Prospective Study on Severe Infections on Acute Myeloid Leukemia (AML) Patients (AML1411)

October 10, 2022 updated by: Gruppo Italiano Malattie EMatologiche dell'Adulto

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

144

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Alessandria, Italy
        • S.O.C. di Ematologia - Azienda Ospedaliera - SS. Antonio e Biagio e Cesare Arrigo
      • Ancona, Italy
        • Azienda Ospedaliera - Nuovo Ospedale "Torrette"
      • Bari, Italy
        • UO Ematologia con trapianto- AOU Policlinico Consorziale di Bari
      • Bologna, Italy
        • Istituto di Ematologia "Lorenzo e A. Seragnoli" - Università degli Studi di Bologna - Policlinico S. Orsola - Malpighi
      • Brindisi, Italy
        • Divisione di Ematologia Ospedale A. Perrino
      • Campobasso, Italy
        • U.O.C. di Onco-Ematologia - Centro di Ricerca e Formazione ad Alta tecnologia nelle Scienze Biomediche
      • Caserta, Italy
        • U.O.C. di Onco-Ematologia - A.O. S.Anna e S.Sebastiano
      • Catania, Italy
        • Università di Catania - Cattedra di Ematologia - Ospedale "Ferrarotto"
      • Catanzaro, Italy
        • Azienda Ospedaliera Pugliese Ciaccio - Presidio Ospedaliero A.Pugliese - Unità Operativa di Ematologia
      • Cremona, Italy
        • Sezione di Ematologia C.T.M.O. Istituti Ospitalieri
      • Ferrara, Italy
        • Sezione di Ematologia e Fisiopatologia delle Emostasi - Azienda Ospedaliera - Arcispedale S. Anna
      • Foggia, Italy
        • Struttura Complessa di Ematologia Ospedali Riuniti Foggia - Azienda Ospedaliero-Universitaria
      • Latina, Italy
        • Divisione di Ematologia Ospedale "Santa Maria Goretti"
      • Lecce, Italy
        • ASL Le/1 P.O. Vito Fazzi - U.O. di Ematologia ed UTIE
      • Messina, Italy
        • Divisione di Ematologia - Azienda Ospedaliera Ospedali Riuniti "Papardo Piemonte"
      • Milano, Italy
        • UO Centro Trapianti di Midollo - IRCCS Ospedale Maggiore Policlinico
      • Milano, Italy
        • Ospedale Niguarda ' Ca Granda'
      • Modena, Italy
        • Centro Oncologico Modenese - Dipartimento di Oncoematologia
      • Napoli, Italy
        • Azienda Ospedaliera Universitaria - Università degli Studi di Napoli "Federico II" - Facoltà di Medicina e Chirurgia
      • Napoli, Italy
        • Ospedale San Gennaro - ASL Napoli 1
      • Nocera Inferiore, Italy
        • Nocera Inferiore U.O. Medicina Interna Ematologia ed Oncologia P.O. Umberto I
      • Orbassano, Italy
        • Dip. di Scienze Cliniche e Biologiche - Ospedale S. Luigi Gonzaga
      • Pagani, Italy
        • U.O. di Oncoematologia -plesso ospedaliero "A. Tortora" di Pagani
      • Palermo, Italy
        • Ospedali Riuniti "Villa Sofia-Cervello"
      • Parma, Italy
        • Cattedra di Ematologia CTMO Università degli Studi di Parma
      • Pesaro, Italy
        • Div. di Ematologia di Muraglia - CTMO Ospedale San Salvatore
      • Pescara, Italy
        • U.O. Ematologia Clinica - Azienda USL di Pescara
      • Piacenza, Italy
        • Unità Operativa Ematologia e Centro Trapianti - Dipartimento di Oncologia ed Ematologia - AUSL Ospedale di Piacenza
      • Pisa, Italy
        • Università di Pisa - Azienda Ospedaliera Pisana - Dipartimento di Oncologia, dei Trapianti e delle nuove Tecnologie in Medicina - Divisione di Ematologia
      • Potenza, Italy
        • Ematologia - Ospedale San Carlo
      • Reggio Calabria, Italy
        • Dipartimento Emato-Oncologia A.O."Bianchi-Melacrino-Morelli"
      • Reggio Emilia, Italy
        • Unità Operativa Complessa di Ematologia - Arcispedale S. Maria Nuova
      • Roma, Italy
        • U.O.C. Ematologia - Ospedale S.Eugenio
      • Roma, Italy
        • Università Cattolica del Sacro Cuore - Policlinico A. Gemelli
      • Roma, Italy
        • S.C. di Ematologia e Trapianti - I.F.O. Istituto Nazionale Tumori Regina Elena
      • Roma, Italy
        • Padiglione Cesalpino - I piano - Divisione di Ematologia - Ospedale S. Camillo
      • Roma, Italy
        • A.O. "Sant'Andrea"-Università la Sapienza Seconda Facoltà di Medicina e Chirurgia
      • Roma, Italy
        • Policlinico di Tor Vergata
      • Roma, Italy
        • Roma Complesso Ospedaliero S. Giovanni Addolorata
      • Rome, Italy
        • UOC Medicina Trasfusionale e Cellule Staminali Azienda Ospedaliera San Camillo Forlanini
      • San Giovanni Rotondo, Italy
        • Istituto di Ematologia - IRCCS Ospedale Casa Sollievo della Sofferenza
      • Sassari, Italy
        • Serv. di Ematologia Ist. di Ematologia ed Endocrinologia
      • Treviso, Italy
        • Azienda U.L.S.S.9 - U.O. di Ematologia
      • Tricase, Italy
        • U.O. di Ematologia - Azienda Ospedaliera - Pia Fondazione di Culto e di Religione Card. G.Panico
      • Udine, Italy
        • Clinica Ematologica - Policlinico Universitario
    • Ancona
      • Civitanova Marche, Ancona, Italy
        • U.O. di Medicina Interna - ASUR Marche 8 - Ospedale Civile

