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

October 18, 2006
March 11, 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.
Both
up to 65 Years
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

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP