Observing fungal infections in adults with Ph-negative acute lymphoblastic leukemia during chemotherapy
Prospective Observational Study on the Incidence of Invasive Fungal Infections in Patients With Ph-negative Acute Lymphoblastic Leukemia
This study looks at how often adults with Ph-negative acute lymphoblastic leukemia get serious fungal infections during the early stages of chemotherapy and what factors might influence this.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Brescia) |
| Trial ID | NCT06392581 on ClinicalTrials.gov |
What this trial studies
This observational study aims to document the incidence of invasive fungal infections (IFI) in adult patients with Ph-negative acute lymphoblastic leukemia (ALL) during the early stages of chemotherapy. It will assess various factors such as antifungal prophylaxis, patient age, duration of neutropenia, and type of steroid treatment to understand their relationship with the occurrence of IFI. The study will involve 26 centers and will collect clinical information prospectively over 18 months, followed by an additional 12 months of follow-up. The diagnosis of IFI will be based on established EORTC criteria.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 years or older with Ph-negative acute lymphoblastic leukemia who are starting intensive chemotherapy.
Not a fit: Patients with Ph-positive acute lymphoblastic leukemia or those with relapsing ALL will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the management and prevention of fungal infections in patients undergoing treatment for acute lymphoblastic leukemia.
How similar studies have performed: While there have been studies on fungal infections in cancer patients, this specific observational approach focusing on Ph-negative ALL is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with B Ph-neg or T ALL at onset * Age \> 18 yr at the time of the study * Signature informed consent Exclusion Criteria: * Patients with Ph-pos ALL * Patients with relapsing ALL * Patients with B/T lymphoblastic lymphoma
Where this trial is running
Brescia
- ASST degli Spedali Civili di Brescia — Brescia, Italy (Recruiting)
Study contacts
- Principal investigator: chiara cattaneo, md — Asst Degli Spedali Civili Di Brescia
- Study coordinator: chiara cattaneo, md
- Email: chiara.cattaneo@asst-spedalicivili.it
- Phone: 03039951
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.