1,034
Participants
Start Date
February 1, 2012
Primary Completion Date
July 31, 2022
Study Completion Date
November 10, 2022
Idarubicin
12 mg/m2/day; intravenous, administration at induction phase, days 1 to 3.
Ara-C
"200mg/m2/day, intravenous at induction phase; days 1-7.~\- High dose during consolidation phase. In patients up to 60 years 3g/m2/12hours days 1,3,5, and patients 60 to 70 years: 1.5g/m2/12hours days 1,3,5."
G-CSF
"* Administration at induction phase to remission days 1 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 treatment arises 30x10e9/L.~* Administration at consolidation phase day 7."
Allogeneic matched or unrelated donor transplant.
To be performed in patients in the intermediate or adverse risk groups.
Autologous peripheral blood stem cell transplant
To be considered in patients in the intermediate risk group without an available allogeneic donor and negative measurable residual disease, per center decision.
Measurable residual disease
To be performed either with molecular monitoring or, if not applicable, by flow cytometry. Pre-stablished cut-off values are defined for decision-making.
ICO-Girona Hopital Universitari de Girona Dr. Josep Trueta, Girona
Hospital Universitari Arnau de Vilanova, Lleida
Hospital Universitario Virgen de la Victoria, Málaga
ICO Tarragona-Hospital Universitari Joan XXIII, Tarragona
Hospital Verge de la Cinta, Tortosa
Hospital Clínico Universitario de Valencia, Valencia
ICO Badalona-Hospital Universitari Germans Trias i Pujol, Badalona
ICO Hospital Universitari de Bellvitge, L'Hospitalet de Llobregat
Hospital Universitari Son Espases, Palma de Mallorca
Hospital Universitari Son Llatzer, Palma de Mallorca
Hospital del Mar, Barcelona
Hospital de la Santa Creu i Sant Pau, Barcelona
Hospital Vall d'Hebron, Barcelona
Hospital Clinic Barcelona, Barcelona
Mutua de Terrassa, Terrassa
Grupo Cooperativo de Estudio y Tratamiento de las Leucemias Agudas y Mielodisplasias
OTHER