NCT03803670

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

Clinical Significance of Occult Central Nervous System Disease In Adult Acute Lymphoblastic Leukemia: A Multicenter, Retrospective Study From The Campus All/Gimema Network

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 241 (actual)
• Sponsor: University of Rome Tor Vergata · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Acute Lymphoblastic Leukemia

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	evaluation of cerebrospinal fluid of ALL	We evaluated cerebrospinal fluids of patients with ALL by conventional cytology and by flow cytometry

Timeline

• Start date: 2007-01-01
• Primary completion: 2019-01-01
• Completion: 2019-01-10
• First posted: 2019-01-14
• Last updated: 2019-01-16