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AMLAML1411NCT01570465

Prospective Study on Severe Infections on Acute Myeloid Leukemia (AML) Patients

An observational study of AML and Adult, run by Gruppo Italiano Malattie EMatologiche dell'Adulto at 46 sites in Italy.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

All patients receiving induction, consolidation and salvage chemotherapy, and autologous or allogeneic stem cell transplantation according to a strategy defined in the GIMEMA AML1310 protocol will be prospectively monitored for SI (bacteremia, invasive mycoses, other microbiologically documented bacterial infections… Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
AML, Adult
What is being tested?
Observation
How many people
144 participants
Where
46 sitesItaly
Study dates
11 Sep 2012to 5 May 2019
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 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Study population: All patients receiving induction, consolidation and salvage chemotherapy, and autologous or allogeneic stem cell transplantation according to a strategy defined in the GIMEMA AML1310 protocol will be prospectively monitored for SI (bacteremia, invasive mycoses, other microbiologically documented bacterial infections, pneumonia, other invasive tissue infections and viral diseases) during each chemotherapy and transplant and the impact of these infections on survival will be evaluated until 24 months from the diagnosis of AML.

Who may be able to join

  • All patients enrolled in the GIMEMA AML1310 study;
  • Signed written informed consent according to ICH/EU/GCP and national local laws.

Who cannot join

  • Patients not eligible for the GIMEMA AML1310 study.

Trial locations and contacts

46 sites in 1 country.

46 sites in 1 country

Italy46 sites

  • S.O.C. di Ematologia - Azienda Ospedaliera - SS. Antonio e Biagio e Cesare Arrigo

    Alessandria

  • Azienda Ospedaliera - Nuovo Ospedale "Torrette"

    Ancona

  • UO Ematologia con trapianto- AOU Policlinico Consorziale di Bari

    Bari

  • Istituto di Ematologia "Lorenzo e A. Seragnoli" - Università degli Studi di Bologna - Policlinico S. Orsola - Malpighi

    Bologna

  • Divisione di Ematologia Ospedale A. Perrino

    Brindisi

  • U.O.C. di Onco-Ematologia - Centro di Ricerca e Formazione ad Alta tecnologia nelle Scienze Biomediche

    Campobasso

  • U.O.C. di Onco-Ematologia - A.O. S.Anna e S.Sebastiano

    Caserta

  • Università di Catania - Cattedra di Ematologia - Ospedale "Ferrarotto"

    Catania

  • Azienda Ospedaliera Pugliese Ciaccio - Presidio Ospedaliero A.Pugliese - Unità Operativa di Ematologia

    Catanzaro

  • U.O. di Medicina Interna - ASUR Marche 8 - Ospedale Civile

    Civitanova Marche, Ancona

  • Sezione di Ematologia C.T.M.O. Istituti Ospitalieri

    Cremona

  • Sezione di Ematologia e Fisiopatologia delle Emostasi - Azienda Ospedaliera - Arcispedale S. Anna

    Ferrara

  • Struttura Complessa di Ematologia Ospedali Riuniti Foggia - Azienda Ospedaliero-Universitaria

    Foggia

  • Divisione di Ematologia Ospedale "Santa Maria Goretti"

    Latina

  • ASL Le/1 P.O. Vito Fazzi - U.O. di Ematologia ed UTIE

    Lecce

  • Divisione di Ematologia - Azienda Ospedaliera Ospedali Riuniti "Papardo Piemonte"

    Messina

  • Ospedale Niguarda ' Ca Granda'

    Milan

  • UO Centro Trapianti di Midollo - IRCCS Ospedale Maggiore Policlinico

    Milan

  • Centro Oncologico Modenese - Dipartimento di Oncoematologia

    Modena

  • Azienda Ospedaliera Universitaria - Università degli Studi di Napoli "Federico II" - Facoltà di Medicina e Chirurgia

    Naples

  • Ospedale San Gennaro - ASL Napoli 1

    Naples

  • Nocera Inferiore U.O. Medicina Interna Ematologia ed Oncologia P.O. Umberto I

    Nocera Inferiore

  • Dip. di Scienze Cliniche e Biologiche - Ospedale S. Luigi Gonzaga

    Orbassano

  • U.O. di Oncoematologia -plesso ospedaliero "A. Tortora" di Pagani

    Pagani

  • Ospedali Riuniti "Villa Sofia-Cervello"

