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Treatment of Acute Myeloblastic Leukemia in Younger Patients

NCT ID: NCT00390715

Last Updated: 2010-03-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

600 participants

Study Classification

OBSERVATIONAL

Study Start Date

1999-01-31

Study Completion Date

2010-01-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Acute Myeloblastic Leukemia

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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chemotherapy

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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PETHEMA Foundation

OTHER

Sponsor Role lead

Responsible Party

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pethema

Principal Investigators

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Diaz Mediavilla Joaquin, Dr

Role: STUDY_CHAIR

Hospital Clínico Universitario San Carlos

Locations

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Hospital General de Alicante

Alicante, Alicante, Spain

Site Status

Hospital Clínic

Barcelona, Barcelona, Spain

Site Status

Hospital de la Santa Creu i Sant Pau

Barcelona, Barcelona, Spain

Site Status

Hospital del Mar

Barcelona, Barcelona, Spain

Site Status

Hospital Germans Trias i Pujol

Barcelona, Barcelona, Spain

Site Status

Hospital vall d'Hebrón

Barcelona, Barcelona, Spain

Site Status

Hospital Valle Hebrón-Materno Infantil

Barcelona, Barcelona, Spain

Site Status

Xarxa assistencial de Manresa

Manresa, Barcelona, Spain

Site Status

Hospital Universitario de Canarias

Santa Cruz de Tenerife, Canary Islands, Spain

Site Status

Hospital Universitario Marqués de Valdecilla

Santander, Cantabria, Spain

Site Status

Hospital general de Castellón

Castelló, Castellón, Spain

Site Status

Hospital Puerta del Mar

Cadiz, Cádiz, Spain

Site Status

Complejo Hospitalario Reina Sofía

Córdoba, Córdoba, Spain

Site Status

Hospital Universitario Virgen de las Nieves

Granada, Granada, Spain

Site Status

Hospital Virgen de las Nieves

Granada, Granada, Spain

Site Status

Hospital Juan Canalejo

A Coruña, La Coruña, Spain

Site Status

Complejo Hospitalario Universitario de Santiago

Santiago de Compostela, La Coruña, Spain

Site Status

Fundación Jiménez Díaz

Madrid, Madrid, Spain

Site Status

Hospital Clínico San Carlos de Madrid

Madrid, Madrid, Spain

Site Status

Hospital Doce de Octubre

Madrid, Madrid, Spain

Site Status

Hospital General Universitario Gregorio Marañón, Madrid

Madrid, Madrid, Spain

Site Status

Hospital Universitario de la Princesa

Madrid, Madrid, Spain

Site Status

Hospital General Universitario Morales Meseguer.

Murcia, Murcia, Spain

Site Status

. Hospital Clínico Universitario Virgen de la Victoria

Málaga, Málaga, Spain

Site Status

Clínica Universitaria de Navarra

Pamplona, Navarre, Spain

Site Status

Hospital Central de Asturias

Oviedo, Oviedo, Spain

Site Status

Hospital Son Dureta

Palma de Mallorca, Palma de Mallorca, Spain

Site Status

Hospital Universitario Virgen del Rocío

Seville, Sevilla, Spain

Site Status

Hospital Universitari de Tarragona Joan XXIII

Tarragona, Tarragona, Spain

Site Status

Hospital Verge de la Cinta

Tortosa, Tarragona, Spain

Site Status

Hospital Clínic

Valencia, Valencia, Spain

Site Status

Hospital La Fe

Valencia, Valencia, Spain

Site Status

Hospital Universitario Dr. Peset

Valencia, Valencia, Spain

Site Status

Complejo Hospitalario Xeral-Cies

Vigo, Vigo, Spain

Site Status

Hospital Clínico Lozano Blesa

Zaragoza, Zaragoza, Spain

Site Status

Complejo Hospitalario de Cáceres

Cáceres, , Spain

Site Status

Area Hospitalaria Juan Ramón Jimenez

Huelva, , Spain

Site Status

Hospital general de Jerez de la Frontera

Jerez de la Frontera, , Spain

Site Status

Hospital Virgen Blanca de León

León, , Spain

Site Status

Hospital Clínico Universitario de Salamanca

Salamanca, , Spain

Site Status

Hospital General de Segovia

Segovia, , Spain

Site Status

Hospital Txagorritxu

Vitoria-Gasteiz, , Spain

Site Status

Countries

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Spain

Related Links

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http://www.aehh.org

Spanish association of Haematology

Other Identifiers

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AML99<=65 años

Identifier Type: -

Identifier Source: org_study_id

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