Status:
COMPLETED
Observational Study for the Cytofluorimetric Analysis of Cerebrospinal Fluid in Non-Hodgkin's Lymphoma Patients
Lead Sponsor:
Gruppo Italiano Multiregionale per lo studio dei Linfomi e delle Leucemie
Collaborating Sponsors:
Centro di Riferimento per l'Epidemiologia e la Prev. Oncologica Piemonte
Conditions:
Diffuse Large Cell Lymphoma
Lymphoblastic Lymphoma
Eligibility:
All Genders
18+ years
Brief Summary
The purpose of this study is to define if flow cytometry has more sensitivity for detecting neoplastic cells in cerebrospinal fluid versus conventional cytology.
Detailed Description
Aggressive B-cell non-Hodgkin's lymphoma (B-NHL), Lymphoblastic Lymphoma and Burkitt's Lymphoma are at high risk of CNS relapse. For this reason is recommended a prophylaxis therapy. This suggests tha...
Eligibility Criteria
Inclusion
- Diagnosis of
- Diffuse large cell lymphoma HIV positive,
- Lymphoblastic lymphoma,
- Burkitt's lymphoma,
- Mantle cell lymphoma blastoid type.
- DLCL patients who presented one risk factor for leptomeningeal involvement as:
- testis, bone marrow, orbit, palate, paranasal cavity or peridural disease localization,
- 2-3 age-adjusted IPI score with more than 1 extranodal site and LDH \> normal.
- Patients with cytologic and flow cytometry on cerebrospinal fluid at diagnosis.
Exclusion
- 1\. Patients with clinical or strumental evidence of meningeal localization disease.
Key Trial Info
Start Date :
July 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 1 2012
Estimated Enrollment :
175 Patients enrolled
Trial Details
Trial ID
NCT00949741
Start Date
July 1 2009
End Date
October 1 2012
Last Update
October 22 2013
Active Locations (12)
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1
ASO SS Antonio e Biagio e Cesare Arrigo
Alessandria, AL, Italy, 15100
2
PO Centro Binaghi Divisione di Ematologia CTMO
Cagliari, CA, Italy, 09121
3
Az. Ospedaliero Universitaria Careggi
Florence, FI, Italy, 50134
4
Ospedale Vito Fazzi Divisione di Ematologia
Lecce, LE, Italy, 73100