PETHEMA-LMA10: Treatment of Acute Myeloblastic Leukemia (AML) in Patients Less Than or Equal to 65 Years
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|ClinicalTrials.gov Identifier: NCT01296178|
Recruitment Status : Recruiting
First Posted : February 15, 2011
Last Update Posted : October 26, 2017
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
|Condition or disease||Intervention/treatment||Phase|
|Acute Myeloblastic Leukemia||Drug: IDARUBICINE Drug: ARA-C||Not Applicable|
- 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.
- Apply a uniform treatment to individual patients according to previously defined prognostic groups.
- Correlate the different clinical and biological characteristics with response rates and patient outcomes.
- Studying the role of minimal residual disease by molecular techniques in anticipation of relapse of AML
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||PROTOCOL FOR First Line TREATMENT ADAPTED TO RISK of Acute Myeloblastic Leukemia in Patients LESS THAN OR EQUAL TO 65 YEARS|
|Study Start Date :||December 2010|
|Estimated Primary Completion Date :||May 2018|
|Estimated Study Completion Date :||December 2018|
Administration of chemotherapy induction
Idarubicin IV Dose of 12 mg/m2/day days 1 to 3
- Number of survival months in treated AML patients less or equal to 65 years as a measure of survival time [ Time Frame: 2 years ]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
- Patients classification in prognostic groups [ Time Frame: 2 years ]Patients classification in prognostic groups and aplication of individual treatments.
- Response rates [ Time Frame: 2 years ]Correlate the different clinical and biological characteristics with response rates and patient outcomes
- Determinate the minimal residual disease [ Time Frame: 2 years ]Studying the role of minimal residual disease by molecular techniques in anticipation of relapse of AML
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01296178
|Contact: Federico Moscardó, Dr||+34 firstname.lastname@example.org|
|Hospital La Fe||Recruiting|
|Contact: Federico Moscardó, Dr email@example.com|