Treatment of Acute Myeloblastic Leukemia in Younger Patients

This study has been completed.
Sponsor:
Information provided by:
PETHEMA Foundation
ClinicalTrials.gov Identifier:
NCT00390715
First received: October 18, 2006
Last updated: March 11, 2010
Last verified: March 2010
  Purpose

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


Condition Intervention Phase
Acute Myeloblastic Leukemia
Drug: chemotherapy
Phase 4

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Prospective Study of the Value of the Cytogenetic and of the Monitoring of the Minimal Residual Disease

Resource links provided by NLM:


Further study details as provided by PETHEMA Foundation:

Estimated Enrollment: 600
Study Start Date: January 1999
Study Completion Date: January 2010
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   up to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

AML of new diagnose, no treated previously

Criteria

Inclusion Criteria:

  • Age< or =65 years.
  • ECOG<=3.
  • AML of new diagnose.
  • Consent for chemotherapy.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00390715

Locations
Spain
Xarxa assistencial de Manresa
Manresa, Barcelona, Spain
Hospital general de Castellón
Castello, Castellón, Spain
Hospital Universitario de Canarias
Tenerife, Islas Canarias, Spain
Complejo Hospitalario Universitario de Santiago
Santiago de Compostela, La Coruña, Spain
Clínica Universitaria de Navarra
Pamplona, Navarra, Spain
Hospital Verge de la Cinta
Tortosa, Tarragona, Spain
Hospital General de Alicante
Alicante, Spain
Hospital Valle Hebrón-Materno Infantil
Barcelona, 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
Complejo Hospitalario de Cáceres
Cáceres, Spain
Hospital Puerta del Mar
Cádiz, 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 Universitario de la Princesa
Madrid, Spain
Hospital General Universitario Gregorio Marañón, Madrid
Madrid, Spain
Hospital General Universitario Morales Meseguer.
Murcia, Spain
. Hospital Clínico Universitario Virgen de la Victoria
Málaga, Spain
Hospital Central de Asturias
Oviedo, Spain
Hospital Son Dureta
Palma de Mallorca, Spain
Hospital Clínico Universitario de Salamanca
Salamanca, Spain
Hospital Universitario Marqués de Valdecilla
Santander, Spain
Hospital General de Segovia
Segovia, Spain
Hospital Universitario Virgen del Rocío
Sevilla, Spain
Hospital Universitari de Tarragona Joan XXIII
Tarragona, Spain
Hospital La Fe
Valencia, Spain
Hospital Clínic
Valencia, Spain
Hospital Universitario Dr. Peset
Valencia, Spain
Complejo Hospitalario Xeral-Cies
Vigo, Spain
Hospital Txagorritxu
Vitoria, Spain
Hospital Clínico Lozano Blesa
Zaragoza, Spain
Sponsors and Collaborators
PETHEMA Foundation
Investigators
Study Chair: Diaz Mediavilla Joaquin, Dr Hospital Clínico Universitario San Carlos
  More Information

Additional Information:
No publications provided

Responsible Party: Pethema, pethema
ClinicalTrials.gov Identifier: NCT00390715     History of Changes
Other Study ID Numbers: AML99<=65 años
Study First Received: October 18, 2006
Last Updated: March 11, 2010
Health Authority: Spain: Ministry of Health

Keywords provided by PETHEMA Foundation:
Acute Myeloblastic Leukemia

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Neoplasm, Residual
Neoplasms by Histologic Type
Neoplasms
Neoplastic Processes
Pathologic Processes

ClinicalTrials.gov processed this record on April 16, 2014