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NCT00390715 Clinical Trial

Treatment of Acute Myeloblastic Leukemia in Younger Patients

Acute Myeloblastic Leukemia Clinical Trial

Official title:
Prospective Study of the Value of the Cytogenetic and of the Monitoring of the Minimal Residual Disease

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00390715
Other study ID # AML99<=65 años
Secondary ID
Status Completed
Phase Phase 4
First received October 18, 2006
Last updated March 11, 2010
Start date January 1999
Est. completion date January 2010

Study information
Verified date March 2010
Source PETHEMA Foundation
Contact n/a
Is FDA regulated No
Health authority Spain: Ministry of Health
Study type Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 600
Est. completion date January 2010
Est. primary completion date December 2007
Accepts healthy volunteers No
Gender Both
Age group N/A to 65 Years
Eligibility Inclusion Criteria:

- Age< or =65 years.

- ECOG<=3.

- AML of new diagnose.

- Consent for chemotherapy.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Drug:
• chemotherapy

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

Sponsors (1)
Lead Sponsor Collaborator
PETHEMA Foundation

Country where clinical trial is conducted

Spain, 

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