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

This study is currently recruiting participants.
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

April 2, 2012
March 20, 2014
September 2012
September 2016   (final data collection date for primary outcome measure)
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).
Prognostic role on overal survival [ Time Frame: At four years from study entry. ] [ Designated as safety issue: No ]
At 24 months of each type of Severe Infection (SI).
Complete list of historical versions of study NCT01570465 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
Prospective Study on Severe Infections on Acute Myeloid Leukemia (AML) Patients
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.

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.

Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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.

  • AML
  • Adult
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.
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.
Intervention: Other: Observation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
237
September 2016
September 2016   (final data collection date for primary outcome measure)

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.
Both
18 Years to 60 Years
No
Contact: Paola FAZI, Dr. +39 0670390521 p.fazi@gimema.it
Contact: Enrico CREA +39 0670390514 e.crea@gimema.it
Italy
 
NCT01570465
AML1411
No
Gruppo Italiano Malattie EMatologiche dell'Adulto
Gruppo Italiano Malattie EMatologiche dell'Adulto
Not Provided
Principal Investigator: Adriano VENDITTI, Pr. Policlinico Tor Vergata di Roma
Gruppo Italiano Malattie EMatologiche dell'Adulto
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP