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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Gruppo Italiano Malattie EMatologiche dell'Adulto
Sponsor:
Information provided by (Responsible Party):
Gruppo Italiano Malattie EMatologiche dell'Adulto
ClinicalTrials.gov Identifier:
NCT01570465
First received: April 2, 2012
Last updated: March 20, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention
AML
Adult
Other: Observation

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
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.

Resource links provided by NLM:


Further study details as provided by Gruppo Italiano Malattie EMatologiche dell'Adulto:

Primary Outcome Measures:
  • Prognostic role on overall survival [ Time Frame: At four years from study entry. ] [ Designated as safety issue: No ]
    At 24 months of each type of Severe Infection (SI).


Secondary Outcome Measures:
  • Rate of incidence of SI. [ Time Frame: At four years from study entry ] [ Designated as safety issue: No ]
    Rate of incidence of SI during chemotherapy, transplantation procedures, and follow up of patients enrolled in the GIMEMA study AML1310

  • The impact of SI on the respect of the step by step time treatment. [ Time Frame: At four years from study entry. ] [ Designated as safety issue: No ]
    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.

  • Risk factors and prognostic factors of each type of SI. [ Time Frame: At 4 years from study entry ] [ Designated as safety issue: No ]
    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;

  • Overall and attributable mortality. [ Time Frame: At 4 years from study entry. ] [ Designated as safety issue: No ]
    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;

  • 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 ] [ Designated as safety issue: No ]
    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);

  • 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 ] [ Designated as safety issue: No ]
    To evaluate the rate of patients receiving each type of antibacterial and antifungal prophylaxis strategies employed during the various antileukemic treatments;

  • Rate of antibacterial and antifungal administered treatments guided either empirically or by clinical and microbiological evidences; [ Time Frame: At 4 years from study entry ] [ Designated as safety issue: No ]
    To estimate the rate of antibacterial and antifungal administered treatments guided either empirically or by clinical and microbiological evidences;

  • Impact of SI in the quality of life. [ Time Frame: At 4 years from study entry ] [ Designated as safety issue: No ]
    To evaluate the impact of SI in the quality of life.


Estimated Enrollment: 237
Study Start Date: September 2012
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01570465

Contacts
Contact: Paola FAZI, Dr. +39 0670390521 p.fazi@gimema.it
Contact: Enrico CREA +39 0670390514 e.crea@gimema.it

