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

• ClinicalTrials.gov Identifier: NCT03803670
• Recruitment Status: Completed
• First Posted: January 14, 2019
• Last Update Posted: January 16, 2019
• Sponsor: University of Rome Tor Vergata
• Information provided by (Responsible Party): Maria Ilaria Del Principe, University of Rome Tor Vergata

Tracking Information

• First Submitted Date: January 10, 2019
• First Posted Date: January 14, 2019
• Last Update Posted Date: January 16, 2019
• Study Start Date: January 1, 2007
• Actual Primary Completion Date: January 1, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: January 14, 2019)

• impact of occult CNS disease [ Time Frame: 10 years ]
  relapse rate
• impact of occult CNS disease on outcome [ Time Frame: 10 years ]
  overall survival

• Original Primary Outcome Measures (submitted: January 10, 2019): incidence of occult CNS disease [ Time Frame: 10 years ]
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Clinical Significance of Occult Central Nervous System Disease In Adult Acute Lymphoblastic Leukemia
• 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
• 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.
• Study Type: Observational
• Study Design: Observational Model: Case-Only; Time Perspective: Retrospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Non-Probability Sample
• Study Population: Adult patients affected by ALL underwent to diagnostic lumbar puncture
• Condition: Acute Lymphoblastic Leukemia

Intervention

Diagnostic Test: evaluation of cerebrospinal fluid of ALL

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

Study Groups/Cohorts

acute lymphoblastic leukemia patients

We observed within adult patients with ALL three groups of patients: patients without central nervous system (CNS) involvement, patients with manifest CNS involvement and patients with occult CNS involvement.

Intervention: Diagnostic Test: evaluation of cerebrospinal fluid of ALL

• Publications *: Del Principe MI, Buzzatti E, Piciocchi A, Forghieri F, Bonifacio M, Lessi F, Imbergamo S, Orciuolo E, Rossi G, Fracchiolla N, Trappolini S, Neri B, Sarlo C, Zappasodi P, Dargenio M, Cefalo M, Irno-Consalvo MA, Conti C, Paterno G, De Angelis G, Sciumè M, Della Starza I, Venditti A, Foà R, Guarini AR. Clinical significance of occult central nervous system disease in adult acute lymphoblastic leukemia. A multicenter report from the campus all network. Haematologica. 2019 Dec 26. pii: haematol.2019.231704. doi: 10.3324/haematol.2019.231704. [Epub ahead of print]

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: January 10, 2019): 241
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: January 10, 2019
• Actual Primary Completion Date: January 1, 2019 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• ALL at onset
• Age >18 years

Exclusion Criteria:

• ALL relapsed or refractory
• Age <18 years

Sex/Gender

• Sexes Eligible for Study: All

• Ages: Child, Adult, Older Adult
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT03803670
• Other Study ID Numbers: RS176/17
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: Maria Ilaria Del Principe, University of Rome Tor Vergata
• Study Sponsor: University of Rome Tor Vergata
• Collaborators: Not Provided

Investigators

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

• PRS Account: University of Rome Tor Vergata
• Verification Date: January 2019