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

NCT01296178 | Unknown DMC

• 1 other identifier: PETHEMA-LMA10
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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

Conditions

Acute Myeloblastic Leukemia

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (2)

• Response rates

  2 years

• Determinate the minimal residual disease

  2 years

Interventions

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

Eligibility Criteria

• Age: Up to 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• PETHEMA Foundation: lead

Study Sites (1)

Hospital La Fe

Valencia, Spain

RECRUITING

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

Idarubicin; Cytarabine

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Arabinonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Central Study Contacts

Federico Moscardó, Dr

CONTACT

+34 963862745; fedemoscardo@yahoo.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2011
• First Posted: February 15, 2011
• Study Start: December 1, 2010
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: March 23, 2021

Record last verified: 2021-03

Locations

ES (1)