100
Participants
Start Date
January 31, 2003
Primary Completion Date
November 30, 2012
Study Completion Date
December 31, 2012
Vincristine
Vincristine (VCR): 1.5 mg/m2 (max 2 mg) IV d 1, 8, 15, 22 in induction VCR 2 mg, IV, d 1,8 in consolidation (cycle 1, 2)
Daunorubicin
Daunorubicin (DNR): 60 mg/m2 IV d 1, 8, 15, 22
Prednisone
Prednisone (PDN): 60 mg/m2/d IV or PO, d 1-28
Mitoxantrone
Mitoxantrone:12 mg/m2, IV d 15-17 in induction 12 mg/m2, IV,d 5 in cycle 2 consolidation
Cytosine Arabinoside
ARA-C 2,000 mg/m2/12h IV, d18,19 (4 doses) in induction
Dexamethasone
Dexamethasone 20 mg/m2,IV, d 1-5,10 mg/m2,IV, d 6 and 5 mg/m2,IV, d 7 in Consolidation (3 cycles)
Methotrexate (MTX)
Methotrexate (MTX)3 g/m2,IV, d1 (24h)in consolidation, cycles 1 and 2 MTX (15 mg/m2/wk, IM)in maintenance MTX 15 mg, IT
Cytarabine
Cytarabine 2g/m2/12h, IV d5 in cycle 1 consolidation Cytarabine 2g/m2/12h, IV d 1,2 in cycle 3 consolidation Cytarabine 30 mg, intrathecal
ASP
ASP 25,000 IU/m2, IV, d5 in consolidation (cycle 1, 2, 3)
Mercaptopurine
Mercaptopurine 100 mg/m2, PO, d 1-5 in consolidation
Teniposide
Teniposide 150 mg/m2, IV d 3,4 in consolidation cycle 3
Hydrocortisone
Hydrocortisone 20 mg, IT d 1, 28, 49, 77, 105, 175, 203, 231, 259,287, 311 intrathecal
Hospital Juan Canalejo, A Coruña
Hospital General, Alicante
Hospital Germans Trias i Pujol, Badalona
Clínica Teknon, Barcelona
Hospital Clínic i Provincial, Barcelona
Hospital de Sant Pau, Barcelona
Hospital Duran y Reynals, Barcelona
Hospital Vall d'Hebrón, Barcelona
Hospital Puerta del Mar, Cadiz
Hospital General, Castellon
Hospital San Pedro de Alcántara, Cáceres
Hospital Josep Trueta, Girona
Hospital Universitario, Guadalajara
Hospital Xeral, Lugo
Hospital 12 de Octubre, Madrid
Hospital Clínico Universitario, Madrid
Hospital de Fuenlabrada, Madrid
Hospital Ramón y Cajal, Madrid
Hospital Carlos Haya, Málaga
Hospital Virgen de la Victoria, Málaga
Hospital Morales Messeguer, Murcia
Hospital Central de Asturias, Oviedo
Hospital Son Llàtzer, Palma de Mallorca
Clínica Universitaria de Navarra, Pamplona
Hospital Parc Taulí, Sabadell
Hospital Clínico Universitario, Salamanca
Hospital Marqués de Valdecilla, Santander
Hospital Xeral, Santiago
Hospital Virgen del Rocio, Seville
Hospital Joan XXIII, Tarragona
Hospital Mútua de Terrassa, Terrassa
Hospital Clínico Universitario, Valencia
Hospital Dr Pesset, Valencia
Hospital General, Valencia
Hospital La Fe, Valencia
Hospital Clínico, Valladolid
Hospital Virgen de la Concha, Zamora
Hospital Lozano Blesa, Zaragoza
PETHEMA Foundation
OTHER