PROTOCOL FOR First Line TREATMENT ADAPTED TO RISK of Acute Myeloblastic Leukemia in Patients LESS THAN OR EQUAL TO 65 YEARS
N/A
65 Years
Both
Acute Myeloblastic Leukemia
Trial Information
PROTOCOL FOR First Line TREATMENT ADAPTED TO RISK of Acute Myeloblastic Leukemia in Patients LESS THAN OR EQUAL TO 65 YEARS
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
Inclusion Criteria:
- Diagnosis of AML according to WHO criteria
- Previously untreated AML, including AML de novo,AML secondary to MDS or previous
chemotherapy or radiotherapy
- No promyelocytic leukemia (no t (15, 17) or PML-RARa rearrangement and its variants)
- Age ≤ 65 years
- ECOG performance status 0-2
- Provide written informed consent
- Being able to comply with protocol procedures
- Not to be fertile or willing to use a method of birth control during treatment and
until the end of it
- Adequate renal and hepatic function as follows, provided the changes, which would be
not due to the disease: Total bilirubin < 1.5 x upper limit of normal (ULN)
institutional and AST and ALT < 2.5 x ULN, and Serum creatinine < 2.5 mg / dL.
- Adequate cardiac function determined by at least 1 of the following:
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:
- LPA diagnosis according to WHO criteria
- Previously untreated AML, except for the administration of hydroxyurea as a
cytoreductive agent which itself is permitted
- AML secondary to chronic myeloproliferative syndrome
- Age> 65 years
- ECOG performance status> 2
- Absence of written informed consent
- Being unable to comply with protocol procedures
- Be fertile and not willing to use a method of birth control during treatment and
until the end of it
- Hypersensitivity to any drug protocol
- Positive for HIV
- Abnormal liver and renal functions as indicated below, provided the changes, which
would be not due to the disease: Total bilirubin> 1.5 x upper limit of normal (ULN)
institutional and AST and ALT> 2.5 x ULN, and serum creatinine> 2.5 mg / dL
- Altered cardiac function determined by at least 1 of the following:
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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Number of survival months in treated AML patients less or equal to 65 years as a measure of survival time
Outcome Description:
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
Outcome Time Frame:
2 years
Safety Issue:
No
Authority:
Spain: Spanish Ministry of Health
Study ID:
PETHEMA-LMA10
NCT ID:
NCT01296178
Start Date:
December 2010
Completion Date:
December 2014
Related Keywords:
- Acute Myeloblastic Leukemia
- Leukemia
- Leukemia, Myeloid, Acute
- Leukemia, Myeloid
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