Ignite Creation Date:
2024-05-06 @ 6:45 PM
Last Modification Date:
2024-10-26 @ 2:54 PM
Study NCT ID:
NCT05772000
Status:
RECRUITING
Last Update Posted:
2023-03-22
First Post:
2023-03-05
Brief Title:
Clinical Significance of Occult Central Nervous System Localization
Sponsor:
University of Rome Tor Vergata
Organization:
University of Rome Tor Vergata
Study Overview
Official Title:
Clinical Significance of Occult Central Nervous System Localization in Adult Patients With Acute Lymphoblastic Leukemia Prospective Multicenter Study
Status:
RECRUITING
Status Verified Date:
2023-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
In acute lymphoblastic leukemia ALL the occult central nervous system CNS involvement appears to be associated with poor prognosis Flow cytometry FCM allows detection of occult CNS localization The current international guidelines do not recommend the use of FCM in the assessment of CNS at onset in adult ALL patients Large-scale prospective studies will help to clarify whether or not patients with occult CNS localization should undergo CNS-directed therapy Understanding this seems particularly important nowadays considering that with the introduction of new drugs monoclonal antibodies next-generation tyrosine kinase inhibitors CAR-T the therapeutic approach of patients with ALS is increasingly chemo-free
Detailed Description:
The investigators propose a multicenter prospective study to evaluate the incidence of occult CNS localization and the impact of such localization on clinical outcomeAdult ALL patients routinely undergo diagnostic lumbar puncture PL cerebrospinal fluids CSF samples will be studied by investigation of conventional cytology CC and FCM at the time of the first and subsequent diagnostic PLs
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None