NCT05750706

Brief Summary

The study aims to evaluate incidence of invasive antifungal infections among patients with acute lymphoblastic leukemia Ph negative during the first weeks of treatment

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2022

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

June 1, 2022

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

February 20, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 2, 2023

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2026

Completed
Last Updated

May 6, 2026

Status Verified

March 1, 2026

Enrollment Period

3.8 years

First QC Date

February 20, 2023

Last Update Submit

April 30, 2026

Conditions

Acute Lymphoblastic Leukemia, AdultInvasive Fungal Infections

Outcome Measures

Primary Outcomes (1)

  • Incidence of invasive fungal infections

    Incidence of invasive fungal infections during first week of chemotherapy

    18 months

Secondary Outcomes (1)

  • Mortality rate

    30 months

Study Arms (2)

Patients without invasive fungal infection

Acute lymphoblastic leukemia, no invasive fungal infection

Patients with invasive fungal infection

Acute lymphoblastic leukemia, invasive fungal infection

Other: observation of invasive fungal infections

Interventions

observation of invasive fungal infectionsOTHER

observation of invasive fungal infections during chemotherapy

Patients with invasive fungal infection

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients with B or T acute lymphoblastic leukemia Ph negative

You may qualify if:

  • diagnosis of acute lymphoblastic leukemia Ph negative
  • age more than 18 yo

You may not qualify if:

  • diagnosis of acute lymphoblastic leukemia Ph positive
  • acute lymphoblastic leukemia relapsed/refractory
  • lymphoblastic lymphoma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondazione Policlinico Universitario A. Gemelli IRCCS

Rome, 00168, Italy

Location

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-LymphomaInvasive Fungal Infections

Condition Hierarchy (Ancestors)

Leukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesMycosesBacterial Infections and MycosesInfections

Study Officials

  • Marianna Criscuolo

    Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
12 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 20, 2023

First Posted

March 2, 2023

Study Start

June 1, 2022

Primary Completion

March 31, 2026

Study Completion

March 31, 2026

Last Updated

May 6, 2026

Record last verified: 2026-03

Locations

IT(1)