Leukemia Clinical Trial
— AML-17Official title:
Gemtuzumab Ozogamicin (GO) Combined With Standard Intensive Chemotherapy Versus Standard Intensive Chemotherapy Alone For Induction/Consolidation In Patients 61-75 Years Old With Previously Untreated AML: A Randomized Phase III Trial (AML-17) Of The EORTC-LG and the GIMEMA-ALWP
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.
Status | Completed |
Enrollment | 472 |
Est. completion date | February 2012 |
Est. primary completion date | January 2008 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 61 Years to 75 Years |
Eligibility |
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 |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Austria | A. oe. Krankenhaus der Barmherzigen Schwestern Kinderabteilung | Linz | |
Austria | Allgemeines Krankenhaus - Universitatskliniken | Vienna | |
Belgium | AZ Sint-Jan | Brugge | |
Belgium | Centre Hospitalier Universitaire Brugmann | Brussels | |
Belgium | Hopital Universitaire Erasme | Brussels | |
Belgium | Institut Jules Bordet | Brussels | |
Belgium | Universitair Ziekenhuis Antwerpen | Edegem | |
Belgium | Hopital de Jolimont | Haine Saint Paul | |
Belgium | CHU Liege - Domaine Universitaire du Sart Tilman | Liege | |
Belgium | Centre Hospitalier Peltzer-La Tourelle | Verviers | |
France | Hopital Edouard Herriot | Lyon | |
France | Centre Antoine Lacassagne | Nice | |
France | Hotel Dieu de Paris | Paris | |
Germany | Klinikum der Albert - Ludwigs - Universitaet Freiburg | Freiburg | |
Germany | Ruprecht - Karls - Universitaet Heidelberg | Heidelberg | |
Germany | Southwest German Cancer Center at Eberhard-Karls-University | Tuebingen | |
Italy | Universita Degli Studi di Bari | Bari | |
Italy | Azienda Ospedaliera Di Bologna Policlinico S. Orsola - Malpighi | Bologna | |
Italy | Azienda Sanitaria di Bolzano | Bolzano | |
Italy | Ospedale Binaghi | Cagliari | |
Italy | Ospedale Oncologico A. Businco | Cagliari | |
Italy | Ospedale Ferrarotto | Catania | |
Italy | Ospedale Regionale A. Pugliese | Catanzaro | |
Italy | Azienda Istituti Ospitalieri | Cremona | |
Italy | Universita di Ferrara | Ferrara | |
Italy | Ospedale S. Antonio Abate | Gallarate Varese | |
Italy | Ospedale San Martino | Genoa | |
Italy | Azienda Ospedaliera Papardo | Messina | |
Italy | Universita degli Studi di Messina | Messina | |
Italy | Ospedale Civile Umberto I | Mestre | |
Italy | Azienda Ospedaliera - Universitaria di Modena | Modena | |
Italy | Azienda Ospedaliera "A. Cardarelli" | Naples | |
Italy | Federico II University Medical School | Naples | |
Italy | Azienda Ospedaliera Maggiore Della Carita | Novara | |
Italy | Azienda Ospedale S. Luigi at University of Torino | Orbassano | |
Italy | Azienda Ospedaliera Policlinico Paolo Giaccone | Palermo | |
Italy | Ospedale Cervello | Palermo | |
Italy | Ospedale La Maddalena - Palermo | Palermo | |
Italy | Perugia Regional Cancer Center | Perugia | |
Italy | Azienda Ospedale - d "S. Salvatore" | Pesaro | |
Italy | Ospedale Civile Pescara | Pescara | |
Italy | H. San Giovanni-Addolorata Hospital | Rome | |
Italy | Libero Istituto Universitario Campus Bio-Medico | Rome | |
Italy | Ospedale Sant' Eugenio | Rome | |
Italy | Policlinico A. Gemelli - Universita Cattolica del Sacro Cuore | Rome | |
Italy | Universita Degli Studi "La Sapeinza" | Rome | |
Italy | Istituto di Ematologia Universita - University di Sassari | Sassari | |
Italy | Policlinico G. B. Rossi - Borgo Roma | Verona | |
Italy | Ospedale San Bortolo | Vicenza | |
Netherlands | Jeroen Bosch Ziekenhuis | 's-Hertogenbosch | |
Netherlands | Onze Lieve Vrouwe Gasthuis | Amsterdam | |
Netherlands | Leiden University Medical Center | Leiden | |
Netherlands | Universitair Medisch Centrum St. Radboud - Nijmegen | Nijmegen | |
Netherlands | Maxima Medisch Centrum - Veldhoven | Veldhoven | |
Portugal | Hospital Escolar San Joao | Porto |
Lead Sponsor | Collaborator |
---|---|
European Organisation for Research and Treatment of Cancer - EORTC | Gruppo Italiano Malattie EMatologiche dell'Adulto |
Austria, Belgium, France, Germany, Italy, Netherlands, Portugal,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Overall survival | No | ||
Secondary | Response (complete remission [CR] or complete remission with incomplete recovery of platelet count [CRp]) rate after induction | No | ||
Secondary | Disease-free survival after CR/CRp | No | ||
Secondary | Incidence of relapse after CR/CRp | No | ||
Secondary | Incidence of death without relapse after CR/CRp | No | ||
Secondary | Event-free survival | No | ||
Secondary | Toxicity (highest grade) assessed by International Working Group CTC v2.0 | Yes |
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