862
Participants
Start Date
October 31, 2003
Primary Completion Date
March 31, 2012
Study Completion Date
March 31, 2012
Ara-C
"* Intermediate dose during induction phase to remission.~* High dose during consolidation phase in patients with favorable cytogenetics and leukocyte index below 20."
Autologous peripheral blood stem cell transplantation.
"* In patients with favorable cytogenetics with a Leukocyte index above 20.~* Patients with normal karyotype, and one cycle of chemotherapy to achieve complete remission, without adverse molecular and/or minimal residual disease (MRD) characteristics, regardless availability of a matched donor."
Allogeneic matched related or unrelated donor transplant.
-Patients without favorable/intermediate characteristics.
G-CSF
"* Administration at induction phase to remission, days 0 to 7. G-CSF will not be initiated if the leukocyte count is over 30x10e9/L at diagnosis or will be interrupted if the leukocyte count during treatmen arises 30x10e9/L.~* Administration at consolidation phase, days 4 to 6 (3 doses). G-CSF will be interrupted if the leukocyte count during treatment arises 30x10e9/L."
CD34+ selection.
-Patients with adverse prognosis with allogeneic peripheral blood stem cell (PBSC)tranplantation, CD34+ cell selection of the inoculum was performed.
Mylotarg purging before autologous PBSC transplantation
Patients without favorable/intermediate characteristics and without matched related donor.
Hospital A Coruña, A Coruña
Hopital Universitari de Girona Dr. Josep Trueta, Girona
Hospital Universitari Arnau de Vilanova, Lleida
Hospital Universitario La Paz, Madrid
Hospital Universitario Virgen de la Victoria, Málaga
Hospital General Universitario de Murcia, Murcia
Hospital Universitario Rio Hortega, Valladolid
Hospital Universitario Virgen del Rocio, Seville
Hospital Universitari Joan XXIII, Tarragona
Hospital Verge de la Cinta, Tortosa
Hospital Clinico Universitario de Valencia, Valencia
Hospital Universitari Germans Trias i Pujol, Badalona
Hospital del Mar, Barcelona
Centro Medico Teknon, Barcelona
Hospital de la Santa Creu i Sant Pau, Barcelona
Hospital Vall d'Hebron, Barcelona
Hospital Clínic de Barcelona, Barcelona
ICO Hospital Universitari de Bellvitge, L'Hospitalet Del Llobregat
Hospital Universitari Son Espases, Palma de Mallorca
Hospital Universitari Son Dureta, Palma de Mallorca
Mutua de Terrassa, Terrassa
Grupo Cooperativo de Estudio y Tratamiento de las Leucemias Agudas y Mielodisplasias
OTHER