Locations
Italy
U.O. di Medicina Interna - ASUR Marche 8 - Ospedale Civile Not yet recruiting
Civitanova Marche, Ancona, Italy
Contact: Riccardo Centurioni, Dr.         
Principal Investigator: Riccardo Centurioni, Dr.         
Sub-Investigator: Milena Mirabile, Dr.         
S.O.C. di Ematologia - Azienda Ospedaliera - SS. Antonio e Biagio e Cesare Arrigo Not yet recruiting
Alessandria, Italy
Contact: Lorella De Paoli         
Principal Investigator: Lorella De Paoli, Dr.         
Sub-Investigator: Flavia Salvi, Dr.         
Azienda Ospedaliera - Nuovo Ospedale "Torrette" Recruiting
Ancona, Italy
Contact: Massimo Offidani, Dr.         
Principal Investigator: Massimo Offidani, Dr.         
Sub-Investigator: Debora Capelli, Dr.         
UO Ematologia con trapianto- AOU Policlinico Consorziale di Bari Recruiting
Bari, Italy
Contact: Giogina Specchia, Pr.         
Principal Investigator: Giogina Specchia, Pr.         
Sub-Investigator: Domenico Pastore, Dr.         
Istituto di Ematologia "Lorenzo e A. Seragnoli" - Università degli Studi di Bologna - Policlinico S. Orsola - Malpighi Recruiting
Bologna, Italy
Contact: Giovanni Martinelli, Pr.         
Principal Investigator: Giovanni Martinelli, Pr.         
Sub-Investigator: Cristina Clissa, Dr.         
Divisione di Ematologia Ospedale A. Perrino Not yet recruiting
Brindisi, Italy
Contact: Giovanni Quarta         
Principal Investigator: Giovanni Quarta, Dr.         
Sub-Investigator: Giacomo Loseto, Dr.         
U.O.C. di Onco-Ematologia - Centro di Ricerca e Formazione ad Alta tecnologia nelle Scienze Biomediche Not yet recruiting
Campobasso, Italy
Contact: Sergio Storti, Dr.         
Principal Investigator: Sergio Storti, Dr.         
Sub-Investigator: Cristiana Gasbarrino, Dr.         
U.O.C. di Onco-Ematologia - A.O. S.Anna e S.Sebastiano Not yet recruiting
Caserta, Italy
Contact: Antonio Abbadessa         
Principal Investigator: Antonio Abbadessa, Dr.         
Sub-Investigator: Andrea Camera, Dr.         
Università di Catania - Cattedra di Ematologia - Ospedale "Ferrarotto" Recruiting
Catania, Italy
Contact: Francesco Di Raimondo         
Principal Investigator: Francesco Di Raimondo, Dr.         
Sub-Investigator: Calogero Vetro, Dr.         
Azienda Ospedaliera Pugliese Ciaccio - Presidio Ospedaliero A.Pugliese - Unità Operativa di Ematologia Not yet recruiting
Catanzaro, Italy
Contact: Stefano Molica         
Principal Investigator: Stefano Molica, Dr.         
Sub-Investigator: Maria Grazia Kropp, Dr.         
Sezione di Ematologia C.T.M.O. Istituti Ospitalieri Recruiting
Cremona, Italy
Contact: Francesco Lanza, Dr.         
Principal Investigator: Francesco Lanza, Dr.         
Sub-Investigator: Domenico Pastore, Dr.         
Sezione di Ematologia e Fisiopatologia delle Emostasi - Azienda Ospedaliera - Arcispedale S. Anna Not yet recruiting
Ferrara, Italy
Contact: Antonio Cuneo         
Principal Investigator: Antonio Cuneo, Dr.         
Sub-Investigator: Francesco Cavazzini, Dr.         
Struttura Complessa di Ematologia Ospedali Riuniti Foggia - Azienda Ospedaliero-Universitaria Not yet recruiting
Foggia, Italy
Contact: Silvana Franca, Dr.         
Principal Investigator: Silvana Franca, Dr.         
Sub-Investigator: Celestino Ferrandina, Dr.         
Divisione di Ematologia Ospedale "Santa Maria Goretti" Recruiting
Latina, Italy
Contact: Angelo De Blasio, Dr.         
Principal Investigator: Angelo De Blasio, Dr.         
Sub-Investigator: Antonio Centra, Dr.         
ASL Le/1 P.O. Vito Fazzi - U.O. di Ematologia ed UTIE Recruiting
Lecce, Italy
Contact: Nicola Di Renzo, Dr.         
