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NCT05772000 Clinical Trial

Clinical Significance of Occult Central Nervous System Localization

Acute Lymphoblastic Leukemia Clinical Trial

Official title:
Clinical Significance of Occult Central Nervous System Localization in Adult Patients With Acute Lymphoblastic Leukemia. Prospective, Multicenter Study.

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05772000
Other study ID # CampusALL2022
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date September 8, 2020
Est. completion date September 8, 2024

Study information
Verified date March 2023
Source University of Rome Tor Vergata
Contact Maria Ilaria Del Principe, Prof
Phone +390620903219
Email del.principe@med.uniroma2.it
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

In acute lymphoblastic leukemia (ALL), the occult central nervous system (CNS) involvement appears to be associated with poor prognosis. Flow cytometry (FCM) allows detection of occult CNS localization. The current international guidelines do not recommend the use of FCM in the assessment of CNS at onset in adult ALL patients. Large-scale prospective studies will help to clarify whether or not patients with occult CNS localization should undergo CNS-directed therapy. Understanding this seems particularly important nowadays considering that with the introduction of new drugs (monoclonal antibodies, next-generation tyrosine kinase inhibitors, CAR-T) the therapeutic approach of patients with ALS is increasingly "chemo-free"

Description:

The investigators propose a multicenter prospective study to evaluate the incidence of occult CNS localization and the impact of such localization on clinical outcome.Adult ALL patients routinely undergo diagnostic lumbar puncture (PL); cerebrospinal fluids (CSF )samples will be studied by investigation of conventional cytology (CC) and FCM at the time of the first and subsequent diagnostic PLs.

Recruitment information / eligibility
Status Recruiting
Enrollment 70
Est. completion date September 8, 2024
Est. primary completion date September 8, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion criteria. - Patients aged more than18 years with diagnosis of ALL at onset undergoing diagnostic-therapeutic PL. - Signed written informed consent in accordance with ICH/EU/GCP guidelines and national and local laws. Exclusion criteria. - Patients <18 years of age - Diagnosis other than ALL - Inability to perform PL

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• cerebrospinal fluids exams
cerebrospinal fluids will be examined by conventional cytology and flow cytometry

Locations
Country Name City State
Italy Tor Vergata University Roma RM

Sponsors (1)
Lead Sponsor Collaborator
University of Rome Tor Vergata

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary To assess the incidence of occult CNS localization in adult patients with ALL 36 months
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