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

Acute Lymphoblastic Leukemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03803670
• Other study ID #: RS176/17
• Status: Completed
• Start date: January 1, 2007
• Est. completion date: January 10, 2019

Study information

• Verified date: January 2019
• Source: University of Rome Tor Vergata
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 241
• Est. completion date: January 10, 2019
• Est. primary completion date: January 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• ALL at onset

• Age >18 years

Exclusion Criteria:

• ALL relapsed or refractory

• Age <18 years

Related Conditions & MeSH terms

• Acute Lymphoblastic Leukemia
• Central Nervous System Diseases
• Leukemia
• Leukemia, Lymphoid
• Nervous System Diseases
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Intervention

Diagnostic Test:
• evaluation of cerebrospinal fluid of ALL
We evaluated cerebrospinal fluids of patients with ALL by conventional cytology and by flow cytometry

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Rome Tor Vergata

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	impact of occult CNS disease	relapse rate	10 years
Primary	impact of occult CNS disease on outcome	overall survival	10 years