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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05772000

Enrollment

Registered

2023-03-16

Start date

2020-09-08

Completion date

2024-09-08

Last updated

2023-03-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Lymphoblastic Leukemia

Brief 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.

Interventions

DIAGNOSTIC_TESTcerebrospinal fluids exams

cerebrospinal fluids will be examined by conventional cytology and flow cytometry

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
To assess the incidence of occult CNS localization in adult patients with ALL	36 months

Countries

Italy

Contacts

Primary ContactMaria Ilaria Del Principe, Prof

del.principe@med.uniroma2.it+390620903219

Backup ContactMaria Ilaria Del Principe