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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by PETHEMA Foundation
Sponsor:
Information provided by (Responsible Party):
PETHEMA Foundation
ClinicalTrials.gov Identifier:
NCT01296178
First received: February 9, 2011
Last updated: November 19, 2013
Last verified: November 2013
  Purpose

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 Intervention
Acute Myeloblastic Leukemia
Drug: IDARUBICINE
Drug: ARA-C

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: PROTOCOL FOR First Line TREATMENT ADAPTED TO RISK of Acute Myeloblastic Leukemia in Patients LESS THAN OR EQUAL TO 65 YEARS

Resource links provided by NLM:


Further study details as provided by PETHEMA Foundation:

Primary Outcome Measures:
  • Number of survival months in treated AML patients less or equal to 65 years as a measure of survival time [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Patients classification in prognostic groups and aplication of individual treatments.


Secondary Outcome Measures:
  • Response rates [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Correlate the different clinical and biological characteristics with response rates and patient outcomes

  • Determinate the minimal residual disease [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Studying the role of minimal residual disease by molecular techniques in anticipation of relapse of AML


Estimated Enrollment: 200
Study Start Date: December 2010
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Intervention Details:
    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
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
  Eligibility

Ages Eligible for Study:   up to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01296178

Contacts
Contact: Federico Moscardó, Dr +34 963862745 fedemoscardo@yahoo.es

Locations
Spain
Hospital La Fe Recruiting
Valencia, Spain
Contact: Federico Moscardó, Dr       fedemoscardo@yahoo.es   
Sponsors and Collaborators
PETHEMA Foundation
  More Information

No publications provided

Responsible Party: PETHEMA Foundation
ClinicalTrials.gov Identifier: NCT01296178     History of Changes
Other Study ID Numbers: PETHEMA-LMA10
Study First Received: February 9, 2011
Last Updated: November 19, 2013
Health Authority: Spain: Spanish Ministry of Health

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Neoplasms by Histologic Type
Neoplasms
Cytarabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 19, 2014