Infections

All Conditions

Neoplasms

Blood and Lymph Conditions

Symptoms and General Pathology

Rare Diseases

Leukemia

Communicable Diseases

Mycoses

Invasive Fungal Infections

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Candidiasis

Aspergillosis

Neoplasms by Histologic Type

Hematologic Diseases

Bacterial Infections

Bacterial Infections and Mycoses

Myeloid Leukemia

Acute Myeloid Leukemia

Acute Non Lymphoblastic Leukemia

Acute Graft Versus Host Disease

Adult and pediatric patients with newly diagnosed acute myeloid leukemia, both eligible and not eligible for intensive chemotherapy. Since this is a non-interventional study, therapeutic strategies remains related to local guidelines. Will be treated as cases all patients with acute leukemia in first induction developing an Invasive Fungal Infection according to international EORTC criteria for possible/probable/proven infections. Patients who do not develop the infection will be used as a control group.

Massimo Offidani, MD

Mario Delia, MD

Giorgina Specchia

Mario Delia

Nicola Vianelli

Rosa Fanci, MD

Rosa Fanci

Vincenzo Pavone

Annamaria Nosari, MD

Livio Pagano, MD

Morena Caira, MD

Mario Mancinelli, MD

Maria Grazia Garzia

Anna Chierichini

Adriano Venditti

Alessandro Busca

Chiara Cattaneo, MD

Chiara Cattaneo

Giuseppe Rossi

Adriana Vacca

Cristina Gasbarrino

Sergio Storti

Desiree Caselli

Elio Castagnola

Annunziata Manna

De Paolis

Mario Luppi

Luisa Verga

Marco Picardi, MD

Maria Enza Mitra

Cecilia Caramatti

Carlo Castagnola

Rosangela Invernizzi

Franco Aversa

Prassede Salutari

Bruno Martino

Alessandro Bonini

Lorella Melillo

Mareva Giacchino

Anna Candoni

Gianpaolo Nadali

Simone Cesaro

SEIFEM 2010 study is a prospective, multicenter registry designed to identify and analyze risk factors for developing an invasive fungal infection in patients with newly diagnosed Acute Myeloid Leukemia, with particular interest on pre-hospital risk factors (i.e. those related to normal activities of daily life, such as occupation, location and type of residence, consume of tobacco, alcohol and others).

SEIFEM 2010:

EPIDEMIOLOGICAL SURVEY ON POSSIBLE PRE-HOSPITAL RISK FACTORS FOR DEVELOPING INVASIVE FUNGAL INFECTIONS IN PATIENTS AFFECTED BY ACUTE MYELOID LEUKEMIA

Background:

In two different multicenter surveys conducted in Italy from 1988-1997 and 1999-2003, (Invasive Fungal Infections) IFIs were found to be a frequent cause of morbidity and mortality in patients treated with conventional chemotherapies, particularly in those suffering from acute myeloid leukemia (AML).

In general, the major factors that have been recognized as influencing the likelihood of invasive fungal infection are the patient's immune status, the degree of any organ damage (e.g., mucositis), and overall microbial exposure (i.e., colonization, environment, and prior infection). Since the 1990s, different risk-stratification strategies have been evaluated in order to identify those patients who may benefit from intensive prophylactic and diagnostic measures. However, despite having similar risk profiles, only a subset of AML patients will develop an IFI. One of the most exciting recent advances in the understanding of the epidemiology of IFIs is the recognition of the complexity of the host and the identification of new host-related risk factors.

Aim of this study is to identify and analyze risk factors for developing an invasive fungal infection in patients with newly diagnosed Acute Myeloid Leukemia, with particular interest on pre-hospital risk factors.

Aims and objective:

* To identify high risk subjects that can take advantage of an antifungal prophylaxis or an early antifungal treatment (preemptive treatment).
* To identify possible fungal infections sources for the period preceding the diagnosis of leukemia, in particular those related to normal activities of daily life (e.g. occupation, location and type of residence, consume of tobacco, alcohol or illicit drugs and others).
* To analyze hospital-related sources of fungal infection, from well known predisposing factors (i.e. duration and severity of neutropenia) to other like central venous catheter, urinary catheter, comorbidities, etc.
* To analyze the impact of both the prophylactic regimen adopted and the antifungal treatment.

