Clinical Significance of Occult Central Nervous System Localization

• Sponsor: University of Rome Tor Vergata (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05772000
• Collaborator: (none)
• Enrollment: 70
• Location: 1
• Anticipated Duration (Months): 48
• Patients Per Site Per Month: 1.5

Study Details

Study Description

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"

Condition or Disease	Intervention/Treatment	Phase
Acute Lymphoblastic Leukemia	Diagnostic Test: cerebrospinal fluids exams

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 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.

Study Design

• Study Type: Observational
• Anticipated Enrollment: 70 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Clinical Significance of Occult Central Nervous System Localization in Adult Patients With Acute Lymphoblastic Leukemia. Prospective, Multicenter Study.
• Actual Study Start Date: Sep 8, 2020
• Anticipated Primary Completion Date: Sep 8, 2023
• Anticipated Study Completion Date: Sep 8, 2024

Outcome Measures

Primary Outcome Measures

1. To assess the incidence of occult CNS localization in adult patients with ALL [36 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion criteria.

• Patients aged more than18 years with diagnosis of ALL at onset undergoing diagnostic-therapeutic PL.

• Signed written informed consent in accordance with ICH/EU/GCP guidelines and national and local laws.

Exclusion criteria.

• Patients <18 years of age

• Diagnosis other than ALL

• Inability to perform PL

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Tor Vergata University	Roma	RM	Italy	00133

Sponsors and Collaborators

• University of Rome Tor Vergata

Investigators

• Principal Investigator: Maria Ilaria Del Principe, Prof, University of Rome Tor Vergata

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Apr 1, 2020

More Information

Publications

None provided.

• Responsible Party: Maria Ilaria Del Principe, Associate Professor, University of Rome Tor Vergata
• ClinicalTrials.gov Identifier: NCT05772000
• Other Study ID Numbers: CampusALL2022
• First Posted: Mar 16, 2023
• Last Update Posted: Mar 22, 2023
• Last Verified: Mar 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid

Study Results

No Results Posted as of Mar 22, 2023