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

Primary Purpose

Acute Myeloblastic Leukemia

Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
IDARUBICINE
ARA-C
Sponsored by
PETHEMA Foundation
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Myeloblastic Leukemia

Eligibility Criteria

undefined - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital La FeRecruiting

Outcomes

Primary Outcome Measures

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
Patients classification in prognostic groups
Patients classification in prognostic groups and aplication of individual treatments.

Secondary Outcome Measures

Response rates
Correlate the different clinical and biological characteristics with response rates and patient outcomes
Determinate the minimal residual disease
Studying the role of minimal residual disease by molecular techniques in anticipation of relapse of AML

Full Information

First Posted
February 9, 2011
Last Updated
March 22, 2021
Sponsor
PETHEMA Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT01296178
Brief Title
PETHEMA-LMA10: Treatment of Acute Myeloblastic Leukemia (AML) in Patients Less Than or Equal to 65 Years
Official Title
PROTOCOL FOR First Line TREATMENT ADAPTED TO RISK of Acute Myeloblastic Leukemia in Patients LESS THAN OR EQUAL TO 65 YEARS
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
December 2010 (Actual)
Primary Completion Date
December 2021 (Anticipated)
Study Completion Date
December 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
PETHEMA Foundation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myeloblastic Leukemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
IDARUBICINE
Intervention Description
Administration of chemotherapy induction Idarubicin IV Dose of 12 mg/m2/day days 1 to 3
Intervention Type
Drug
Intervention Name(s)
ARA-C
Intervention Description
ARA-C 200 mg/m2/day dose continuous infusion of IV days 1 to 7
Primary Outcome Measure Information:
Title
Number of survival months in treated AML patients less or equal to 65 years as a measure of survival time
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
Time Frame
2 years
Title
Patients classification in prognostic groups
Description
Patients classification in prognostic groups and aplication of individual treatments.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Response rates
Description
Correlate the different clinical and biological characteristics with response rates and patient outcomes
Time Frame
2 years
Title
Determinate the minimal residual disease
Description
Studying the role of minimal residual disease by molecular techniques in anticipation of relapse of AML
Time Frame
2 years

10. Eligibility

Sex
All
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Federico Moscardó, Dr
Phone
+34 963862745
Email
fedemoscardo@yahoo.es
Facility Information:
Facility Name
Hospital La Fe
City
Valencia
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Federico Moscardó, Dr
Email
fedemoscardo@yahoo.es

12. IPD Sharing Statement

Learn more about this trial

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

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