| Trial Status | Recruiting |
| Dates | Date of activation: 28-Jun-04 |
| Data management at EORTC | Full |
| Phase | 2-3 |
| Randomized trial | Yes |
| Type | Hemato-malign |
| Targeted Sample size | EORTC Groups: 75 - All Groups: 267 |
| Number of steps | 1 |
| Drug | Gemtuzumab |
| Study Staff | Sergio Amadori (Study Coordinator) - Azienda Ospedallera Universitaria - Policlinico Tor Vergata, Roma Stefan Suciu (Statistician) - EORTC Headquarters, Brussels Séraphine Rossi (Data Manager) - EORTC Headquarters, Brussels Safaa Ramadan (Coordinating Physician) - EORTC Headquarters, Brussels Hilde Breyssens (Project Manager) - EORTC Headquarters, Brussels, hilde.breyssens( at )eortc.be, +32 27741004 |
| Type of cancer | Acute Myelogenous Leukemia |
| Participating Groups | EORTC Leukemia Group(Coordinating Group) Gruppo Italiano Malattie Ematologiche dell'Adulto |
| Centers authorized by EORTC | Hôpitaux Universitaires Bordet-Erasme - Institut Jules Bordet (Brussels, Belgium) - Inst. 101 A.Z. St. Jan (Brugge, Belgium) - Inst. 109 ZNA Middelheim (Antwerpen, Belgium) - Inst. 114 Universitair Ziekenhuis Antwerpen (Edegem, Belgium) - Inst. 117 Centre Hospitalier Peltzer-La Tourelle (Verviers, Belgium) - Inst. 118 Hôpitaux Universitaires Bordet-Erasme - Hopital Universitaire Erasme (Brussels, Belgium) - Inst. 131 C.H.U. Sart-Tilman (Liege, Belgium) - Inst. 155 Amedeo Avogadro University of Eastern Piedmont-Ospedale Maggiore della Carita (Novara, Italy) - Inst. 9006 Ospedale Castelfranco Veneto (Castelfranco Veneto, Italy) - Inst. 166 Ospedale San Eugenio (Roma, Italy) - Inst. 692 Azienda Ospedaliera Di Parma (Parma, Italy) - Inst. 696 Ospedale Sta Maria Delle Croci (Ravenna, Italy) - Inst. 701 Ospedale Maggiore (Trieste, Italy) - Inst. 716 Ospedale S. Donato, USL -8 (Arezzo Cap, Italy) - Inst. 3936 Universita Di Roma La Sapienza - Universita Degli Studi Di Roma La Sapienza - Ospedale Sant'Andrea (Roma, Italy) - Inst. 3944 Asl8 - Ospedale R. Binaghi (Cagliari, Italy) - Inst. 8968 Azienda Ospedaliera Vito Fazzi (Lecce, Italy) - Inst. 9039 Libero Istituto Universitario Campus Bio-Medico (Roma, Italy) - Inst. 3903 H. San Giovanni - Addolorata (Roma, Italy) - Inst. 3904 Universita Degli Studi Di Siena -Policlinico "le Scotte" (Siena, Italy) - Inst. 3922 La Maddalena S.P.A. (Palermo, Italy) - Inst. 3923 Azienda Ospedallera Universitaria - Policlinico Tor Vergata (Roma, Italy) - Inst. 3931 Ospedale Civile Umberto I (Nocera Inferiore, Italy) - Inst. 3934 Ospedale San Carlo (Potenza, Italy) - Inst. 819 Ospedale A. Cardarelli (Napoli, Italy) - Inst. 820 Universita Di Modena e Reggio Emilia C.O.M. - Centro Oncologico Modenese (Modena, Italy) - Inst. 825 Istituto Di Ematologia - Universita Di Sassari (Sassari, Italy) - Inst. 828 Universita Di Ferrara - Ospedale S. Anna (Ferrara, Italy) - Inst. 3875 Ospedale Di Montefiascone (Montefiascone, Italy) - Inst. 3896 Universita Degli Studi Di Bari - Policlinico (Bari, Italy) - Inst. 793 Ospedale Regionale A. Pugliese (Catanzaro, Italy) - Inst. 794 Ospedale Ferrarotto (Catania, Italy) - Inst. 799 Ospedale Oncologico A. Businco (Cagliari, Italy) - Inst. 814 Ospedale Civile Pescara (Pescara, Italy) - Inst. 816 Policlinico P. Giaccone - Universita Di Palermo (Palermo, Italy) - Inst. 818 Universita Di Roma La Sapienza - Clinica Ematologica dell'Università di Roma "La Sapienza" (Roma, Italy) - Inst. 733 Universita Di Brescia (Brescia, Italy) - Inst. 741 Istituto Regina Elena (Roma, Italy) - Inst. 742 Policlinico Monteluce (Perugia, Italy) - Inst. 744 Policlinico Universitario A. Gemelli - Universita Del Sacro Cuore (Roma, Italy) - Inst. 777 Ospedale San Salvatore (Pesaro, Italy) - Inst. 792 Jeroen Bosch Ziekenhuis ('s-Hertogenbosch, The Netherlands) - Inst. 22 Radboud University Nijmegen Medical Centre (Nijmegen, The Netherlands) - Inst. 304 Onze Lieve Vrouw Gasthuis (Amsterdam, The Netherlands) - Inst. 309 Leiden University Medical Centre (Leiden, The Netherlands) - Inst. 310 |
| Protocol summary | Cancer.gov (PDQ) ClinicalTrials.gov |
| NCT number | NCT00091234 |
| EudraCT | 2004-004356-39 |
| Protocol documents in PDF (requires password) | Study documentation |