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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03803670
Enrollment
241
Registered
2019-01-14
Start date
2007-01-01
Completion date
2019-01-10
Last updated
2019-01-16

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

Conditions

Acute Lymphoblastic Leukemia

Keywords

acute lymphoblastic leukemia, flow cytometry

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.

Interventions

DIAGNOSTIC_TESTevaluation of cerebrospinal fluid of ALL

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

Sponsors

University of Rome Tor Vergata
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* ALL at onset * Age \>18 years

Exclusion criteria

* ALL relapsed or refractory * Age \<18 years

Design outcomes

Primary

MeasureTime frameDescription
impact of occult CNS disease10 yearsrelapse rate
impact of occult CNS disease on outcome10 yearsoverall survival

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 19, 2026