Combination Chemotherapy Followed by Bone Marrow or Peripheral Stem Cell Transplantation in Treating Patients With Acute Myelogenous Leukemia

NCT00002549 | Unknown Phase 3

• 2 other identifiers: CDR0000063311EORTC-06931
• Study Type: interventional
• Target: 1,520
• Locations: 11 countries
• Sites: 75

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 or bone marrow 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 combination chemotherapy followed by bone marrow or peripheral stem cell transplantation in treating patients with acute myelogenous leukemia.

Conditions

Leukemia

Keywords

untreated adult acute myeloid leukemia; adult acute erythroid leukemia (M6); adult acute myeloblastic leukemia without maturation (M1); adult acute myeloblastic leukemia with maturation (M2); adult acute myelomonocytic leukemia (M4); adult acute monoblastic leukemia (M5a); adult acute megakaryoblastic leukemia (M7); secondary acute myeloid leukemia; adult acute monocytic leukemia (M5b)

Interventions

filgrastim BIOLOGICAL

busulfan DRUG

cyclophosphamide DRUG

cytarabine DRUG

daunorubicin hydrochloride DRUG

etoposide DRUG

idarubicin DRUG

mesna DRUG

mitoxantrone hydrochloride DRUG

allogeneic bone marrow transplantation PROCEDURE

autologous bone marrow transplantation PROCEDURE

peripheral blood stem cell transplantation PROCEDURE

radiation therapy RADIATION

Eligibility Criteria

• Age: 15 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

DISEASE CHARACTERISTICS: Newly diagnosed acute myeloid leukemia (AML) of any FAB histology (M1-M7) except M3 At least 30% blast cells in bone marrow smears Secondary leukemias eligible, as follows: Following cured malignancies, including Hodgkin's disease Following exposure to alkylating agents or radiotherapy for other reasons The following leukemias are excluded: Blast crisis of chronic myeloid leukemia Leukemia secondary to other myeloproliferative disease Leukemia secondary to myelodysplastic syndrome of more than 6 months' duration No other progressive malignant disease PATIENT CHARACTERISTICS: Age: 15 to 60 Performance status: Not specified Hematopoietic: Not applicable Hepatic: Bilirubin no greater than 1.5 x ULN Renal: Creatinine no greater than 1.5 x ULN Cardiovascular: No severe heart failure requiring diuretics or with an LVEF less than 50% Other: No severe concomitant neurologic disease No severe concomitant psychologic disease PRIOR CONCURRENT THERAPY: No prior therapy for AML (chemotherapy, radiotherapy, or more than 7 days of corticosteroids)

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 (75)

