Ignite Creation Date:
2024-05-05 @ 11:17 PM
Last Modification Date:
2024-10-26 @ 10:31 AM
Study NCT ID:
NCT01296178
Status:
UNKNOWN
Last Update Posted:
2021-03-23
First Post:
2011-02-09
Brief Title:
PETHEMA-LMA10 Treatment of Acute Myeloblastic Leukemia AML in Patients Less Than or Equal to 65 Years
Sponsor:
PETHEMA Foundation
Organization:
PETHEMA Foundation
Study Overview
Official Title:
PROTOCOL FOR First Line TREATMENT ADAPTED TO RISK of Acute Myeloblastic Leukemia in Patients LESS THAN OR EQUAL TO 65 YEARS
Status:
UNKNOWN
Status Verified Date:
2021-03
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None