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Treatment of Acute Myeloblastic Leukemia in Younger Patients
This study is ongoing, but not recruiting participants.
Sponsored by: PETHEMA Foundation
Information provided by: PETHEMA Foundation
ClinicalTrials.gov Identifier: NCT00390715
  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 IV

MedlinePlus related topics: Leukemia, Adult Acute Leukemia, Adult Chronic Leukemia, Childhood
U.S. FDA Resources
Study Type: Observational
Study Design: Case-Only, Prospective
Official Title: Prospective Study of the Value of the Cytogenetic and of the Monitoring of the Minimal Residual Disease

Further study details as provided by PETHEMA Foundation:

Biospecimen Retention:   None Retained

Biospecimen Description:

Estimated Enrollment: 600
Study Start Date: January 1999
Estimated Study Completion Date: January 2008
Estimated 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

  Show 42 Study Locations
Sponsors and Collaborators
PETHEMA Foundation
Investigators
Study Chair: Diaz Mediavilla Joaquin, Dr Hospital Clínico Universitario San Carlos
  More Information

Pethema Foundation web  This link exits the ClinicalTrials.gov site
Spanish association of Haematology  This link exits the ClinicalTrials.gov site

Responsible Party: pethema ( Pethema )
Study ID Numbers: AML99<=65 años
Study First Received: October 18, 2006
Last Updated: November 14, 2008
ClinicalTrials.gov Identifier: NCT00390715  
Health Authority: Spain: Ministry of Health

Keywords provided by PETHEMA Foundation:
Acute Myeloblastic Leukemia

Study placed in the following topic categories:
Neoplasm, Residual
Leukemia
Acute myelogenous leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Acute myelocytic leukemia

Additional relevant MeSH terms:
Neoplastic Processes
Neoplasms
Pathologic Processes
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on January 15, 2009