Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase IV Biomarker/Laboratory analysis, Treatment Closed 65 and under Other AML99<=65 años NCT00390715

Trial Description

Summary

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

Further Study Information

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 Criteria

Inclusion Criteria:

• Age< or =65 years.

• ECOG<=3.

• AML of new diagnose.

• Consent for chemotherapy.

Exclusion Criteria:

• Previous chemotherapy.

• AML-M3.

• Blastic crisis CML.

• AML 2ª to SMPC or SMD.

• Associated active Neoplasia.

• Serious psychiatric disease.

• Contraindication to receive chemotherapy.

• Creatinine >2.5 mg/dL Bilirubin>3x values of high limit of normality.

• Positivity of test of pregnancy or antibodies VIH.

NOTE: All the patients with AML will register themselves, although they do not fulfill the criteria indicated, to be able to evaluate better the studied population

Trial Contact Information

Trial Lead Organizations/Sponsors

Program for the Study and Treatment of Hematological Malignancies

Diaz Mediavilla Joaquin, Dr

Study Chair

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00390715
Information obtained from ClinicalTrials.gov on July 16, 2008