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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"
The investigators propose a multicenter prospective study to evaluate the incidence of occult CNS localization and the impact of such localization on clinical outcome.Adult 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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cerebrospinal fluids exams | Diagnostic Test | cerebrospinal fluids will be examined by conventional cytology and flow cytometry |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the incidence of occult CNS localization in adult patients with ALL | 36 months |
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Inclusion criteria.
Exclusion criteria.
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Adult patients affected by acute lymphoblastic leukemia
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Maria Ilaria Del Principe, Prof | Contact | +390620903219 | del.principe@med.uniroma2.it | |
| Maria Ilaria Del Principe | Contact | +390620903219 | del.principe@med.uniroma2.it |
| Name | Affiliation | Role |
|---|---|---|
| Maria Ilaria Del Principe, Prof | University of Rome Tor Vergata | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tor Vergata University | Recruiting | Roma | RM | 00133 | Italy |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 1, 2020 | Mar 17, 2023 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| ID | Term |
|---|---|
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |