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

Terminated

• Conditions: AML; Adult

• Registration Number: NCT01570465
• Lead Sponsor: Gruppo Italiano Malattie EMatologiche dell'Adulto

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.

Study Timeline

• Study First Submitted: 2012-04-02
• Study First Submitted QC: 2012-04-03
• Study First Posted: 2012-04-04
• Study Start: 2012-09-11
• Primary Completion: 2017-05-28
• Study Completion: 2019-05-05
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-10
• Last Update Posted: 2022-10-12

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 144

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Prognostic role on overall survival	At four years from study entry.	At 24 months of each type of Severe Infection (SI).

Secondary Outcome Measures

Name	Time	Method
Overall and attributable mortality.	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;
Rate of incidence of SI.	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
The impact of SI on the respect of the step by step time treatment.	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.
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	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);
Risk factors and prognostic factors of each type of SI.	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;
Rate of patients receiving each type of antibacterial and antifungal prophylaxis strategies employed during the various antileukemic treatments;	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;
Rate of antibacterial and antifungal administered treatments guided either empirically or by clinical and microbiological evidences;	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;
Impact of SI in the quality of life.	At 4 years from study entry	To evaluate the impact of SI in the quality of life.

Trial Locations

Locations (46)

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

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