Design:

* Prospective, multicenter, observational and clinical-epidemiological study.
* The study is expected to enroll at least 500 patients with newly diagnosed acute myeloid leukemia, those eligible for treatment and those not eligible, within 2 years or until the achievement of a statistically evaluable number of cases.
* SEIFEM 2010 is a noninterventional registry and therefore there will not be any any change physicians' diagnostic and therapeutic choices, that remain related to local guidelines.
* Every patient who accept to take part to the study, will be asked to read and sign an informed consent.
* An apposite form, with a detailed epidemiological section, should be compiled by clinicians for each enrolled patient.
* A complete information page on the study is supplied to each patient enrolled.

Data collection:

In the questionnaire, possible risk factors for invasive fungal infections, prior to the onset of acute leukemia, are evaluated. The module consists of several sections:

* Personal information (age, sex, observation time of the case, AML subtype, performance status at admission), patient data will be anonymous.
* Comorbidities (diabetes, chronic renal failure, COPD, chronic liver disease, previous TBC)
* A section compiled by the patient about possible risk factors related to the daily living habits (location and type of residence, profession, hobbies, pets, personal hygiene, ambiental exposures, consume of tobacco, alcohol or illicit drugs and others)
* A second part of the form will be compiled at the time of evaluation after induction chemotherapy (between 30 and 40 days after chemotherapy) or, for those not suitable for conventional treatment, 30-40 days after diagnosis.

At the time of a diagnosis of fungal infection data on the type of infection, treatment and course of infection will be evaluated.

Eligibility:

Adult and pediatric patients with newly diagnosed acute myeloid leukemia, both eligible and not eligible for intensive chemotherapy. Since this is a noninterventional study, therapeutic strategies remains related to local guidelines. Will be treated as cases all patients with acute leukemia in first induction developing an Invasive Fungal Infection according to international EORTC criteria for possible/probable/proven infections. Patients who do not develop the infection will be used as a control group.

Participating centers:

Forty-three Italian divisions of Hematology will take part to the study, distributed among universities and highly specialized hospitals located throughout the country.

Pre-hospital Risk Factors for Invasive Fungal Infection

SEIFEM 2010: Epidemiological Survey on Possible Pre-Hospital Risk Factors for Developing Invasive Fungal Infections in Patients Affected by Acute Myeloid Leukemia

To identify possible fungal infections sources for the period preceding the diagnosis of leukemia, in particular those related to normal activities of daily life (e.g. occupation, location and type of residence, consume of tobacco, alcohol or illicit drugs and others).

Catholic University of the Sacred Heart

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Immune System Diseases

Acquired Immunodeficiency Syndrome

HIV Infections

Neutropenia

Disease Attributes

Granulocytopenia

Anti-Infective Agents

All Drugs and Chemicals

Amphotericin B

Liposomal amphotericin B

Fluconazole

Clotrimazole

Miconazole

Antifungal Agents

Enzyme Inhibitors

Cytochrome P-450 Enzyme Inhibitors

Hormones

Hormone Antagonists

Amebicides

Antiprotozoal Agents

Antiparasitic Agents

Anti-Bacterial Agents

To compare the safety, tolerance and efficacy of fluconazole and amphotericin B as treatment for biopsy proven fungal infections in major organs, disseminated infection, suspected fungal infection and fungemia in adult neutropenic and non-neutropenic patients without AIDS, AIDS related complex (ARC), or extensive burns. HIV seropositive patients are allowed only if they also have a malignancy.

A Comparison of Fluconazole and Amphotericin B in the Treatment of Fungal Infections

Fluconazole Versus Amphotericin B: A Prospective, Randomized, Multicenter Study for Therapy of Fungal Infection

Pfizer

Eye Diseases

Nervous System Diseases

Diseases and Abnormalities at or Before Birth

Retinoblastoma

Brain Neoplasms

Wilms Tumor

Neuroblastoma

Central Nervous System Neoplasms

Nervous System Neoplasms

Brain Diseases

Central Nervous System Diseases

Neuroectodermal Tumors, Primitive, Peripheral

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Neuroepithelial

Neoplasms, Germ Cell and Embryonal

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Kidney Neoplasms

Urologic Neoplasms

Urogenital Neoplasms

Syndrome

Neoplastic Syndromes, Hereditary

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Kidney Diseases

Urologic Diseases

Male Urogenital Diseases

Genetic Diseases, Inborn

Retinal Neoplasms

Eye Neoplasms

Eye Diseases, Hereditary

Retinal Diseases

Wilms' Tumor

Neuroepithelioma

Itraconazole

Hydroxyitraconazole

Cytochrome P-450 CYP3A Inhibitors

2.5 mg/kg twice daily for the first two days --\> once daily

itraconazole

KiWoong Sung, MD, PhD

The purpose of this study is to investigate whether the prophylactic use of itraconazole is a better option than empirical use of itraconazole in the management (prevention and treatment) of fungal infection associated with high-dose chemotherapy and autologous hematopoietic stem cell transplantation in children with high-risk solid tumor.

