Chemotherapy With or Without Gemtuzumab Ozogamicin in Treating Older Patients With Acute Myeloid Leukemia

NCT00052299 | Completed Phase 3

• 3 other identifiers: EORTC-06012AML-17GIMEMA-AML-17
• Study Type: interventional
• Target: 472
• Locations: 7 countries
• Sites: 55

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. It is not yet known if combining combination chemotherapy with monoclonal antibody therapy will kill more cancer cells. PURPOSE: Randomized phase III trial to determine the effectiveness of combination chemotherapy with or without gemtuzumab ozogamicin in treating patients who have acute myeloid leukemia.

Conditions

Leukemia

Keywords

adult acute monocytic leukemia (M5b); adult acute erythroid leukemia (M6); adult acute megakaryoblastic leukemia (M7); adult acute minimally differentiated myeloid leukemia (M0); adult acute myeloblastic leukemia with maturation (M2); adult acute myeloblastic leukemia without maturation (M1); adult acute myelomonocytic leukemia (M4); adult acute monoblastic leukemia (M5a); untreated adult acute myeloid leukemia; secondary acute myeloid leukemia; adult acute myeloid leukemia with 11q23 (MLL) abnormalities; adult acute myeloid leukemia with inv(16)(p13;q22); adult acute myeloid leukemia with t(16;16)(p13;q22); adult acute myeloid leukemia with t(8;21)(q22;q22)

Outcome Measures

Primary Outcomes (1)

• Overall survival

Secondary Outcomes (6)

• Response (complete remission [CR] or complete remission with incomplete recovery of platelet count [CRp]) rate after induction

• Disease-free survival after CR/CRp

• Incidence of relapse after CR/CRp

• Incidence of death without relapse after CR/CRp

• Event-free survival

Study Arms (2)

ARM A

EXPERIMENTAL

GO + MICE for remission induction followed by GO + mini-ICE for consolidation

Drug: cytarabine; Drug: etoposide; Drug: gemtuzumab ozogamicin; Drug: idarubicin; Drug: mitoxantrone hydrochloride

ARM B

ACTIVE COMPARATOR

MICE for remission induction followed by mini-ICE for consolidation

Drug: cytarabine; Drug: etoposide; Drug: idarubicin; Drug: mitoxantrone hydrochloride

Interventions

cytarabine DRUG

ARM A; ARM B

etoposide DRUG

ARM A; ARM B

gemtuzumab ozogamicin DRUG

ARM A

idarubicin DRUG

ARM A; ARM B

mitoxantrone hydrochloride DRUG

ARM A; ARM B

Eligibility Criteria

• Age: 61 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Diagnosis of acute myeloid leukemia (AML) * Bone marrow blasts at least 20% by bone marrow aspiration or biopsy * FAB subtypes M0-M2 and M4-M7 * No acute promyelocytic leukemia (FAB subtype M3) * Previously untreated primary or secondary AML, including AML after myelodysplastic syndromes * Hydroxyurea and/or corticosteroid therapy for no more than 14 days allowed * No blast crisis of chronic myelogenous leukemia * No AML supervening after other myeloproliferative diseases * No active CNS leukemia PATIENT CHARACTERISTICS: Age * 61 to 75 Performance status * WHO 0-2 Life expectancy * Not specified Hematopoietic * WBC less than 30,000/mm\^3 (pretreatment with hydroxyurea for no more than 14 days allowed) Hepatic * Bilirubin no greater than 3 times upper limit of normal (ULN) Renal * Creatinine no greater than 3 times ULN Cardiovascular * No concurrent severe cardiovascular disease * No arrhythmias requiring chronic treatment * No congestive heart failure * No symptomatic ischemic heart disease Pulmonary * No severe pulmonary dysfunction (CTC grade 3-4) Other * HIV negative * No other uncontrolled infection * No other concurrent malignant disease * No severe concurrent neurological or psychiatric disease * No prior alcohol abuse * No psychological, familial, sociological, or geographical condition that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy * No concurrent hematopoietic growth factors (filgrastim \[G-CSF\] or sargramostim \[GM-CSF\]) except for life-threatening infection due to neutropenia Chemotherapy * See Disease Characteristics Endocrine therapy * See Disease Characteristics Radiotherapy * Not specified Surgery * Not specified Other * No prior enrollment in this trial

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
• Gruppo Italiano Malattie EMatologiche dell'Adulto: collaborator

Study Sites (55)

