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Prospective Study on Severe Infections on Acute Myeloid Leukemia (AML) Patients
AML1411
Prospective Survey on Severe Infections During a Multicenter Study of Risk-adapted, MRD-directed Therapy for Young Adults With Newly Diagnosed Acute Myeloid Leukemia.
1 other identifier
observational
144
1 country
46
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Sep 2012
Longer than P75 for all trials
46 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 2, 2012
CompletedFirst Posted
Study publicly available on registry
April 4, 2012
CompletedStudy Start
First participant enrolled
September 11, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 28, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
May 5, 2019
CompletedOctober 12, 2022
October 1, 2022
4.7 years
April 2, 2012
October 10, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Prognostic role on overall survival
At 24 months of each type of Severe Infection (SI).
At four years from study entry.
Secondary Outcomes (8)
Rate of incidence of SI.
At four years from study entry
The impact of SI on the respect of the step by step time treatment.
At four years from study entry.
Risk factors and prognostic factors of each type of SI.
At 4 years from study entry
Overall and attributable mortality.
At 4 years from study entry.
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
- +3 more secondary outcomes
Study Arms (1)
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.
Interventions
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.
Eligibility Criteria
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.
You may qualify if:
- All patients enrolled in the GIMEMA AML1310 study;
- Signed written informed consent according to ICH/EU/GCP and national local laws.
You may not qualify if:
- Patients not eligible for the GIMEMA AML1310 study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (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
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
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Adriano VENDITTI, Pr.
Policlinico Tor Vergata di Roma
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 2, 2012
First Posted
April 4, 2012
Study Start
September 11, 2012
Primary Completion
May 28, 2017
Study Completion
May 5, 2019
Last Updated
October 12, 2022
Record last verified: 2022-10
Data Sharing
- IPD Sharing
- Will not share