Universitaetsklinik

Innsbruck, A-6020, Austria

Location

Algemeen Ziekenhuis Middelheim

Antwerp, 2020, Belgium

Location

A.Z. St. Jan

Bruges, 8000, Belgium

Location

Hopital Universitaire Erasme

Brussels, 1070, Belgium

Location

Institut Jules Bordet

Brussels (Bruxelles), 1000, Belgium

Location

Universitair Ziekenhuis Antwerpen

Edegem, B-2650, Belgium

Location

CHU Sart-Tilman

Liège, B-4000, Belgium

Location

University Hospital Rebro

Zagreb, 41000, Croatia

Location

Medical School/University of Zagreb

Zagreb (Agram), 41000, Croatia

Location

University Hospital - Olomouc

Olomouc, 775 20, Czechia

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 Cochin

Paris, 75674, France

Location

Hopital Necker

Paris, 75743, France

Location

Centre Medico-Chirurgical Foch

Suresnes, 92151, France

Location

Institut Gustave Roussy

Villejuif, F-94805, France

Location

Staedtische Kliniken Duisburg

Duisburg, D-47055, Germany

Location

Klinikum Grosshadern

Munich (Muenchen), D-81377, Germany

Location

County Hospital

Kecskemét, H-6000, Hungary

Location

Ospedale Civile Alessandria

Alessandria, I-15100, Italy

Location

Ospedale Torrette University Ancona

Ancona, 60020, Italy

Location

Ospedale Civile Avellino

Avellino, Italy

Location

Universita Degli Studi di Bari Policlinico

Bari, 70124, Italy

Location

Ospedale Regionale A. Di Summa

Brindisi, I-72100, Italy

Location

Ospedale Oncologico A. Businco

Cagliari, 09124, Italy

Location

Ospedale Ferrarotto

Catania, 95124, Italy

Location

Ospedale Regionale A. Pugliese

Catanzaro, 88100, Italy

Location

Centro Trapianti di Midollo Osseo

Cremona, 26100, Italy

Location

Ospedale Santa Croce

Cuneo, 12100, Italy

Location

Universita Degli Studi di Firenze - Policlin. di Careggi

Firenze (Florence), 1 (50-134), Italy

Location

Ospedali Riuniti Foggia

Foggia, 71100, Italy

Location

Ospedale S. Antonio Abate

Gallarate Varese, 21013, Italy

Location

Ospedale San Martino/Cliniche Universitarie Convenzionale

Genoa (Genova), 16132, Italy

Location

Ospedale Gen. Provinciale Santa Maria Goretti

Latina, 04100, Italy

Location

Ospedale Maggiore Lodi

Lodi, I-20075, Italy

Location

Instituto Scientifico H.S. Raffaele

Milano (Milan), 20132, Italy

Location

Ospedale Maggiore Ca Granda

Milano (Milan), 20162, Italy

Location

Universita di Modena

Modena, 41100, Italy

Location

Azienda Ospedaliera "A. Cardarelli"

Naples (Napoli), 80127, Italy

Location

Federico II University Medical School

Naples (Napoli), 80131, Italy

Location

Ospedale S. Gennora USL 42

Naples (Napoli), 80136, Italy

Location

Ospedale Nuovo Pellegrini

Naples (Napoli), 80144, Italy

Location

Ospedale Maggiore

Novara, 28100, Italy

Location

Ospedale San Francesco

Nuoro, 08100, Italy

Location

Azienda Ospedale S. Luigi - Universita Di Torino

Orbassano, (Torino), 10043, Italy

Location

Policlinico - Cattedra di Ematologia

Palermo, 90100, Italy

Location

Policlinico P. Giaccone - Universita Di Palermo

Palermo, 90127, Italy

Location

Ospedale Cervello

Palermo, 90146, Italy

Location

Azienda Ospedaliera Di Parma

Parma, 43100, Italy

Location

University and I.R.C.C.S. Policlinico San Matteo

Pavia, 27100, Italy

Location

Policlinico Monteluce

Perugia, 06122, Italy

Location

Ospedale San Salvatore

Pesaro, I-61100, Italy

Location

Ospedale Civile Pescara

Pescara, 65100, Italy

Location

Ospedale San Carlo

Potenza, 85100, Italy

Location

Ospedali Riuniti

Reggio Calabria, 89100, Italy

Location

Arcispedale S. Maria Nuova

Reggio Emilia, 42100, Italy

Location

Ospedale San Eugenio

Rome, 00144, Italy

Location

Azienda Policlinico Umberto Primo

Rome, 00161, Italy

Location

Policlinico A. Gemelli - Universita Cattolica del Sacro Cuore

Rome, 00168, Italy

Location

Ospedale Casa Sollievo della Sofferenza

San Giovanni Rotondo, 71013, Italy

Location

Istituto di Ematologia Universita - University di Sassari

Sassari, 07100, Italy

Location

Azienda Ospedaliera Ospedale E. Mortelli

Sondalo (so), 23037, Italy

Location

Ospedal SS Annunziata

Taranto, 74100, Italy

Location

Ospedale Molinette

Turin (Torino), 10126, Italy

Location

Groot Ziekengasthuis 's-Hertogenbosch

's-Hertogenbosch, 5211 NL, Netherlands

Location

Onze Lieve Vrouwe Gasthuis

Amsterdam, 1091 HA, Netherlands

Location

Medisch Spectrum Twente

Enschede, 7500 KA, Netherlands

Location

Leiden University Medical Center

Leiden, 2300 ZA, Netherlands

Location

University Medical Center Nijmegen

Nijmegen, NL-6252 HB, Netherlands

Location

Sint Joseph Ziekenhuis

Veldhoven, 5500 MB DB, Netherlands

Location

Hospitais da Universidade de Coimbra (HUC)

Coimbra, 3049, Portugal

Location

Hospital Escolar San Joao

Porto, 4200, Portugal

Location

Ibn-i Sina Hospital, Ankara Univeristy

Ankara, 06100, Turkey (Türkiye)

Location

Related Publications (5)

• Maurillo L, Buccisano F, Spagnoli A, et al.: In acute myeloid leukemia, the use in induction of standard dose arac is associated with a better quality of response as compared to an induction regimen containing high dose arac. [Abstract] Blood 114 (22): A-1584, 2009.