    Palermo

  • Cattedra di Ematologia CTMO Università degli Studi di Parma

    Parma

  • Div. di Ematologia di Muraglia - CTMO Ospedale San Salvatore

    Pesaro

  • U.O. Ematologia Clinica - Azienda USL di Pescara

    Pescara

  • Unità Operativa Ematologia e Centro Trapianti - Dipartimento di Oncologia ed Ematologia - AUSL Ospedale di Piacenza

    Piacenza

  • Università di Pisa - Azienda Ospedaliera Pisana - Dipartimento di Oncologia, dei Trapianti e delle nuove Tecnologie in Medicina - Divisione di Ematologia

    Pisa

  • Ematologia - Ospedale San Carlo

    Potenza

  • Dipartimento Emato-Oncologia A.O."Bianchi-Melacrino-Morelli"

    Reggio Calabria

  • Unità Operativa Complessa di Ematologia - Arcispedale S. Maria Nuova

    Reggio Emilia

  • A.O. "Sant'Andrea"-Università la Sapienza Seconda Facoltà di Medicina e Chirurgia

    Roma

  • Padiglione Cesalpino - I piano - Divisione di Ematologia - Ospedale S. Camillo

    Roma

  • Policlinico di Tor Vergata

    Roma

  • Roma Complesso Ospedaliero S. Giovanni Addolorata

    Roma

  • S.C. di Ematologia e Trapianti - I.F.O. Istituto Nazionale Tumori Regina Elena

    Roma

  • U.O.C. Ematologia - Ospedale S.Eugenio

    Roma

  • Università Cattolica del Sacro Cuore - Policlinico A. Gemelli

    Roma

  • UOC Medicina Trasfusionale e Cellule Staminali Azienda Ospedaliera San Camillo Forlanini

    Rome

  • Istituto di Ematologia - IRCCS Ospedale Casa Sollievo della Sofferenza

    San Giovanni Rotondo

  • Serv. di Ematologia Ist. di Ematologia ed Endocrinologia

    Sassari

  • Azienda U.L.S.S.9 - U.O. di Ematologia

    Treviso

  • U.O. di Ematologia - Azienda Ospedaliera - Pia Fondazione di Culto e di Religione Card. G.Panico

    Tricase

  • Clinica Ematologica - Policlinico Universitario

    Udine

Other trials in Italy

About this study

Official title: Prospective Survey on Severe Infections During a Multicenter Study of Risk-adapted, MRD-directed Therapy for Young Adults With Newly Diagnosed Acute Myeloid Leukemia.

All patients receiving induction, consolidation and salvage chemotherapy, and autologous or allogeneic stem cell transplantation according to a strategy defined in the GIMEMA AML1310 protocol will be prospectively monitored for SI (bacteremia, invasive mycoses, other microbiologically documented bacterial infections, pneumonia, other invasive tissue infections and viral diseases) during each chemotherapy and transplant and the impact of these infections on survival will be evaluated until 24 months from the diagnosis of AML.

Read the detailed description

Treatment of AML patients during chemotherapy and SCT is frequently complicated by SI which may represent an obstacle to the antileukemic chemotherapy and transplant program. Antimicrobial prophylaxis, diagnostic approaches and antimicrobial therapy should be adapted to the infectious risk of the leukemic population. A crucial problem in the definition of these strategies is represented by the continuous change in the epidemiological patterns of infections as a result of the modification of risk factors in the leukemic population and of the global epidemiology of hospital and community acquired infections. In particular, the emergence of antibiotic resistant pathogens, particularly among gram negative bacteria, represents a serious problem which dramatically impacts on the antibacterial prophylaxis and treatments choices. A continuous epidemiology survey is required in order to better define proper prevention, diagnostic and treatment approaches. A common problem in the infections control in immunocompromised populations is represented by a late epidemiological consciousness. In particular, when new antileukemic strategies are implemented any change in the infectious epidemiology is frequently evidenced later retrospectively, but retrospective studies suffer of several drawbacks in the timely and proper collection of data.

The aim of the AML1310 GIMEMA protocol is to prospectively evaluate in a large population of newly diagnosed young AML patients the effect of a risk-adapted, MDR directed antileukemic strategy which includes chemotherapy and SCT. The objective of the trial is to evaluate the treatment strategy in terms of OS at 24 months and secondary objectives include the response rates and outcome according to clinical and biological characteristics at baseline and along the antileukemic treatment. A further secondary objective of the AML1310 study is the evaluation of the quality of life.

