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Sponsors and Collaborators: |
European Organization for Research and Treatment of Cancer Gruppo Italiano Malattie EMatologiche dell'Adulto |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00091234 |
RATIONALE: Monoclonal antibodies such as gemtuzumab ozogamicin can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. It is not yet known whether gemtuzumab ozogamicin is more effective than standard supportive care in treating older patients who have acute myeloid leukemia.
PURPOSE: This randomized phase II/III trial is studying two different gemtuzumab ozogamicin regimens to see how well they work compared to standard supportive care in treating older patients with previously untreated acute myeloid leukemia.
Condition | Intervention | Phase |
---|---|---|
Leukemia |
Drug: gemtuzumab ozogamicin |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control |
Official Title: | Gemtuzumab Ozogamicin (GO) Monotherapy Versus Standard Supportive Care for Previously Untreated AML in Elderly Patients Who Are Not Eligible for Intensive Chemotherapy: A Randomized Phase II/III Trial (AML-19) of the EORTC-LG and GIMEMA-ALWP |
Estimated Enrollment: | 259 |
Study Start Date: | June 2004 |
OBJECTIVES:
OUTLINE: This is a randomized, open-label, multicenter phase II study followed by a phase III study. Patients are stratified according to age (61 to 75 vs 76 to 80 vs 81 and over), CD33-positivity of bone marrow blasts (< 20% vs 20-80% vs > 80% vs unknown), initial WBC before hydroxyurea administration (< 30,000/mm^3 vs ≥ 30,000/mm^3), WHO performance status (0-1 vs 2 vs 3-4), and participating center.
Phase II: Patients are randomized to 1 of 3 treatment arms.
Phase III: Patients are randomized to 1 of 2 treatment arms.
PROJECTED ACCRUAL: A total of 259 patients (75 for phase II [25 per treatment arm] and 184 for phase III [92 per treatment arm]) will be accrued for this study within 2.5 years.
Ages Eligible for Study: | 61 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed acute myeloid leukemia (AML)
Ineligible for intensive chemotherapy, as defined by 1 of the following criteria:
WBC < 30,000/mm^3 and meets 1 of the following criteria:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Belgium | |
AZ Sint-Jan | |
Brugge, Belgium, 8000 | |
Centre Hospitalier Peltzer-La Tourelle | |
Verviers, Belgium, B-4800 | |
CHU Liege - Domaine Universitaire du Sart Tilman | |
Liege, Belgium, B-4000 | |
Universitair Ziekenhuis Antwerpen | |
Edegem, Belgium, B-2650 | |
Institut Jules Bordet | |
Brussels, Belgium, 1000 | |
Hopital Universitaire Erasme | |
Brussels, Belgium, 1070 | |
Italy | |
Azienda Ospedaliera "A. Cardarelli" | |
Naples, Italy, 80127 | |
Azienda Ospedaliera Di Bologna Policlinico S. Orsola - Malpighi | |
Bologna, Italy, 40138 | |
Azienda Ospedaliera Di Parma | |
Parma, Italy, 43100 | |
Azienda Ospedaliera Maggiore Della Carita | |
Novara, Italy, 28100 | |
Ospedale Maggiore dell' Universita | |
Trieste, Italy, 34100 | |
Istituto di Ematologia Universita - University di Sassari | |
Sassari, Italy, 07100 | |
Libero Istituto Universitario Campus Bio-Medico | |
Rome, Italy, 00155 | |
Ospedale Binaghi | |
Cagliari, Italy, 090100 | |
Ospedale Civile Pescara | |
Pescara, Italy, 65100 | |
Ospedale Civile Umberto I | |
Mestre, Italy, 30174 | |
Ospedale Di Montefiascone | |
Montefiascone, Italy, I-01027 | |
Ospedale Ferrarotto | |
Catania, Italy, 95124 | |
Ospedale La Maddalena - Palermo | |
Palermo, Italy | |
H. San Giovanni-Addolorata Hospital | |
Rome, Italy, 00184 | |
Ospedale Oncologico A. Businco | |
Cagliari, Italy, 09121 | |
Ospedale Regionale A. Pugliese | |
Catanzaro, Italy, 88100 | |
Ospedale S. Antonio Abate | |
Gallarate Varese, Italy, 21013 | |
Ospedale San Carlo | |
Potenza, Italy, 85100 | |
Ospedale San Salvatore | |
Pesaro, Italy, I-61100 | |
Policlinico Universitario Tor Vergata | |
Rome, Italy, 00133 | |
Ospedale Sta. Maria Delle Croci | |
Ravenna, Italy, 48100 | |
Perugia Regional Cancer Center | |
Perugia, Italy, 06122 | |
Policlinico A. Gemelli - Universita Cattolica del Sacro Cuore | |
Rome, Italy, 00168 | |
Ospedale Sant' Eugenio | |
Rome, Italy, 00144 | |
Universita Degli Studi "La Sapeinza" | |
Rome, Italy | |
Universita Degli Studi di Bari | |
Bari, Italy, 70124 | |
Universita degli Studi di Modena e Reggio Emilia | |
Modena, Italy, 41100 | |
Universita di Ferrara | |
Ferrara, Italy, 44100 | |
Universita Di Palermo | |
Palermo, Italy, 90141 | |
Universita di Siena | |
Siena, Italy, 53100 | |
Netherlands | |
Jeroen Bosch Ziekenhuis | |
's-Hertogenbosch, Netherlands, 5211 NL | |
Leiden University Medical Center | |
Leiden, Netherlands, 2300 RC | |
Onze Lieve Vrouwe Gasthuis | |
Amsterdam, Netherlands, 1091 HA | |
Universitair Medisch Centrum St. Radboud - Nijmegen | |
Nijmegen, Netherlands, NL-6500 HB |
Investigator: | Sergio Amadori, MD | Ospedale Sant' Eugenio |
Investigator: | Petra Muus, MD, PhD | Universitair Medisch Centrum St. Radboud - Nijmegen |
Study Chair: | Giuliana Alimena | Universita Degli Studi "La Sapeinza" |
Study ID Numbers: | CDR0000385671, EORTC-06031 |
Study First Received: | September 7, 2004 |
Last Updated: | January 10, 2009 |
ClinicalTrials.gov Identifier: | NCT00091234 |
Health Authority: | United States: Federal Government |
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) untreated adult acute myeloid leukemia secondary acute myeloid leukemia adult acute basophilic leukemia adult acute eosinophilic leukemia adult erythroleukemia (M6a) |
adult pure erythroid leukemia (M6b) adult acute megakaryoblastic leukemia (M7) adult acute minimally differentiated myeloid leukemia (M0) adult acute monoblastic leukemia (M5a) adult acute monocytic leukemia (M5b) adult acute myeloblastic leukemia with maturation (M2) adult acute myeloblastic leukemia without maturation (M1) adult acute myelomonocytic leukemia (M4) |
Leukemia, Monocytic, Acute Acute myelogenous leukemia Acute myelomonocytic leukemia Leukemia, Myeloid Gemtuzumab Leukemia, Myeloid, Acute Di Guglielmo's syndrome Antibodies, Monoclonal Leukemia, Myelomonocytic, Acute Leukemia |
Antibodies Leukemia, Erythroblastic, Acute Neoplasm Metastasis Acute erythroblastic leukemia Acute myeloid leukemia, adult Congenital Abnormalities Acute monoblastic leukemia Acute myelocytic leukemia Immunoglobulins |
Neoplasms Neoplasms by Histologic Type Immunologic Factors Antineoplastic Agents |
Therapeutic Uses Physiological Effects of Drugs Pharmacologic Actions |