, 128 20, Czechia

Location

Hopital Edouard Herriot

Lyon, 69437, France

Location

Centre Antoine Lacassagne

Nice, 06189, France

Location

Hotel Dieu de Paris

Paris, 75181, France

Location

Hopital Necker

Paris, 75743, France

Location

Universitaetsklinik Duesseldorf

Düsseldorf, D-40225, Germany

Location

Universitaetsklinik und Strahlenklinik - Essen

Essen, D-45122, Germany

Location

Medizinische Klinik und Poliklinik

Heidelberg, 92093-0671, Germany

Location

Klinikum Grosshadern

Munich (Muenchen), D-81377, Germany

Location

Eberhard Karls Universitaet

Tübingen, D-72076, Germany

Location

Ospedale San Eugenio

Rome, 00144, Italy

Location

Vrije Universiteit Medisch Centrum

Amsterdam, 1001HV, Netherlands

Location

Onze Lieve Vrouwe Gasthuis

Amsterdam, 1091 HA, Netherlands

Location

Academisch Medisch Centrum

Amsterdam, 1105 AZ, Netherlands

Location

Leiden University Medical Center

Leiden, 2300 CA, Netherlands

Location

Academisch Ziekenhuis Maastricht

Maastricht, 6202 AZ, Netherlands

Location

University Medical Center Nijmegen

Nijmegen, NL-6500 HB, Netherlands

Location

University Hospital - Rotterdam Dijkzigt

Rotterdam, 3000 CA, Netherlands

Location

Erasmus Medical Center

Rotterdam, 3075 EA, Netherlands

Location

Leyenburg Ziekenhuis

The Hague, 2545 CH, Netherlands

Location

Sophia Ziekehuis

Zwolle, 8000 GK, Netherlands

Location

Sahlgrenska University Hospital

Gothenburg (Goteborg), S-413 45, Sweden

Location

University Hospital of Linkoping

Linköping, S-581 85, Sweden

Location

Orebro University Hospital

Örebro, 70185, Sweden

Location

Huddinge University Hospital

Stockholm, SE-141 86, Sweden

Location

University Hospital

Basel, CH-4031, Switzerland

Location

Ospedale San Giovanni

Bellinzona, CH-6500, Switzerland

Location

Inselspital, Bern

Bern, CH-3010, Switzerland

Location

Hopital Cantonal Universitaire de Geneva

Geneva, CH-1211, Switzerland

Location

Centre Hospitalier Universitaire Vaudois

Lausanne, CH-1011, Switzerland

Location

Kantonsspital - St. Gallen

Sankt Gallen, CH-9007, Switzerland

Location

Related Publications (1)

• de Witte T, Hagemeijer A, Suciu S, Belhabri A, Delforge M, Kobbe G, Selleslag D, Schouten HC, Ferrant A, Biersack H, Amadori S, Muus P, Jansen JH, Hellstrom-Lindberg E, Kovacsovics T, Wijermans P, Ossenkoppele G, Gratwohl A, Marie JP, Willemze R. Value of allogeneic versus autologous stem cell transplantation and chemotherapy in patients with myelodysplastic syndromes and secondary acute myeloid leukemia. Final results of a prospective randomized European Intergroup Trial. Haematologica. 2010 Oct;95(10):1754-61. doi: 10.3324/haematol.2009.019182. Epub 2010 May 21.

  PMID: 20494931 RESULT

MeSH Terms

Conditions

Leukemia; Myelodysplastic Syndromes; Anemia, Refractory; Anemia, Refractory, with Excess of Blasts; Leukemia, Myelomonocytic, Chronic

Interventions

Cytarabine; Etoposide; Idarubicin; Peripheral Blood Stem Cell Transplantation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Arabinonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Glucosides; Glycosides; Carbohydrates; Daunorubicin; Anthracyclines; Naphthacenes; Aminoglycosides; Hematopoietic Stem Cell Transplantation; Stem Cell Transplantation; Cell Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Therapeutics; Transplantation; Surgical Procedures, Operative

Study Officials

• Theo De Witte, MD, PhD

  Universitair Medisch Centrum St. Radboud - Nijmegen

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: NETWORK

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: January 27, 2003
• Study Start: December 1, 1996
• Last Updated: May 27, 2010

Record last verified: 2001-05

Locations

BE (8); NL (10); SE (4); FR (4); CZ (1); CH (6); CR (1); DE (5); IT (1)