Clinical trial NCT00390715: Treatment of Acute Myeloblastic Leukemia in Younger Patients
Official title: Prospective Study of the Value of the Cytogenetic and of the Monitoring of the Minimal Residual Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Myeloblastic Leukemia
Keywords: Acute Myeloblastic Leukemia
Lead sponsor: PETHEMA Foundation
Sponsor class: OTHER
First posted: 2006-10-20
Enrollment: 600
Sex: ALL
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: AML of new diagnose, no treated previously

Brief summary: study of the value of the cytogenetics and the monitoring of the residual minimum disease in the standard treatment of acute myeloblastic leukemia.

Detailed description: The treatment scheme is purely welfare and therefore it does not require any approval of ethical committees for his application. It gathers the basic ideas of the present treatment of the AML, with optional induction according to preference of each center with daunorubicin or Idarubicin (x3) associated to AraC (x7). The patients who reach CR consolidate with an identical cycle to the used one in the induction. Later (if pte has identical donor HLA, and as much it as their doctors has preference by this option) receive allogenic transplant. The other patients who reach CR receive two intensifications, one that AraC to intermediate dose contains and another one with autologous transplant, previous preparation with Busulfán, Etoposide and AraC. Later all antileucemic treatment is suspended until possible relapse. This scheme of treatment is accompanied by a valuation of the quality of the CR with traditional morphology, Immunocytometry and molecular genetic study and of a pursuit of residual minimum disease (EMR) using the same techniques.

Eligibility criteria: Inclusion Criteria:

* Age\< or =65 years.
* ECOG\<=3.
* AML of new diagnose.
* Consent for chemotherapy.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Manresa
country: Spain
facility: Xarxa assistencial de Manresa
state: Barcelona
city: Castello
country: Spain
facility: Hospital general de Castellón
state: Castellón
city: Tenerife
country: Spain
facility: Hospital Universitario de Canarias
state: Islas Canarias
city: Santiago de Compostela
country: Spain
facility: Complejo Hospitalario Universitario de Santiago
state: La Coruña
city: Pamplona
country: Spain
facility: Clínica Universitaria de Navarra
state: Navarra
city: Tortosa
country: Spain
facility: Hospital Verge de la Cinta
state: Tarragona
city: Alicante
country: Spain
facility: Hospital General de Alicante
city: Barcelona
country: Spain
facility: Hospital Clínic
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
city: Barcelona
country: Spain
facility: Hospital del Mar
city: Barcelona
country: Spain
facility: Hospital Germans Trias i Pujol
city: Barcelona
country: Spain
facility: Hospital vall d'Hebrón
city: Barcelona
country: Spain
facility: Hospital Valle Hebrón-Materno Infantil
city: Cáceres
country: Spain
facility: Complejo Hospitalario de Cáceres
city: Cádiz
country: Spain
facility: Hospital Puerta del Mar
city: Córdoba
country: Spain
facility: Complejo Hospitalario Reina Sofía
city: Granada
country: Spain
facility: Hospital Universitario Virgen de las Nieves
city: Granada
country: Spain
facility: Hospital Virgen de las Nieves
city: Huelva
country: Spain
facility: Area Hospitalaria Juan Ramón Jimenez
city: Jerez de la Frontera
country: Spain
facility: Hospital general de Jerez de la Frontera
city: La Coruña
country: Spain
facility: Hospital Juan Canalejo
city: Leon
country: Spain
facility: Hospital Virgen Blanca de León
city: Madrid
country: Spain
facility: Fundación Jiménez Díaz
city: Madrid
country: Spain
facility: Hospital Clínico San Carlos de Madrid
city: Madrid
country: Spain
facility: Hospital Doce de Octubre
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Marañón, Madrid
city: Madrid
country: Spain
facility: Hospital Universitario de la Princesa
city: Murcia
country: Spain
facility: Hospital General Universitario Morales Meseguer.
city: Málaga
country: Spain
facility: . Hospital Clínico Universitario Virgen de la Victoria
city: Oviedo
country: Spain
facility: Hospital Central de Asturias
city: Palma de Mallorca
country: Spain
facility: Hospital Son Dureta
city: Salamanca
country: Spain
facility: Hospital Clínico Universitario de Salamanca
city: Santander
country: Spain
facility: Hospital Universitario Marqués de Valdecilla
city: Segovia
country: Spain
facility: Hospital General de Segovia
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocío
city: Tarragona
country: Spain
facility: Hospital Universitari de Tarragona Joan XXIII
city: Valencia
country: Spain
facility: Hospital Clínic
city: Valencia
country: Spain
facility: Hospital La Fe
city: Valencia
country: Spain
facility: Hospital Universitario Dr. Peset
city: Vigo
country: Spain
facility: Complejo Hospitalario Xeral-Cies
city: Vitoria
country: Spain
facility: Hospital Txagorritxu
city: Zaragoza
country: Spain
facility: Hospital Clínico Lozano Blesa
Study officials:
affiliation: Hospital Clínico Universitario San Carlos
name: Diaz Mediavilla Joaquin, Dr
role: STUDY_CHAIR
References: