NCT01296178

PETHEMA-LMA10: Treatment of Acute Myeloblastic Leukemia (AML) in Patients Less Than or Equal to 65 Years

PROTOCOL FOR First Line TREATMENT ADAPTED TO RISK of Acute Myeloblastic Leukemia in Patients LESS THAN OR EQUAL TO 65 YEARS

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: PETHEMA Foundation · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

Primary objectives 1. 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. Apply a uniform treatment to individual patients according to previously defined prognostic groups. Secondary Objectives 1. Correlate the different clinical and biological characteristics with response rates and patient outcomes. 2. Studying the role of minimal residual disease by molecular techniques in anticipation of relapse of AML

Conditions

• Acute Myeloblastic Leukemia

Interventions

Type	Name	Description
DRUG	IDARUBICINE	Administration of chemotherapy induction Idarubicin IV Dose of 12 mg/m2/day days 1 to 3
DRUG	ARA-C	ARA-C 200 mg/m2/day dose continuous infusion of IV days 1 to 7

Timeline

• Start date: 2010-12-01
• Primary completion: 2021-12-01
• Completion: 2021-12-01
• First posted: 2011-02-15
• Last updated: 2021-03-23

Locations

1 site across 1 country: Spain