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Acute Myeloblastic LeukemiaNCT01296178

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

A study testing IDARUBICINE and ARA-C in people with Acute Myeloblastic Leukemia, run by PETHEMA Foundation at 1 site in Spain.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages Up to 65 years
Conditions the study is for
Acute Myeloblastic Leukemia
What is being tested?
IDARUBICINE and ARA-C
Type of treatment
Injection or infusion
How many people
200 participants
Where
1 siteSpain
Study dates
Dec 2010to Dec 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 65 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

1 site in 1 country.

Federico Moscardó, Dr contact

+34 963862745

fedemoscardo@yahoo.es

Spain1 site, 1 recruiting

  • Hospital La Fe

    Valencia

    Federico Moscardó, Dr, fedemoscardo@yahoo.es

    Recruiting

Other trials in Spain

About this study

Official title: PROTOCOL FOR First Line TREATMENT ADAPTED TO RISK of Acute Myeloblastic Leukemia in Patients LESS THAN OR EQUAL TO 65 YEARS

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

Read the 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
Being tested
IDARUBICINE, ARA-C
Medical subject headings
Leukemia, Myeloid, Acute

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IDARUBICINEDrug

    Administration of chemotherapy induction

    Idarubicin IV Dose of 12 mg/m2/day days 1 to 3

  • ARA-CDrug

    ARA-C 200 mg/m2/day dose continuous infusion of IV days 1 to 7

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 2 years

  2. Patients classification in prognostic groups

    Patients classification in prognostic groups and aplication of individual treatments.

    Measured: 2 years

Secondary outcomes (2)

  1. Response rates

    Correlate the different clinical and biological characteristics with response rates and patient outcomes

    Measured: 2 years

  2. Determinate the minimal residual disease

    Studying the role of minimal residual disease by molecular techniques in anticipation of relapse of AML

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Feb 2011 (estimated)
  2. Study startDec 2010
  3. Primary completionDec 2021 (estimated)
  4. Study completionDec 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01296178
Sponsor's protocol ID
PETHEMA-LMA10
Status last verified
Mar 2021
First submitted
9 Feb 2011
Last updated
23 Mar 2021
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A study testing IDARUBICINE and ARA-C in people with Acute Myeloblastic Leukemia, run by PETHEMA Foundation at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 23 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Federico Moscardó, Dr (+34 963862745, fedemoscardo@yahoo.es), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of survival months in treated AML patients less or equal to 65 years as a measure of survival time (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01296178.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2021; AzTrials last refreshed its copy on 8 Nov 2026.

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