Principal Investigator: Nicola Di Renzo, Dr.         
Sub-Investigator: Michelina Dargenio, Dr.         
Divisione di Ematologia - Azienda Ospedaliera Ospedali Riuniti "Papardo Piemonte" Recruiting
Messina, Italy
Contact: Maura Brugiatelli, Pr.         
Principal Investigator: Maura Brugiatelli, Pr.         
Sub-Investigator: Piero Terrizzi, Dr.         
UO Centro Trapianti di Midollo - IRCCS Ospedale Maggiore Policlinico Not yet recruiting
Milano, Italy
Contact: Agostino Cortelezzi         
Principal Investigator: Agostino Cortelezzi, Dr.         
Sub-Investigator: Nicola Fracchiolla, Dr.         
Ospedale Niguarda ' Ca Granda' Recruiting
Milano, Italy
Contact: Laura Marbello, Dr.         
Principal Investigator: Laura Marbello, Dr.         
Sub-Investigator: Valentina Mancini, Dr.         
Centro Oncologico Modenese - Dipartimento di Oncoematologia Recruiting
Modena, Italy
Contact: Mario Luppi         
Principal Investigator: Mario Luppi, Dr.         
Sub-Investigator: Monica Morselli, Dr.         
Azienda Ospedaliera Universitaria - Università degli Studi di Napoli "Federico II" - Facoltà di Medicina e Chirurgia Recruiting
Napoli, Italy
Contact: Fabrizio Pane, Pr.         
Principal Investigator: Fabrizio Pane, Pr.         
Sub-Investigator: Giuseppe Cerciello, Dr.         
Ospedale San Gennaro - ASL Napoli 1 Not yet recruiting
Napoli, Italy
Contact: Lucia Mastrullo         
Principal Investigator: Lucia Mastrullo, Dr.         
Sub-Investigator: Maria Rosaria Villa, Dr.         
Nocera Inferiore U.O. Medicina Interna Ematologia ed Oncologia P.O. Umberto I Recruiting
Nocera Inferiore, Italy
Contact: Alfonso Maria D'Arco         
Principal Investigator: Alfonso Maria D'Arco, Pr.         
Sub-Investigator: Catello Califano, Dr.         
Dip. di Scienze Cliniche e Biologiche - Ospedale S. Luigi Gonzaga Recruiting
Orbassano, Italy
Contact: Giuseppe Saglio, Pr.         
Principal Investigator: Giuseppe Saglio, Pr.         
Sub-Investigator: Marco De Gobbi, Dr.         
Ospedali Riuniti "Villa Sofia-Cervello" Not yet recruiting
Palermo, Italy
Contact: Francesco Fabbiano, Pr.         
Principal Investigator: Francesco Fabbiano, Pr.         
Cattedra di Ematologia CTMO Università degli Studi di Parma Recruiting
Parma, Italy
Contact: Cecilia Caramatti, Dr.         
Principal Investigator: Cecilia Caramatti, Dr.         
Sub-Investigator: Elena Rosetti, Dr.         
U.O. Ematologia Clinica - Azienda USL di Pescara Active, not recruiting
Pescara, Italy
Unità Operativa Ematologia e Centro Trapianti - Dipartimento di Oncologia ed Ematologia - AUSL Ospedale di Piacenza Recruiting
Piacenza, Italy
Contact: Daniele Vallisa, Dr.         
Principal Investigator: Daniele Vallisa, Dr.         
Sub-Investigator: Elena Trabacchi, Dr.         
Università di Pisa - Azienda Ospedaliera Pisana - Dipartimento di Oncologia, dei Trapianti e delle nuove Tecnologie in Medicina - Divisione di Ematologia Not yet recruiting
Pisa, Italy
Contact: Mario Petrini         
Principal Investigator: Mario Petrini, Dr.         
Ematologia - Ospedale San Carlo Not yet recruiting
Potenza, Italy
Contact: Michele Pizzuti, Pr.         
Principal Investigator: Michele Pizzuti, Pr.         
Sub-Investigator: Nunzio Filardi, Dr.         
Dipartimento Emato-Oncologia A.O."Bianchi-Melacrino-Morelli" Recruiting
Reggio Calabria, Italy
Contact: Francesco Nobile         
Principal Investigator: Francesco Nobile, Dr.         
Sub-Investigator: Francesca Ronco, Dr.         
Unità Operativa Complessa di Ematologia - Arcispedale S. Maria Nuova Recruiting
Reggio Emilia, Italy
Contact: Francesco Merli, Dr.         
