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

NCT ID: NCT01570465

Last Updated: 2022-10-12

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 144 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-09-11
• Study Completion Date: 2019-05-05

Brief 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, 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.

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

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Observation

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gruppo Italiano Malattie EMatologiche dell'Adulto

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Adriano VENDITTI, Pr.

Role: PRINCIPAL_INVESTIGATOR

Policlinico Tor Vergata di Roma

Locations

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

Civitanova Marche, Ancona, Italy

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

Alessandria, , Italy

Azienda Ospedaliera - Nuovo Ospedale "Torrette"

Ancona, , Italy

UO Ematologia con trapianto- AOU Policlinico Consorziale di Bari

Bari, , Italy

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

Bologna, , Italy

Divisione di Ematologia Ospedale A. Perrino

Brindisi, , Italy

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

Campobasso, , Italy

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

Caserta, , Italy

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

Catania, , Italy

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

Catanzaro, , Italy

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

Cremona, , Italy

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

Ferrara, , Italy

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

Foggia, , Italy

Divisione di Ematologia Ospedale "Santa Maria Goretti"

Latina, , Italy

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

Lecce, , Italy

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

Messina, , Italy

Ospedale Niguarda ' Ca Granda'

Milan, , Italy

UO Centro Trapianti di Midollo - IRCCS Ospedale Maggiore Policlinico

Milan, , Italy

Centro Oncologico Modenese - Dipartimento di Oncoematologia

Modena, , Italy

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

Napoli, , Italy

Ospedale San Gennaro - ASL Napoli 1

Napoli, , Italy

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

Nocera Inferiore, , Italy

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

Orbassano, , Italy

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

Pagani, , Italy

Ospedali Riuniti "Villa Sofia-Cervello"

Palermo, , Italy

Cattedra di Ematologia CTMO Università degli Studi di Parma

Parma, , Italy

Div. di Ematologia di Muraglia - CTMO Ospedale San Salvatore

Pesaro, , Italy

U.O. Ematologia Clinica - Azienda USL di Pescara

Pescara, , Italy

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

Piacenza, , Italy

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

Pisa, , Italy

Ematologia - Ospedale San Carlo

Potenza, , Italy

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

Reggio Calabria, , Italy

Unità Operativa Complessa di Ematologia - Arcispedale S. Maria Nuova

Reggio Emilia, , Italy

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

Roma, , Italy

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

Roma, , Italy

Policlinico di Tor Vergata

Roma, , Italy

Roma Complesso Ospedaliero S. Giovanni Addolorata

Roma, , Italy

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

Roma, , Italy

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

Roma, , Italy

Università Cattolica del Sacro Cuore - Policlinico A. Gemelli

Roma, , Italy

UOC Medicina Trasfusionale e Cellule Staminali Azienda Ospedaliera San Camillo Forlanini

Rome, , Italy

Istituto di Ematologia - IRCCS Ospedale Casa Sollievo della Sofferenza

San Giovanni Rotondo, , Italy

Serv. di Ematologia Ist. di Ematologia ed Endocrinologia

Sassari, , Italy

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

Treviso, , Italy

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

Tricase, , Italy

Clinica Ematologica - Policlinico Universitario

Udine, , Italy

Countries

Italy

Related Links

http://www.gimema.it

GIMEMA Foundation Website

Other Identifiers

AML1411

Identifier Type: -

Identifier Source: org_study_id