Risk-adapted Therapy for Primary Acute Myeloid Leukemia

PHASE2CompletedINTERVENTIONAL
Enrollment

1,034

Participants

Timeline

Start Date

February 1, 2012

Primary Completion Date

July 31, 2022

Study Completion Date

November 10, 2022

Conditions
Leukemia, Myeloid, Acute
Interventions
DRUG

Idarubicin

12 mg/m2/day; intravenous, administration at induction phase, days 1 to 3.

DRUG

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."

DRUG

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."

PROCEDURE

Allogeneic matched or unrelated donor transplant.

To be performed in patients in the intermediate or adverse risk groups.

PROCEDURE

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.

PROCEDURE

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.

Trial Locations (15)

17007

ICO-Girona Hopital Universitari de Girona Dr. Josep Trueta, Girona

25006

Hospital Universitari Arnau de Vilanova, Lleida

29010

Hospital Universitario Virgen de la Victoria, Málaga

43007

ICO Tarragona-Hospital Universitari Joan XXIII, Tarragona

43517

Hospital Verge de la Cinta, Tortosa

496010

Hospital Clínico Universitario de Valencia, Valencia

08916

ICO Badalona-Hospital Universitari Germans Trias i Pujol, Badalona

08907

ICO Hospital Universitari de Bellvitge, L'Hospitalet de Llobregat

07198

Hospital Universitari Son Espases, Palma de Mallorca

Unknown

Hospital Universitari Son Llatzer, Palma de Mallorca

08003

Hospital del Mar, Barcelona

08025

Hospital de la Santa Creu i Sant Pau, Barcelona

08035

Hospital Vall d'Hebron, Barcelona

08036

Hospital Clinic Barcelona, Barcelona

08225

Mutua de Terrassa, Terrassa

All Listed Sponsors
lead

Grupo Cooperativo de Estudio y Tratamiento de las Leucemias Agudas y Mielodisplasias

OTHER

NCT04687098 - Risk-adapted Therapy for Primary Acute Myeloid Leukemia | Biotech Hunter | Biotech Hunter