Treatment of Acute Myeloblastic Leukemia in Younger Patients

March 11, 2010 updated by: PETHEMA Foundation

Prospective Study of the Value of the Cytogenetic and of the Monitoring of the Minimal Residual Disease

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Alicante, Spain
        • Hospital General de Alicante
      • Barcelona, Spain
        • Hospital del Mar
      • Barcelona, Spain
        • Hospital de la Santa Creu i Sant Pau
      • Barcelona, Spain
        • Hospital Vall d'Hebron
      • Barcelona, Spain
        • Hospital Clínic
      • Barcelona, Spain
        • Hospital Germans Trias i Pujol
      • Barcelona, Spain
        • Hospital Valle Hebrón-Materno Infantil
      • Cáceres, Spain
        • Complejo Hospitalario de Caceres
      • Cádiz, Spain
        • Hospital Puerta del Mar
      • Córdoba, Spain
        • Complejo Hospitalario Reina Sofía
      • Granada, Spain
        • Hospital Universitario Virgen de las Nieves
      • Granada, Spain
        • Hospital Virgen de las Nieves
      • Huelva, Spain
        • Area Hospitalaria Juan Ramón Jimenez
      • Jerez de la Frontera, Spain
        • Hospital general de Jerez de la Frontera
      • La Coruña, Spain
        • Hospital Juan Canalejo
      • Leon, Spain
        • Hospital Virgen Blanca de León
      • Madrid, Spain
        • Hospital Clínico San Carlos de Madrid
      • Madrid, Spain
        • Fundacion Jimenez Diaz
      • Madrid, Spain
        • Hospital Doce de Octubre
      • Madrid, Spain
        • Hospital Universitario de la Princesa
      • Madrid, Spain
        • HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARANON, MADRID
      • Murcia, Spain
        • Hospital General Universitario Morales Meseguer.
      • Málaga, Spain
        • . Hospital Clínico Universitario Virgen de la Victoria
      • Oviedo, Spain
        • Hospital Central de Asturias
      • Palma de Mallorca, Spain
        • Hospital Son Dureta
      • Salamanca, Spain
        • Hospital Clínico Universitario de Salamanca
      • Santander, Spain
        • Hospital Universitario Marques de Valdecilla
      • Segovia, Spain
        • Hospital General de Segovia
      • Sevilla, Spain
        • Hospital Universitario Virgen del Rocio
      • Tarragona, Spain
        • Hospital Universitari de Tarragona Joan XXIII
      • Valencia, Spain
        • Hospital Universitario Dr. Peset
      • Valencia, Spain
        • Hospital La Fe
      • Valencia, Spain
        • Hospital Clínic
      • Vigo, Spain
        • Complejo Hospitalario Xeral-Cies
      • Vitoria, Spain
        • Hospital Txagorritxu
      • Zaragoza, Spain
        • Hospital Clinico Lozano Blesa
    • Barcelona
      • Manresa, Barcelona, Spain
        • Xarxa assistencial de Manresa
    • Castellón
      • Castello, Castellón, Spain
        • Hospital General de Castellon
    • Islas Canarias
      • Tenerife, Islas Canarias, Spain
        • Hospital Universitario de Canarias
    • La Coruña
      • Santiago de Compostela, La Coruña, Spain
        • Complejo Hospitalario Universitario de Santiago
    • Navarra
      • Pamplona, Navarra, Spain
        • Clinica Universitaria de Navarra
    • Tarragona
      • Tortosa, Tarragona, Spain
        • Hospital Verge de la Cinta

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 65 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

AML of new diagnose, no treated previously

Description

Inclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

PETHEMA Foundation

Investigators

  • Study Chair: Diaz Mediavilla Joaquin, Dr, Hospital Clinico Universitario San Carlos

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 1999

Primary Completion (Actual)

December 1, 2007

Study Completion (Actual)

January 1, 2010

Study Registration Dates

First Submitted

October 18, 2006

First Submitted That Met QC Criteria

October 19, 2006

First Posted (Estimate)

October 20, 2006

Study Record Updates

Last Update Posted (Estimate)

March 15, 2010

Last Update Submitted That Met QC Criteria

March 11, 2010

Last Verified

March 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AML99<=65 años

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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