With the advance of chemoradiotherapy, survival of patients, especially children, with malignant disease has improved. However, prognosis is still poor with conventional chemotherapy if patients have an advanced or high-risk tumor at diagnosis. Outcome in advanced or high-risk pediatric solid tumor such as advanced neuroblastoma, high-risk brain tumor, or recurrent pediatric solid tumor is still not satisfactory with conventional chemotherapy. In this context, investigators have explored the possible efficacy of high-dose chemotherapy (HDCT) and autologous stem cell transplantation (ASCT) in patients with high-risk or relapsed pediatric solid tumor. Efficacy of HDCT and ASCT has been well demonstrated in high-risk neuroblastoma, high-risk brain tumor, and recurrent pediatric solid tumors. Therefore, now, HSCT and ASCT is the most important treatment modality in the treatment of a variety of pediatric solid tumors poorly responding to conventional chemotherapy.

However, although HDCT and ASCT has improved the survival of patients with high-risk tumor, a variety of clinical issues associated with HDCT and ASCT are present causing significant morbidity and even mortality. The most frequent cause of morbidity associated with HDCT and ASCT is infection. Once high-dose myeloablative chemotherapeutic agents are administered, most hematopoietic cells in bone marrow die and prolonged marrow aplasia is unavoidable even after autologous hematopoietic stem cells infusion because it takes time for infused stem cells to reconstitute sufficient hematopoietic function. In addition, high-dose chemotherapy results in severe gastrointestinal mucosal damage which facilitates bacterial and/or fungal infection via damaged mucosal barrier. Therefore, infection is a major cause of morbidity and mortality associated with HDCT and ASCT. Common pathogens associated with infection during HDCT and ASCT are bacteria and fungi.

To reduce the chance of infection and therefore, to reduce the morbidity and mortality from severe infection, various prophylactic antibiotics including antibacterial, antifungal, and antiviral agents have been used according to standard guideline in allogeneic stem cell transplantation. However, in autologous transplantation for solid tumor in which hematologic recovery is rapid and immune suppression is less severe than allogeneic transplantation, there is no standard guideline for the use of prophylactic antibiotics whereas infection is the most important cause of morbidity. Standard guideline for the use of prophylactic antifungal agent is also not available. While some institutes use anti-fungal agent prophylactically, others use antifungal agent empirically only when neutropenic fever persist despite of empirical use of antibacterial agents.

HDCT in pediatric solid tumor is generally more intensive, and therefore, usually cause more severe mucositis than that in adult tumor. Severe mucositis facilitates fungal infection via damaged mucosal barrier (mainly by Candida species). Therefore, use of prophylactic anti-fungal agent may reduce the morbidity and mortality associated with HDCT and ASCT in pediatric solid tumor. However, there is no randomized clinical study to evaluate the efficacy of prophylactic use of anti-fungal agent to date.

Itraconazole is one of newly developed antifungal agents and many physicians started to use itraconazole as first-line antifungal agent in the management of neutropenic fever in immunocompromised patients. However, the efficacy of prophylactic itraconazole has not been established in children with solid tumor, especially who receive HDCT and ASCT.

In this context, we are going to evaluate the efficacy of prophylactic use of itraconazole in children with high-risk solid tumors during HDCT and ASCT. "Prophylactic" group will be treated with itraconazole once ANC fall below 500/uL regardless of infection and "Empirical" group will be treated with itraconazole only when high fever persists despite of treatment with first-line anti-bacterial agents.

Efficacy of Prophylactic Itraconazole in High-Dose Chemotherapy and Autologous Hematopoietic Stem Cell Transplantation

Clinical Study to Evaluate the Efficacy of Prophylactic Itraconazole in High-Dose Chemotherapy and Autologous Hematopoietic Stem Cell Transplantation for Pediatric Solid Tumors

Samsung Medical Center

Ki Woong Sung

Hematologic Neoplasms

Participants will be considered high risk if they are undergoing high dose chemotherapy for leukemia. This includes, but is not limited to participants with acute myelogenous leukemia, acute lymphoblastic leukemia, or myelodysplastic syndrome. Participants are also considered to be at high risk for IFI if they have undergone allogeneic hematopoietic stem-cell transplantation.