  BACKGROUND

• Oosterveld, M, Suciu S, Muus P, et al.: A new prognostic disease specific model to predict survival after intensive antileukemic treatment for young patients with poor-risk MDS and AML: results of the CRIANT and AML-10 studies conducted by the EORTC/GIMEMA/SAKK/HOVON/EBMT groups. [Abstract] Blood 104 (11): A-2020, 2004.

  BACKGROUND

• Mandelli F, Vignetti M, Suciu S, Stasi R, Petti MC, Meloni G, Muus P, Marmont F, Marie JP, Labar B, Thomas X, Di Raimondo F, Willemze R, Liso V, Ferrara F, Baila L, Fazi P, Zittoun R, Amadori S, de Witte T. Daunorubicin versus mitoxantrone versus idarubicin as induction and consolidation chemotherapy for adults with acute myeloid leukemia: the EORTC and GIMEMA Groups Study AML-10. J Clin Oncol. 2009 Nov 10;27(32):5397-403. doi: 10.1200/JCO.2008.20.6490. Epub 2009 Oct 13.

  PMID: 19826132 RESULT

• Baron F, Stevens-Kroef M, Kicinski M, Meloni G, Muus P, Marie JP, Halkes CJM, Thomas X, Vrhovac R, Albano F, Lefrere F Sr, Sica S, Mancini M, Venditti A, Hagemeijer A, Jansen JH, Amadori S, de Witte T, Willemze R, Suciu S. Impact of induction regimen and allogeneic hematopoietic cell transplantation on outcome in younger adults with acute myeloid leukemia with a monosomal karyotype. Haematologica. 2019 Jun;104(6):1168-1175. doi: 10.3324/haematol.2018.204826. Epub 2018 Dec 6.

  PMID: 30523055 DERIVED

• Baron F, Stevens-Kroef M, Kicinski M, Meloni G, Muus P, Marie JP, Halkes CJM, Thomas X, Vrhovac R, Specchia G, Lefrere F Sr, Sica S, Mancini M, Venditti A, Hagemeijer A, Becker H, Jansen JH, Amadori S, de Witte T, Willemze R, Suciu S. Cytogenetic clonal heterogeneity is not an independent prognosis factor in 15-60-year-old AML patients: results on 1291 patients included in the EORTC/GIMEMA AML-10 and AML-12 trials. Ann Hematol. 2018 Oct;97(10):1785-1795. doi: 10.1007/s00277-018-3396-4. Epub 2018 Jun 20.

  PMID: 29926156 DERIVED

MeSH Terms

Conditions

Leukemia; Leukemia, Erythroblastic, Acute; Leukemia, Myeloid, Acute; Leukemia, Myelomonocytic, Acute; Leukemia, Monocytic, Acute; Leukemia, Megakaryoblastic, Acute

Interventions

Filgrastim; Busulfan; Cyclophosphamide; Cytarabine; Daunorubicin; Etoposide; Idarubicin; Mesna; Mitoxantrone; Peripheral Blood Stem Cell Transplantation; Radiotherapy

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukemia, Myeloid; Myeloproliferative Disorders; Bone Marrow Diseases

Intervention Hierarchy (Ancestors)

Granulocyte Colony-Stimulating Factor; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Butylene Glycols; Glycols; Alcohols; Organic Chemicals; Mesylates; Alkanesulfonates; Alkanesulfonic Acids; Alkanes; Hydrocarbons, Acyclic; Hydrocarbons; Sulfonic Acids; Sulfur Acids; Sulfur Compounds; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Arabinonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Polycyclic Compounds; Aminoglycosides; Glycosides; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Glucosides; Sulfhydryl Compounds; Anthraquinones; Anthrones; Anthracenes; Quinones; Hematopoietic Stem Cell Transplantation; Stem Cell Transplantation; Cell Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Therapeutics; Transplantation; Surgical Procedures, Operative

Study Officials

• Robert A. Zittoun, MD

  Hotel Dieu de Paris

  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: July 19, 2004
• Study Start: November 1, 1993
• Last Updated: December 23, 2009

Record last verified: 2009-12

Locations

CZ (2); IT (45); BE (6); TU (1); AU (1); NL (6); PT (2); CR (2); HU (1); FR (7); DE (2)