Combination Chemotherapy in Treating Children With Newly Diagnosed Acute Myeloid Leukemia or Myelodysplastic Syndrome

NCT00002517 | Completed Phase 3

• 2 other identifiers: CDR0000078212EORTC-58921
• Study Type: interventional
• Target: N/A
• Locations: 3 countries
• Sites: 23

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. It is not yet known which regimen of combination chemotherapy is more effective for acute myeloid leukemia or myelodysplastic syndrome. PURPOSE: Randomized phase III trial to compare the effectiveness of different combination chemotherapy regimens in treating children who have newly diagnosed acute myeloid leukemia or myelodysplastic syndrome.

Conditions

Leukemia; Myelodysplastic Syndromes

Keywords

childhood myelodysplastic syndromes; untreated childhood acute myeloid leukemia and other myeloid malignancies; childhood acute myeloblastic leukemia without maturation (M1); childhood acute myeloblastic leukemia with maturation (M2); childhood acute myelomonocytic leukemia (M4); childhood acute monoblastic leukemia (M5a); childhood acute monocytic leukemia (M5b); childhood acute erythroleukemia (M6); childhood acute megakaryocytic leukemia (M7); refractory anemia with excess blasts; refractory anemia with excess blasts in transformation; chronic myelomonocytic leukemia; de novo myelodysplastic syndromes; childhood acute minimally differentiated myeloid leukemia (M0)

Interventions

cytarabine DRUG

daunorubicin hydrochloride DRUG

dexamethasone DRUG

etoposide DRUG

idarubicin DRUG

mitoxantrone hydrochloride DRUG

thioguanine DRUG

allogeneic bone marrow transplantation PROCEDURE

radiation therapy RADIATION

Eligibility Criteria

• Age: Up to 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

DISEASE CHARACTERISTICS: * Newly diagnosed acute myeloid leukemia (AML) based on the cytological, cytochemical, and immunological criteria of the FAB classification * Must meet 1 of the following criteria: * More than 30% blasts in marrow (calculation based on the total number of nucleated cells except lymphocytes and plasmocytes) * Presence of granulocytic sarcoma (chloroma) * Disease must be associated with at least 1 of the following: * More than 3% myeloperoxidase- or Sudan black-positive blasts * More than 3% platelet peroxidase-positive blasts * More than 20% esterase-positive blasts * Immunological markers compatible with a myeloid differentiation, including 1 of the following criteria: * Blasts positive for myeloid-associated antigen and negative for B- or T-lymphocyte antigens * Blasts positive for at least 2 myeloid antigens (except CD3 and CD8) * A cytogenetic abnormality associated with AML OR * Newly diagnosed myelodysplastic syndrome (MDS) based on the cytological and cytochemical criteria of the FAB classification * Eligible subtypes: * Refractory anemia with excess blasts (RAEB) * RAEB in transformation * Chronic myelomonocytic leukemia * No promyelocytic leukemia (M3 or M3v) treated with tretinoin (protocol EORTC-06915) * No AML secondary to hematologic or malignant disease other than MDS * Registration must occur within 48 hours of diagnosis PATIENT CHARACTERISTICS: Age: * Under 15 Performance status: * Not specified Life expectancy: * Not specified Hematopoietic: * See Disease Characteristics * No uncontrolled bleeding disorder Hepatic: * Not specified Renal: * No renal failure Cardiovascular: * No congenital heart disease Other: * No encephalopathy * No genetic disorders * No uncontrolled infection PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * Not specified Endocrine therapy: * Not specified Radiotherapy: * Not specified Surgery: * Not specified Other: * No prior antileukemic therapy

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 (23)

Algemeen Ziekenhuis Middelheim

Antwerp, 2020, Belgium

Location

Hopital Universitaire Des Enfants Reine Fabiola

Brussels, 1020, Belgium

Location

Academisch Ziekenhuis der Vrije Universiteit Brussel

Brussels, 1090, Belgium

Location

Universitair Ziekenhuis Gent

Ghent, B-9000, Belgium

Location

U.Z. Gasthuisberg

Leuven, B-3000, Belgium

Location

Centre Hospitalier Regional de la Citadelle

Liège, 4000, Belgium

Location

Clinique de l'Esperance

Montegnée, 4420, Belgium

Location

Centre Hospitalier Regional et Universitaire d'Angers

Angers, 49033, France

Location

CHR de Besancon - Hopital Saint-Jacques

Besançon, 25030, France

Location

CHU de Caen

Caen, 14033, France

Location

CHR de Grenoble - La Tronche

Grenoble, 38043, France

Location

Centre Hospitalier Regional de Lille

Lille, 59037, France

Location

Hopital Debrousse

Lyon, 69322, France

Location

Hopital Arnaud de Villeneuve

Montpellier, 34295, France

Location

CHR Hotel Dieu

Nantes, 44093, France

Location

Centre Antoine Lacassagne

Nice, 06189, France

Location

Hopital Robert Debre

Paris, 75019, France

Location

Institut Curie - Section Medicale

Paris, 75248, France

Location

Hopital Jean Bernard

Poitiers, 86021, France

Location

Hopital Americain

Reims, 51092, France

Location

Hopital Universitaire Hautepierre

Strasbourg, 67098, France

Location

Hopital des Enfants (Purpan Enfants)

Toulouse, 31026, France

Location

Hospital Escolar San Joao

Porto, 4200, Portugal

Location

Related Publications (2)

• Brunet AS, Ploton C, Galambrun C, Pondarre C, Pages MP, Bleyzac N, Freydiere AM, Barbe G, Bertrand Y. Low incidence of sepsis due to viridans streptococci in a ten-year retrospective study of pediatric acute myeloid leukemia. Pediatr Blood Cancer. 2006 Nov;47(6):765-72. doi: 10.1002/pbc.20706.

  PMID: 16333838 RESULT

• Entz-Werle N, Suciu S, van der Werff ten Bosch J, Vilmer E, Bertrand Y, Benoit Y, Margueritte G, Plouvier E, Boutard P, Vandecruys E, Ferster A, Lutz P, Uyttebroeck A, Hoyoux C, Thyss A, Rialland X, Norton L, Pages MP, Philippe N, Otten J, Behar C; EORTC Children Leukemia Group. Results of 58872 and 58921 trials in acute myeloblastic leukemia and relative value of chemotherapy vs allogeneic bone marrow transplantation in first complete remission: the EORTC Children Leukemia Group report. Leukemia. 2005 Dec;19(12):2072-81. doi: 10.1038/sj.leu.2403932.

  PMID: 16136166 RESULT

MeSH Terms

Conditions

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

Interventions

Cytarabine; Daunorubicin; Dexamethasone; Etoposide; Idarubicin; Mitoxantrone; Thioguanine; Radiotherapy

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Bone Marrow Diseases; Anemia, Refractory; 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; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Steroids, Fluorinated; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Glucosides; Anthraquinones; Anthrones; Anthracenes; Quinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Therapeutics

Study Officials

• Catherine Behar, MD

  Hopital Americain

  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: March 1, 1993
• Primary Completion: May 1, 2010
• Last Updated: June 22, 2010

Record last verified: 2002-12

Locations

BE (7); FR (15); PT (1)