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Patients not eligible for the GIMEMA AML1310 study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Other: Observation
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prognostic role on overall survival
Time Frame: At four years from study entry.
At 24 months of each type of Severe Infection (SI).
At four years from study entry.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of incidence of SI.
Time Frame: At four years from study entry
Rate of incidence of SI during chemotherapy, transplantation procedures, and follow up of patients enrolled in the GIMEMA study AML1310
At four years from study entry
The impact of SI on the respect of the step by step time treatment.
Time Frame: At four years from study entry.
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.
At four years from study entry.
Risk factors and prognostic factors of each type of SI.
Time Frame: At 4 years from study entry
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;
At 4 years from study entry
Overall and attributable mortality.
Time Frame: At 4 years from study entry.
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;
At 4 years from study entry.
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);
Time Frame: At 4 years from study entry
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);
At 4 years from study entry
Rate of patients receiving each type of antibacterial and antifungal prophylaxis strategies employed during the various antileukemic treatments;
Time Frame: At 4 years from study entry
To evaluate the rate of patients receiving each type of antibacterial and antifungal prophylaxis strategies employed during the various antileukemic treatments;
At 4 years from study entry
Rate of antibacterial and antifungal administered treatments guided either empirically or by clinical and microbiological evidences;
Time Frame: At 4 years from study entry
To estimate the rate of antibacterial and antifungal administered treatments guided either empirically or by clinical and microbiological evidences;
At 4 years from study entry
Impact of SI in the quality of life.
Time Frame: At 4 years from study entry
To evaluate the impact of SI in the quality of life.
At 4 years from study entry

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gruppo Italiano Malattie EMatologiche dell'Adulto

Investigators

  • Principal Investigator: Adriano VENDITTI, Pr., Policlinico Tor Vergata di Roma

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 11, 2012

Primary Completion (Actual)

May 28, 2017

Study Completion (Actual)

May 5, 2019

Study Registration Dates

First Submitted

April 2, 2012

First Submitted That Met QC Criteria

April 3, 2012

First Posted (Estimate)

April 4, 2012

Study Record Updates

Last Update Posted (Actual)

October 12, 2022

Last Update Submitted That Met QC Criteria

October 10, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AML1411

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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