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Advances in the biological characterization of AML can now make a proper estimate of the risk of recurrence and likelihood of survival of different groups of patients according to the expression of different disease parameters. Karyotype, the molecular alterations affecting genes FLT3, NPM1 and CEBPA, minimal residual disease by flow cytometry and response to first induction cycle are variables that must be taken into consideration when planning the treatment of first line from a patient with AML.
This breakthrough in the field of biology has not resulted yet in the development of new drugs really effective in the treatment of AML. Therefore, the core of the treatment continue to rely on the use of traditional chemotherapy combined or not with allogeneic hematopoietic stem cell. Both treatments differ in their antileukemic efficacy, higher in aloTPH, as well as their toxicity and procedure-related mortality, increased also in the aloTPH. These aspects should be added that most candidates aloTPH patients lack an HLA identical sibling donor forcing the search for alternative sources and hematopoietic stem cell donors. These transplants alternative, but are not committed to their antileukemic efficacy, it does have implied a greater toxicity. Therefore, the ultimate effectiveness of these procedures depends largely on the proper selection of candidates for the same.
While there is broad agreement in terms of induction chemotherapy using a combination of cytarabine with anthracycline, the choice of chemotherapy regimen is controversial postremisión today. In the poor prognosis of itself involve the LMA, patients classified as "favorable group" are acceptable disease-free survival with consolidation schemes involving high-dose cytarabine. For other patients appear to be inappropriate to combine cytarabine with an anthracycline, at least one cycle of consolidation, and raise the option of allogeneic different depending on prognostic markers
Primary objectives
Secondary Objectives
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IDARUBICINE | Drug | Administration of chemotherapy induction Idarubicin IV Dose of 12 mg/m2/day days 1 to 3 | ||
| ARA-C | Drug | ARA-C 200 mg/m2/day dose continuous infusion of IV days 1 to 7 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of survival months in treated AML patients less or equal to 65 years as a measure of survival time | Optimizing current treatment of AML based on the classification of patients into different risk groups according to parameters cytogenetic and molecular response to treatment and to analyze its effectiveness in terms of survival | 2 years |
| Patients classification in prognostic groups | Patients classification in prognostic groups and aplication of individual treatments. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Response rates | Correlate the different clinical and biological characteristics with response rates and patient outcomes | 2 years |
| Determinate the minimal residual disease | Studying the role of minimal residual disease by molecular techniques in anticipation of relapse of AML |
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Inclusion Criteria:
Left ventricular ejection fraction (LVEF) > 40% measured by echocardiography in multiport scanner acquisition (MUGA) or isotope angiography, or Left ventricular fractional shortening > 22% measured in echocardiography
Exclusion Criteria:
Left ventricular ejection fraction (LVEF) <40% measured by echocardiography in multiport scanner acquisition (MUGA) or isotope angiography, or Left ventricular fractional shortening <22% measured by echocardiography
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Federico Moscardó, Dr | Contact | +34 963862745 | fedemoscardo@yahoo.es |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital La Fe | Recruiting | Valencia | Spain |
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| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D015255 | Idarubicin |
| D003561 | Cytarabine |
| ID | Term |
|---|---|
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
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| 2 years |
| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006841 |
| Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001087 | Arabinonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |