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Acute Myeloid LeukemiaNCT05541224

A Retrospective Epidemiologic Registry to Gain Insight Into the Characteristics and Prognosis of AML Patients According to the Routinely Used Genetic and Biologic Markers

An observational study of Acute Myeloid Leukemia, run by PETHEMA Foundation at 22 sites in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a retrospective, translational, epidemiologic, multicenter, non-interventional study (No EPA study) to provide insights into disease epidemiology, disease biology, treatment regimens, and clinical outcomes of patients with acute myeloblastic leukemia (AML) in routine clinical practice according to their… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Acute Myeloid Leukemia
How many people
6,917 participants
Where
22 sitesSpain
Study dates
1 Nov 2019to 1 Oct 2020
Phase
Observational
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Adult patients diagnosed with AML (new diagnosis or relapsed/refractory disease). These patients must meet all the inclusion criteria and none of the exclusion criteria specified.

Who may be able to join

  • All adult patients with AML (excluding APL) according to the WHO criteria (2008), regardless of the treatment administered by their treating physician.
  • AML at diagnosis and at relapse or refractoriness.
  • Patients from institutions participating in the ongoing PETHEMA AML registry.
  • Patients with information about the molecular screening including FLT3 with or without NPM1 mutations (including positive/negative or not performed).
  • Ability to give informed consent before the study initiation. Death patients and patients who are no longer contactable or lost to follow-up will be excluded from consent requirement.

Who cannot join

  • Pediatric patients.
  • Acute promyelocytic leukemia.

Trial locations and contacts

22 sites in 1 country.

22 sites in 1 country

Spain22 sites

  • Hospital General Universitario de Albacete

    Albacete

  • Hospital General Universitario de Alicante

    Alicante

  • Hospital Germans Trias i Pujol-ICO

    Badalona

  • Hospital Universitario de Burgos

    Burgos

  • Hospital San Pedro de Alcántara

    Cáceres

  • Hospital General Universitario de Castellón

    Castellon

  • Hospital Universitario Reina Sofía

    Córdoba

  • Hospital Universitario de Gran Canaria Doctor Negrín

    Las Palmas de Gran Canaria

  • Hospital Universitario de León

    León

  • Hospital Universitario Lucus Augusti

    Lugo

  • Hospital Clínico San Carlos

    Madrid

  • Hospital Univeristario Ramón y Cajal

    Madrid

  • Hospital Universitario 12 de Octubre

    Madrid

  • Hospital Universitario Fundación Jiménez Díaz

    Madrid

  • Hospital General Universitario Morales Meseguer

    Murcia

  • Hospital Universitario Central Asturias

    Oviedo

  • Clínica Universitaria de Navarra

    Pamplona

  • Hospital Universitario de Salamanca

    Salamanca

  • Hospital Universitario Virgen del Rocío

    Seville

  • Hospital Clínico Universitario de Valencia

    Valencia

  • Hospital Universitari I Politécnic La Fe

    Valencia

  • Hospital Universitario Doctor Peset

    Valencia

Other trials in Spain

About this study

This is a retrospective, translational, epidemiologic, multicenter, non-interventional study (No EPA study) to provide insights into disease epidemiology, disease biology, treatment regimens, and clinical outcomes of patients with acute myeloblastic leukemia (AML) in routine clinical practice according to their molecular markers.

The primary objective of the study is to describe the use of the main molecular markers (FLT3 and NPM1) in the real-life according of the type of AML, treating institution, patients' characteristics, and disease status.

Read the detailed description

This is a retrospective, translational, epidemiologic, multicenter, non-interventional study (No EPA study) to provide insights into disease epidemiology, disease biology, treatment regimens, and clinical outcomes of patients with AML in routine clinical practice according to their molecular markers.

Once it has been confirmed that all selection criteria for the study have been met and informed consent has been obtained, the subject will be considered enrolled in the study and the investigator can proceed to collect data from their medical record by completing a case report (CRF).

The study contemplates the retrospective collection of data from disease diagnosis to the start of the study. Only data obtained before the start of the study will be collected in order to ensure they are retrospective in nature.

The study will be conducted following the requirements contained in the Declaration of Helsinki (Fortaleza, Brazil 2013) and in accordance with the current Spanish legislation with regard to conducting observational studies (Ministerial Order SAS/3470/2009).

The primary objective of the study is to describe the use of the main molecular markers (FLT3 and NPM1) in the real-life according of the type of AML, treating institution, patients' characteristics, and disease status.

This project will be conducted in the Spanish PETHEMA cooperative group, constituted by 60 institutions and seven main central laboratories with extensive technological capacity. All patients will be included in the ongoing PETHEMA epidemiologic registry of AML with the purpose to collect a large number, additional and non-pre-existent clinical data, including first-line and salvage treatment schedules and outcomes of each patient.

For this study the PETHEMA AML registry will be enlarged seeking for new cases not previously reported. The data base information will be updated emphasizing for the capture of new data on molecular screening tests performed on a routine basis (FLT3, NPM1, and others). For these purpose, information will be systematically requested from the main PETHEMA laboratories. Therapies and clinical outcome data will be retrospectively collected. This is a one-step study without intervention, in which all analyses will be performed at the end of the database completion.

Keywords
De novo Acute Myeloid Leukemia, Relapsed/refractory Acute Myeloid Leukemia
Medical subject headings
Leukemia, Myeloid, Acute

What is being measured

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

  1. Percentage of patients with molecular alterations (FLT3 and NPM1 mutations).

    Percentage of each of the standard screening panel molecular alterations studied in the AML patients (FLT3 and NPM1) by AML type, by center, by patient's characteristics and the disease status.

    Measured: Baseline

Secondary outcomes (4)

  1. Overall response rate.

    Percentage of patients achieving response in each group of the baseline alterations studied in the AML patients (FLT3 and NPM1) .

    Measured: Throughout the study period. Approximately 1 year

  2. Description of initial and later treatments in each baseline alterations studied (FLT3 and NPM1) in each AML type.

    Frequency of initial and later type of treatments in each baseline alterations studied (FLT3 and NPM1) in each AML type.

    Measured: Baseline and throughout the study period. Approximately 1 year

  3. Molecular response rate.

    Percentage of patients achieving molecular response in each group of the baseline alterations studied in the AML patients (FLT3 and NPM1) .

    Measured: Throughout the study period. Approximately 1 year

  4. Description of biology of disease at relapse or refractoriness by molecular characteristics.

    Percentage of AML type at relapse or refractoriness in each baseline alterations studied (FLT3 and NPM1).

    Measured: Baseline and throughout the study period. Approximately 1 year

Timeline

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

  1. First posted15 Sep 2022
  2. Study start1 Nov 2019
  3. Primary completion1 Oct 2020
  4. Study completion1 Oct 2020

Resources

More details

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

Study design
Study type
Observational
Observational model
Case only
Time perspective
Retrospective
Enrolment
6,917 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05541224
Sponsor's protocol ID
REAL-MOL
Status last verified
Sep 2022
First submitted
12 Sep 2022
Last updated
15 Sep 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Schlenk RF, Dohner K, Krauter J, Frohling S, Corbacioglu A, Bullinger L, Habdank M, Spath D, Morgan M, Benner A, Schlegelberger B, Heil G, Ganser A, Dohner H; German-Austrian Acute Myeloid Leukemia Study Group. Mutations and treatment outcome in cytogenetically normal acute myeloid leukemia. N Engl J Med. 2008 May 1;358(18):1909-18. doi: 10.1056/NEJMoa074306.

    PubMed 18450602

  • Thiede C, Steudel C, Mohr B, Schaich M, Schakel U, Platzbecker U, Wermke M, Bornhauser M, Ritter M, Neubauer A, Ehninger G, Illmer T. Analysis of FLT3-activating mutations in 979 patients with acute myelogenous leukemia: association with FAB subtypes and identification of subgroups with poor prognosis. Blood. 2002 Jun 15;99(12):4326-35. doi: 10.1182/blood.v99.12.4326.

    PubMed 12036858

  • Frohling S, Schlenk RF, Breitruck J, Benner A, Kreitmeier S, Tobis K, Dohner H, Dohner K; AML Study Group Ulm. Acute myeloid leukemia. Prognostic significance of activating FLT3 mutations in younger adults (16 to 60 years) with acute myeloid leukemia and normal cytogenetics: a study of the AML Study Group Ulm. Blood. 2002 Dec 15;100(13):4372-80. doi: 10.1182/blood-2002-05-1440. Epub 2002 Aug 8.

    PubMed 12393388

  • Kottaridis PD, Gale RE, Frew ME, Harrison G, Langabeer SE, Belton AA, Walker H, Wheatley K, Bowen DT, Burnett AK, Goldstone AH, Linch DC. The presence of a FLT3 internal tandem duplication in patients with acute myeloid leukemia (AML) adds important prognostic information to cytogenetic risk group and response to the first cycle of chemotherapy: analysis of 854 patients from the United Kingdom Medical Research Council AML 10 and 12 trials. Blood. 2001 Sep 15;98(6):1752-9. doi: 10.1182/blood.v98.6.1752.