A. oe. Krankenhaus der Barmherzigen Schwestern Kinderabteilung

Linz, 4010, Austria

Location

Allgemeines Krankenhaus - Universitatskliniken

Vienna, A-1090, Austria

Location

AZ Sint-Jan

Bruges, 8000, Belgium

Location

Institut Jules Bordet

Brussels, 1000, Belgium

Location

Hopital Universitaire Erasme

Brussels, 1070, Belgium

Location

Centre Hospitalier Universitaire Brugmann

Brussels, B 1020, Belgium

Location

Universitair Ziekenhuis Antwerpen

Edegem, B-2650, Belgium

Location

Hopital de Jolimont

Haine-Saint-Paul, 7100, Belgium

Location

CHU Liege - Domaine Universitaire du Sart Tilman

Liège, B-4000, Belgium

Location

Centre Hospitalier Peltzer-La Tourelle

Verviers, B-4800, Belgium

Location

Hopital Edouard Herriot

Lyon, 69437, France

Location

Centre Antoine Lacassagne

Nice, 06189, France

Location

Hotel Dieu de Paris

Paris, 75181, France

Location

Klinikum der Albert - Ludwigs - Universitaet Freiburg

Freiburg im Breisgau, D-79106, Germany

Location

Ruprecht - Karls - Universitaet Heidelberg

Heidelberg, D-69117, Germany

Location

Southwest German Cancer Center at Eberhard-Karls-University

Tübingen, D-72076, Germany

Location

Universita Degli Studi di Bari

Bari, 70124, Italy

Location

Azienda Ospedaliera Di Bologna Policlinico S. Orsola - Malpighi

Bologna, 40138, Italy

Location

Azienda Sanitaria di Bolzano

Bolzano, 39100, Italy

Location

Ospedale Binaghi

Cagliari, 090100, Italy

Location

Ospedale Oncologico A. Businco

Cagliari, 09121, Italy

Location

Ospedale Ferrarotto

Catania, 95124, Italy

Location

Ospedale Regionale A. Pugliese

Catanzaro, 88100, Italy

Location

Azienda Istituti Ospitalieri

Cremona, 26100, Italy

Location

Universita di Ferrara

Ferrara, 44100, Italy

Location

Ospedale S. Antonio Abate

Gallarate Varese, 21013, Italy

Location

Ospedale San Martino

Genoa, 16132, Italy

Location

Universita degli Studi di Messina

Messina, 98122, Italy

Location

Azienda Ospedaliera Papardo

Messina, Italy

Location

Ospedale Civile Umberto I

Mestre, 30174, Italy

Location

Azienda Ospedaliera - Universitaria di Modena

Modena, 41100, Italy

Location

Azienda Ospedaliera "A. Cardarelli"

Naples, 80127, Italy

Location

Federico II University Medical School

Naples, 80131, Italy

Location

Azienda Ospedaliera Maggiore Della Carita

Novara, 28100, Italy

Location

Azienda Ospedale S. Luigi at University of Torino

Orbassano, 10043, Italy

Location

Azienda Ospedaliera Policlinico Paolo Giaccone

Palermo, 90127, Italy

Location

Ospedale Cervello

Palermo, 90146, Italy

Location

Ospedale La Maddalena - Palermo

Palermo, Italy

Location

Perugia Regional Cancer Center

Perugia, 06122, Italy

Location

Azienda Ospedale - d "S. Salvatore"

Pesaro, I-61100, Italy

Location

Ospedale Civile Pescara

Pescara, 65100, Italy

Location

Ospedale Sant' Eugenio

Rome, 00144, Italy

Location

Libero Istituto Universitario Campus Bio-Medico

Rome, 00155, Italy

Location

Universita Degli Studi "La Sapeinza"

Rome, 00161, Italy

Location

Policlinico A. Gemelli - Universita Cattolica del Sacro Cuore

Rome, 00168, Italy

Location

H. San Giovanni-Addolorata Hospital

Rome, 00184, Italy

Location

Istituto di Ematologia Universita - University di Sassari

Sassari, 07100, Italy

Location

Policlinico G. B. Rossi - Borgo Roma

Verona, 37134, Italy

Location

Ospedale San Bortolo

Vicenza, 36100, Italy

Location

Jeroen Bosch Ziekenhuis

's-Hertogenbosch, 5211 NL, Netherlands

Location

Onze Lieve Vrouwe Gasthuis

Amsterdam, 1091 HA, Netherlands

Location

Leiden University Medical Center

Leiden, 2300 CA, Netherlands

Location

Universitair Medisch Centrum St. Radboud - Nijmegen

Nijmegen, 6500 HB, Netherlands

Location

Maxima Medisch Centrum - Veldhoven

Veldhoven, 5500 MB, Netherlands

Location

Hospital Escolar San Joao

Porto, 4200, Portugal

Location

Related Publications (1)

• Amadori S, Suciu S, Stasi R, Salih HR, Selleslag D, Muus P, De Fabritiis P, Venditti A, Ho AD, Lubbert M, Thomas X, Latagliata R, Halkes CJ, Falzetti F, Magro D, Guimaraes JE, Berneman Z, Specchia G, Karrasch M, Fazi P, Vignetti M, Willemze R, de Witte T, Marie JP. Sequential combination of gemtuzumab ozogamicin and standard chemotherapy in older patients with newly diagnosed acute myeloid leukemia: results of a randomized phase III trial by the EORTC and GIMEMA consortium (AML-17). J Clin Oncol. 2013 Dec 10;31(35):4424-30. doi: 10.1200/JCO.2013.49.0771. Epub 2013 Oct 14.

  PMID: 24127442 DERIVED

MeSH Terms

Conditions

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

Interventions

Cytarabine; Etoposide; Gemtuzumab; Idarubicin; Mitoxantrone

Condition Hierarchy (Ancestors)

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

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; Calicheamicins; Aminoglycosides; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Daunorubicin; Anthracyclines; Naphthacenes; Anthraquinones; Anthrones; Anthracenes; Quinones

Study Officials

• Sergio Amadori, MD

  Azienda Ospedallera Universitaria - Policlinico Tor Vergata, Roma

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2003
• First Posted: January 27, 2003
• Study Start: September 1, 2002
• Primary Completion: January 1, 2008
• Study Completion: February 1, 2012
• Last Updated: August 27, 2012

Record last verified: 2012-08

Locations

IT (33); NL (5); FR (3); AU (2); PT (1); BE (8); DE (3)