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

AML Clinical Trial

— AML1411  

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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01570465
• Other study ID #: AML1411
• Status: Terminated
• Start date: September 11, 2012
• Est. completion date: May 5, 2019

Study information

• Verified date: October 2022
• Source: Gruppo Italiano Malattie EMatologiche dell'Adulto
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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, 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:

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 144
• Est. completion date: May 5, 2019
• Est. primary completion date: May 28, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Adult
• AML
• Leukemia, Myeloid, Acute

Intervention

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.

Locations

Country	Name	City	State
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	U.O. di Medicina Interna - ASUR Marche 8 - Ospedale Civile	Civitanova Marche	Ancona
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'	Milano
Italy	UO Centro Trapianti di Midollo - IRCCS Ospedale Maggiore Policlinico	Milano
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

Sponsors (1)

Lead Sponsor	Collaborator
Gruppo Italiano Malattie EMatologiche dell'Adulto

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prognostic role on overall survival	At 24 months of each type of Severe Infection (SI).	At four years from study entry.
Secondary	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	At four years from study entry
Secondary	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.	At four years from study entry.
Secondary	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;	At 4 years from study entry
Secondary	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;	At 4 years from study entry.
Secondary	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);	At 4 years from study entry
Secondary	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;	At 4 years from study entry
Secondary	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;	At 4 years from study entry
Secondary	Impact of SI in the quality of life.	To evaluate the impact of SI in the quality of life.	At 4 years from study entry

External Links

•   GIMEMA Foundation Website