Risk Adapted Treatment for Primary Acute Myeloid Leukemia (AML)

PHASE2CompletedINTERVENTIONAL
Enrollment

862

Participants

Timeline

Start Date

October 31, 2003

Primary Completion Date

March 31, 2012

Study Completion Date

March 31, 2012

Conditions
Leukemia, Myelocytic, Acute
Interventions
DRUG

Ara-C

"* Intermediate dose during induction phase to remission.~* High dose during consolidation phase in patients with favorable cytogenetics and leukocyte index below 20."

OTHER

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."

OTHER

Allogeneic matched related or unrelated donor transplant.

-Patients without favorable/intermediate characteristics.

DRUG

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."

OTHER

CD34+ selection.

-Patients with adverse prognosis with allogeneic peripheral blood stem cell (PBSC)tranplantation, CD34+ cell selection of the inoculum was performed.

OTHER

Mylotarg purging before autologous PBSC transplantation

Patients without favorable/intermediate characteristics and without matched related donor.

Trial Locations (21)

15006

Hospital A Coruña, A Coruña

17007

Hopital Universitari de Girona Dr. Josep Trueta, Girona

25006

Hospital Universitari Arnau de Vilanova, Lleida

28046

Hospital Universitario La Paz, Madrid

29010

Hospital Universitario Virgen de la Victoria, Málaga

30008

Hospital General Universitario de Murcia, Murcia

41010

Hospital Universitario Rio Hortega, Valladolid

41014

Hospital Universitario Virgen del Rocio, Seville

43007

Hospital Universitari Joan XXIII, Tarragona

43517

Hospital Verge de la Cinta, Tortosa

46010

Hospital Clinico Universitario de Valencia, Valencia

08916

Hospital Universitari Germans Trias i Pujol, Badalona

08003

Hospital del Mar, Barcelona

08022

Centro Medico Teknon, Barcelona

08025

Hospital de la Santa Creu i Sant Pau, Barcelona

08035

Hospital Vall d'Hebron, Barcelona

08036

Hospital Clínic de Barcelona, Barcelona

08907

ICO Hospital Universitari de Bellvitge, L'Hospitalet Del Llobregat

07198

Hospital Universitari Son Espases, Palma de Mallorca

Unknown

Hospital Universitari Son Dureta, Palma de Mallorca

08225

Mutua de Terrassa, Terrassa

All Listed Sponsors
lead

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

OTHER

NCT01723657 - Risk Adapted Treatment for Primary Acute Myeloid Leukemia (AML) | Biotech Hunter | Biotech Hunter