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

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.

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Key information

Conditions

Acute Lymphoblastic Leukemia Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, Lymphoid Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Precursor Cell Lymphoblastic Leukemia-Lymphoma

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

ALL at onset
Age >18 years

Exclusion criteria

ALL relapsed or refractory
Age <18 years

Treatment and study plan

evaluation of cerebrospinal fluid of ALL

Diagnostic Test

We evaluated cerebrospinal fluids of patients with ALL by conventional cytology and by flow cytometry

Primary outcomes

impact of occult CNS disease

Time frame: 10 years

relapse rate
impact of occult CNS disease on outcome

Time frame: 10 years

overall survival

Sponsors and collaborators

Lead sponsor

University of Rome Tor Vergata

Other

Registry information

Official study title

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

Important dates

Study start: 2007
Primary completion: 2019
Study completion: 2019
First posted: Jan 14, 2019
Registry last updated: Jan 16, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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