A prospective, longitudinal survey of infectious complications occurring in patients enrolled in the AML1310 study along the entire antileukemic program, as an ancillary observational study, may be a useful tool to evaluate in real-time the epidemiological patterns of infections, their impact on the OS, on the antileukemic treatment schedule, and on the quality of life. First, it may allow to assess whether the various types of SI, in addition to well known clinical and leukemia-related prognostic variables, are actually independent prognostic factors for the long-term outcome of AML patients. Second, the results of this survey may offer precious indications for the timely update of the prophylaxis , diagnosis and treatment strategies of infections in AML patients undergoing a modern antileukemic program. The advances in the treatment of AML resulting from the AML1310 study may be further enriched by the epidemiological consciousness derived by a parallel survey of the infectious complications.

Conditions
AML, Adult
Being tested
Observation
Keywords
AML, adult, AML1310 GIMEMA study

What participants receive

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

  • ObservationOther

    Assess the impact of each type of severe infections (SI) over the 24-month overall survival of young patients with newly diagnosed acute myeloid leukemia along a predefined antileukemic treatment strategy.

Study groups in NCT01570465
Study groupRoleWhat they receive
All patients enrolled in the GIMEMA AML1310 study.* All patients enrolled in the GIMEMA AML1310 study; * Signed written informed consent according to ICH/EU/GCP and national local laws.
Receives: Other: Observation

What is being measured

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

  1. Prognostic role on overall survival

    At 24 months of each type of Severe Infection (SI).

    Measured: At four years from study entry.

Secondary outcomes (8)

  1. Rate of incidence of SI.

    Rate of incidence of SI during chemotherapy, transplantation procedures, and follow up of patients enrolled in the GIMEMA study AML1310

    Measured: At four years from study entry

  2. The impact of SI on the respect of the step by step time treatment.

    To estimate the impact of SI on the respect of the step by step time treatment along the GIMEMA study AML1310. SI will be considered among the causes of delay or discontinuation or change of the leukemia treatment schedule.

    Measured: At four years from study entry.

  3. Risk factors and prognostic factors of each type of SI.

    To estimate the risk factors and prognostic factors of each type of SI according to baseline leukemia risk (low, intermediate and high risk) as defined in the AML1310 protocol;

    Measured: At 4 years from study entry

  4. Overall and attributable mortality.

    To estimate the overall and attributable mortality at 3 months from the onset of the SI. Attributable mortality was defined as progressive organ failure involving the organ(s) in which SI was diagnosed and the absence of other morbid conditions thought, by the attending physician or pathologist, to have contributed to death;

    Measured: At 4 years from study entry.

  5. Rate of the in vitro susceptibility pattern to antimicrobials of bacteria causing SI with particular attention to the emerging resistances in gram negative bacteria (ESBL, KPC MDR);

    To evaluate the rate of the in vitro susceptibility pattern to antimicrobials of bacteria causing SI with particular attention to the emerging resistances in gram negative bacteria (ESBL, KPC MDR);

    Measured: At 4 years from study entry

  6. Rate of patients receiving each type of antibacterial and antifungal prophylaxis strategies employed during the various antileukemic treatments;

    To evaluate the rate of patients receiving each type of antibacterial and antifungal prophylaxis strategies employed during the various antileukemic treatments;

    Measured: At 4 years from study entry

  7. Rate of antibacterial and antifungal administered treatments guided either empirically or by clinical and microbiological evidences;

    To estimate the rate of antibacterial and antifungal administered treatments guided either empirically or by clinical and microbiological evidences;

    Measured: At 4 years from study entry

  8. Impact of SI in the quality of life.

    To evaluate the impact of SI in the quality of life.

    Measured: At 4 years from study entry

Timeline

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

  1. First posted4 Apr 2012 (estimated)
  2. Study start11 Sep 2012
  3. Primary completion28 May 2017
  4. Study completion5 May 2019

Why it stopped: low interest

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
Prospective
Enrolment
144 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01570465
Sponsor's protocol ID
AML1411
Acronym
AML1411
Status last verified
Oct 2022
First submitted
2 Apr 2012
Last updated
12 Oct 2022
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of AML and Adult, run by Gruppo Italiano Malattie EMatologiche dell'Adulto at 46 sites in Italy.

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 2 inclusion and 1 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: stopped early, as of the sponsor's last update on 12 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 46 sites in Italy. 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 was stopped early (reason given: low interest). Results are not available in the source record.

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?

Prognostic role on overall survival (time frame: At four years from study entry.). 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 NCT01570465.

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 12 Oct 2022.

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