    PubMed 11535508

  • Gale RE, Hills R, Kottaridis PD, Srirangan S, Wheatley K, Burnett AK, Linch DC. No evidence that FLT3 status should be considered as an indicator for transplantation in acute myeloid leukemia (AML): an analysis of 1135 patients, excluding acute promyelocytic leukemia, from the UK MRC AML10 and 12 trials. Blood. 2005 Nov 15;106(10):3658-65. doi: 10.1182/blood-2005-03-1323. Epub 2005 Aug 2.

    PubMed 16076872

  • Rombouts WJ, Blokland I, Lowenberg B, Ploemacher RE. Biological characteristics and prognosis of adult acute myeloid leukemia with internal tandem duplications in the Flt3 gene. Leukemia. 2000 Apr;14(4):675-83. doi: 10.1038/sj.leu.2401731.

    PubMed 10764154

  • Yokota S, Kiyoi H, Nakao M, Iwai T, Misawa S, Okuda T, Sonoda Y, Abe T, Kahsima K, Matsuo Y, Naoe T. Internal tandem duplication of the FLT3 gene is preferentially seen in acute myeloid leukemia and myelodysplastic syndrome among various hematological malignancies. A study on a large series of patients and cell lines. Leukemia. 1997 Oct;11(10):1605-9. doi: 10.1038/sj.leu.2400812.

    PubMed 9324277

  • Whitman SP, Archer KJ, Feng L, Baldus C, Becknell B, Carlson BD, Carroll AJ, Mrozek K, Vardiman JW, George SL, Kolitz JE, Larson RA, Bloomfield CD, Caligiuri MA. Absence of the wild-type allele predicts poor prognosis in adult de novo acute myeloid leukemia with normal cytogenetics and the internal tandem duplication of FLT3: a cancer and leukemia group B study. Cancer Res. 2001 Oct 1;61(19):7233-9.

    PubMed 11585760

  • Dohner K, Schlenk RF, Habdank M, Scholl C, Rucker FG, Corbacioglu A, Bullinger L, Frohling S, Dohner H. Mutant nucleophosmin (NPM1) predicts favorable prognosis in younger adults with acute myeloid leukemia and normal cytogenetics: interaction with other gene mutations. Blood. 2005 Dec 1;106(12):3740-6. doi: 10.1182/blood-2005-05-2164. Epub 2005 Jul 28.

    PubMed 16051734

  • Verhaak RG, Goudswaard CS, van Putten W, Bijl MA, Sanders MA, Hugens W, Uitterlinden AG, Erpelinck CA, Delwel R, Lowenberg B, Valk PJ. Mutations in nucleophosmin (NPM1) in acute myeloid leukemia (AML): association with other gene abnormalities and previously established gene expression signatures and their favorable prognostic significance. Blood. 2005 Dec 1;106(12):3747-54. doi: 10.1182/blood-2005-05-2168. Epub 2005 Aug 18.

    PubMed 16109776

  • Suzuki T, Kiyoi H, Ozeki K, Tomita A, Yamaji S, Suzuki R, Kodera Y, Miyawaki S, Asou N, Kuriyama K, Yagasaki F, Shimazaki C, Akiyama H, Nishimura M, Motoji T, Shinagawa K, Takeshita A, Ueda R, Kinoshita T, Emi N, Naoe T. Clinical characteristics and prognostic implications of NPM1 mutations in acute myeloid leukemia. Blood. 2005 Oct 15;106(8):2854-61. doi: 10.1182/blood-2005-04-1733. Epub 2005 Jun 30.

    PubMed 15994285

  • Dohner H, Estey E, Grimwade D, Amadori S, Appelbaum FR, Buchner T, Dombret H, Ebert BL, Fenaux P, Larson RA, Levine RL, Lo-Coco F, Naoe T, Niederwieser D, Ossenkoppele GJ, Sanz M, Sierra J, Tallman MS, Tien HF, Wei AH, Lowenberg B, Bloomfield CD. Diagnosis and management of AML in adults: 2017 ELN recommendations from an international expert panel. Blood. 2017 Jan 26;129(4):424-447. doi: 10.1182/blood-2016-08-733196. Epub 2016 Nov 28.

    PubMed 27895058

  • Hellmann F, Verdi M, Schlemper BR Jr, Caponi S. 50th anniversary of the Declaration of Helsinki: the double standard was introduced. Arch Med Res. 2014 Oct;45(7):600-1. doi: 10.1016/j.arcmed.2014.10.005. Epub 2014 Oct 31.

    PubMed 25450586

Questions about this trial

What is this clinical trial studying?

An observational study of Acute Myeloid Leukemia, run by PETHEMA Foundation at 22 sites 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 5 inclusion and 2 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: finished, as of the sponsor's last update on 15 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 22 sites 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of patients with molecular alterations (FLT3 and NPM1 mutations). (time frame: Baseline). 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 NCT05541224, which also lists 13 linked publications.

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 15 Sep 2022.

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