NCT05772000

Clinical Significance of Occult Central Nervous System Localization

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 70 (estimated)
• Sponsor: University of Rome Tor Vergata · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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"

Detailed 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.

Conditions

• Acute Lymphoblastic Leukemia

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	cerebrospinal fluids exams	cerebrospinal fluids will be examined by conventional cytology and flow cytometry

Timeline

• Start date: 2020-09-08
• Primary completion: 2023-09-08
• Completion: 2024-09-08
• First posted: 2023-03-16
• Last updated: 2023-03-22

Locations

1 site across 1 country: Italy