Principal Investigator: Francesco Merli, Dr.         
Sub-Investigator: Annalisa Imovili, Dr.         
Università Cattolica del Sacro Cuore - Policlinico A. Gemelli Not yet recruiting
Roma, Italy
Contact: Simona Sica, Dr.         
Principal Investigator: Simona Sica, Dr.         
Padiglione Cesalpino - I piano - Divisione di Ematologia - Ospedale S. Camillo Recruiting
Roma, Italy
Contact: Leonardo Pacilli         
Principal Investigator: Leonardo Pacilli, Dr.         
Sub-Investigator: Anna Proia, Dr.         
A.O. "Sant'Andrea"-Università la Sapienza Seconda Facoltà di Medicina e Chirurgia Recruiting
Roma, Italy
Contact: Antonella Ferrari, Dr.         
Principal Investigator: Antonella Ferrari, Dr.         
Sub-Investigator: Barbara Veggir, Dr.         
U.O.C. Ematologia - Ospedale S.Eugenio Not yet recruiting
Roma, Italy
Contact: Paolo De Fabritiis, Pr.         
Principal Investigator: Paolo De Fabritiis, Pr.         
S.C. di Ematologia e Trapianti - I.F.O. Istituto Nazionale Tumori Regina Elena Recruiting
Roma, Italy
Contact: Antonio Spadea, Dr.         
Principal Investigator: Antonio Spadea, Dr.         
Sub-Investigator: Mariella D'Andrea, Dr.         
Policlinico di Tor Vergata Not yet recruiting
Roma, Italy
Contact: Adriano VENDITTI, Pr.         
Principal Investigator: Adriano VENDITTI, Pr.         
Sub-Investigator: Corrado GIRMENIA, Dr.         
Roma Complesso Ospedaliero S. Giovanni Addolorata Not yet recruiting
Roma, Italy
Contact: Luciana Annino, Pr.         
Principal Investigator: Luciana Annino, Pr.         
Sub-Investigator: Anna Chierichini, Dr.         
Istituto di Ematologia - IRCCS Ospedale Casa Sollievo della Sofferenza Recruiting
San Giovanni Rotondo, Italy
Contact: Nicola Cascavilla, Pr.         
Principal Investigator: Nicola Cascavilla, Pr.         
Sub-Investigator: Lorella Melillo, Dr.         
Serv. di Ematologia Ist. di Ematologia ed Endocrinologia Recruiting
Sassari, Italy
Contact: Maurizio Longinotti, Pr.         
Principal Investigator: Maurizio Longinotti, Pr.         
Sub-Investigator: Claudio Fozza, Dr.         
Azienda U.L.S.S.9 - U.O. di Ematologia Not yet recruiting
Treviso, Italy
Contact: Filippo Gherlinzoni, Pr.         
Principal Investigator: Filippo Gherlinzoni, Pr.         
Sub-Investigator: Michele Gottardi, Dr.         
U.O. di Ematologia - Azienda Ospedaliera - Pia Fondazione di Culto e di Religione Card. G.Panico Not yet recruiting
Tricase, Italy
Contact: Vincenzo Pavone, Dr.         
Principal Investigator: Vincenzo Pavone, Dr.         
Principal Investigator: Giuseppina Greco, Dr.         
Clinica Ematologica - Policlinico Universitario Recruiting
Udine, Italy
Contact: Anna Candoni, Dr.         
Principal Investigator: Anna Candoni, Dr.         
Sub-Investigator: Erica Simeone, Dr.         
Sponsors and Collaborators
Gruppo Italiano Malattie EMatologiche dell'Adulto
Investigators
Principal Investigator: Adriano VENDITTI, Pr. Policlinico Tor Vergata di Roma
  More Information

Additional Information:
No publications provided

Responsible Party: Gruppo Italiano Malattie EMatologiche dell'Adulto
ClinicalTrials.gov Identifier: NCT01570465     History of Changes
Other Study ID Numbers: AML1411
Study First Received: April 2, 2012
Last Updated: March 20, 2014
Health Authority: Italy: Ethics Committee

Keywords provided by Gruppo Italiano Malattie EMatologiche dell'Adulto:
AML
adult
AML1310 GIMEMA study

Additional relevant MeSH terms:
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Leukemia
Neoplasms by Histologic Type
Neoplasms

ClinicalTrials.gov processed this record on September 15, 2014