Health-care interventions will be recorded; no additional procedures outside the standard of care will be required.

Standard Care

Medical Director

This will be a retrospective study that includes retrospective chart reviews at major institutions across Canada. The intent of the study is to generate both regional and national incidence data for non-Candida invasive fungal infections (IFI) in high risk participants. The study will include participants receiving stem cell transplant and high dose chemotherapy treatment for leukemia.

Assessment of the Fungal Infection Incidence Across Canada for High Risk Participants With Hematological Disease (P07501)

Temporal Realistic Assessment of the Fungal Infection Incidence Across Canada for High Risk Subjects With Hematological Disease (TRAFIC)

Data were extracted from participant hospital records from the time of initiating chemotherapy or conditioning regimen for their stem cell transplant (index date) until one year post-index date, in order to determine the percentage of high risk participants with non-Candida invasive fungal infections.

Data were extracted from participant hospital records from the time of initiating chemotherapy or conditioning regimen for their stem cell transplant (index date) until one year post-index date, in order to determine the percentage of participants with a specific fungal pathogen.

Data were to be extracted from participant hospital records from 5-9 centers across Canada starting from the time of initiating chemotherapy or conditioning regimen for their stem cell transplant (index date) until one year post-index date, in order to determine the percentage of high risk participants with non-Candida invasive fungal infections.

McGill University Health Centre/Research Institute of the McGill University Health Centre

Merck Sharp & Dohme LLC

Adverse Events were not collected during this study.

Participants were considered high risk for IFI if they were undergoing high dose chemotherapy for leukemia. This includes, but is not limited to participants with acute myelogenous leukemia, acute lymphoblastic leukemia, or myelodysplastic syndrome. Participants were also considered to be at high risk for IFI if they had undergone allogeneic hematopoietic stem cell transplantation.

Participants at High Risk for IFI

Participants were considered high risk for IFI if they were undergoing high dose chemotherapy for leukemia. This includes, but is not limited to participants with acute myelogenous leukemia, acute lymphoblastic leukemia, or myelodysplastic syndrome. Participants were also considered to be at high risk for IFI if they had undergone allogeneic hematopoietic stem-cell transplantation.

Age, Continuous

Sex: Female, Male

Senior Vice President, Global Clinical Development

All enrolled participants who received stem-cell transplant and high dose chemotherapy for leukemia.

Percentage of Participants With Non-Candida Invasive Fungal Infections at a Single Institution

Aspergillus

Fusarium

Penicillium

Missing

All enrolled participants who received stem cell transplant and high dose chemotherapy for leukemia.

Percentage of Participants With a Specific Fungal Pathogen at a Single Institution

Whereas enrollment at 5-9 centers in Canada was planned, this was not accomplished, as data were only collected from a single institution in Canada.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Pre-hospital Risk Factors for Invasive Fungal Infection	NCT01315925	Acute Myeloid L... Aspergillosis Candidiasis Mycoses		-	Catholic University of the Sacred Heart
A Comparison of Fluconazole and Amphotericin B in the Treatment of Fungal Infections	NCT00002277	Mycoses HIV Infections	Fluconazole Amphotericin B	13 Years -	NIH AIDS Clinical Trials Information Service
Efficacy of Prophylactic Itraconazole in High-Dose Chemotherapy and Autologous Hematopoietic Stem Cell Transplantation	NCT00336531	Neuroblastoma Brain Tumor Retinoblastoma Wilms Tumor Mycoses	itraconazole	- 15 Years	Samsung Medical Center
Assessment of the Fungal Infection Incidence Across Canada for High Risk Participants With Hematological Disease (P07501)	NCT01254318	Mycoses Leukemia	Standard Care	-	Merck Sharp & Dohme LLC
Pre-hospital Risk Factors for Invasive Fungal Infection	NCT01315925	Acute Myeloid L... Aspergillosis Candidiasis Mycoses		-	Catholic University of the Sacred Heart
Ph II of Non-myeloablative Allogeneic Transplantation Using TLI & ATG In Patients w/ Cutaneous T Cell Lymphoma	NCT00896493	Mycoses Sezary Syndrome Lymphoma, T-Cel... Bone Marrow Tra... Lymphoma, Non-H... Cutaneous T-cel...	anti-thymocyte ... cyclosporine Lymphoid radiat...	18 Years -	Stanford University

Spots Global Cancer Trial Database for mycoses

Every month we try and update this database with for mycoses cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for mycoses

Every month we try and update this database with for mycoses cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for mycoses cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.