Clinical Significance of Occult Central Nervous System Disease In Adult Acute Lymphoblastic Leukemia

Completed

• Conditions: Acute Lymphoblastic Leukemia
• Interventions: Diagnostic Test: evaluation of cerebrospinal fluid of ALL

• Registration Number: NCT03803670
• Lead Sponsor: University of Rome Tor Vergata

Brief Summary

Central nervous system involvement at diagnosis remains an obstacle to a long-term cure of patients affected by acute lymphoblastic leukemia. The investigators have previously reported that flow cytometry (FCM) is better than conventional cytology (CC) in demonstrating the presence of leukemic cells in the patients'(pts) cerebrospinal fluid (CSF), especially in samples with low cell counts. In the framework of the national Campus ALL program aimed at improving the management of adult ALL patients in the context of the GIMEMA protocols, in the present study the investigators retrospectively evaluated the incidence of occult CNS positivity and its impact on outcome in 241 adult pts with newly diagnosed ALL from 13 centers.

Detailed Description

Demographic and of laboratory data of 241 adult patients with ALL were retrospectively recorded. All patients underwent diagnostic lumbar puncture and each cerebrospinal fluid sample was examined by CC and FCM. The investigators identified patients with the only FCM positivity and the investigators correlated this condition with clinical and of laboratory data and with clinical outcome.

Study Timeline

• Study Start: 2007-01-01
• Status Verified: 2019-01
• Primary Completion: 2019-01-01
• Study Completion: 2019-01-10
• Study First Submitted: 2019-01-10
• Study First Submitted QC: 2019-01-10
• Study First Posted: 2019-01-14
• Last Update Submitted: 2019-01-14
• Last Update Posted: 2019-01-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 241

Inclusion Criteria

• ALL at onset
• Age >18 years

Exclusion Criteria

• ALL relapsed or refractory
• Age <18 years

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
acute lymphoblastic leukemia patients	evaluation of cerebrospinal fluid of ALL	We observed within adult patients with ALL three groups of patients: patients without central nervous system (CNS) involvement, patients with manifest CNS involvement and patients with occult CNS involvement.

Primary Outcome Measures

Name	Time	Method
impact of occult CNS disease on outcome	10 years	overall survival
impact of occult CNS disease	10 years	relapse rate