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Treatment of Acute Myeloblastic Leukemia in Younger Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00390715
First Posted: October 20, 2006
Last Update Posted: March 15, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
PETHEMA Foundation
October 18, 2006
October 20, 2006
March 15, 2010
January 1999
December 2007   (Final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00390715 on ClinicalTrials.gov Archive Site
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Treatment of Acute Myeloblastic Leukemia in Younger Patients
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.
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.
Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Non-Probability Sample
AML of new diagnose, no treated previously
Acute Myeloblastic Leukemia
Drug: chemotherapy
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
600
January 2010
December 2007   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age< or =65 years.
  • ECOG<=3.
  • AML of new diagnose.
  • Consent for chemotherapy.
Sexes Eligible for Study: All
up to 65 Years   (Child, Adult)
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
 
NCT00390715
AML99<=65 años
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Pethema, pethema
PETHEMA Foundation
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Study Chair: Diaz Mediavilla Joaquin, Dr Hospital Clínico Universitario San Carlos
PETHEMA Foundation
March 2010