Treatment of Newly Diagnosed Patients With Acute Promyelocytic Leukemia (PETHEMA LPA 2005)

PHASE4CompletedINTERVENTIONAL
Enrollment

300

Participants

Timeline

Start Date

July 31, 2005

Primary Completion Date

April 30, 2012

Study Completion Date

December 31, 2013

Conditions
Acute Promyelocytic Leukemia
Interventions
DRUG

ATRA

45 mg/m2 day until CR Consolidation: 3 cycles (45 mg/m2 days 1-15) Maintenance:15 days every 3 months

DRUG

Idarubicina

Induction: 12 mg/m2 days 2, 4, 6 and 8 Consolidation: 5 mg/m2 days 1-4 in cycle 1 and 12 mg/m2 day 1 in cycle 3.

DRUG

Mitoxantrone

Consolidation: Mitoxantrone 10 mg/m2 days 1-3 in cycle 2

DRUG

ARA-C

In high risk patients, consolidation with ara-C in cycles 1 and 3.

Trial Locations (42)

Unknown

PALG, Lodz

Hospital Juan Canalejo, A Coruña

Hospital General, Albacete

Hospital general, Alicante

Hospital germans Trias i Pujol, Badalona

Hospital Clinic, Barcelona

Hospital de Sant Pau, Barcelona

Institut Català d'Oncologái, Barcelona

Basurtuko Ospitalea, Bilbao

Hospital general, Castellon

Hospital de Fuenlabrada, Fuenlabrada

"Hospital Dr. Trueta", Girona

Hospital de Jerez de la Frontera, Jerez de la Frontera

Hospital Insular de las Palmas, Las Palmas de Gran Canaria

Complejo Hospitalario León, León

Complexo Hospitalario Xeral-Calde, Lugo

Hospital 12 de Octubre, Madrid

Hospital Clínico San Carlos, Madrid

Hospital Puerta de Hierro, Madrid

Hospital Reina Sofia, Madrid

Hospital San Pedro de Alcántara, Madrid

Hospital Severo Ochoa, Madrid

H. Carlos Haya, Málaga

H. Universitario Virgen de la Victoria, Málaga

Hospital Sta. Maria del Rosell, Murcia

Hospital Central de Asturias, Oviedo

Hospital Dr Negrín, Palma de Gran Canaria

Hospital de Navarra, Pamplona

Hospital de Montecelo, Pontevedra

Hospital Clínico Universitario, Salamanca

Hospital de Cruces, Santander

Hospital de Santiago de Compostela, Santiago de Compostela

H.U. Virgen del Rocio, Seville

Hospital Joan XXIII, Tarragona

Hospital Dr. Peset, Valencia

Hospital general, Valencia

Hospital La Fe, Valencia

Hospital Clínico de Valladolid, Valladolid

Hospital Txagorritxu, Vitoria-Gasteiz

Hospital Virgen de la Concha, Zamora

Hospital Clínico Universitario Lozano Blesa, Zaragoza

Hospital Maciel, Montevideo

All Listed Sponsors
lead

PETHEMA Foundation

OTHER

NCT00408278 - Treatment of Newly Diagnosed Patients With Acute Promyelocytic Leukemia (PETHEMA LPA 2005) | Biotech Hunter | Biotech Hunter