The Role of 18F-FDG-PET for Staging and Prognostication

Mantle Cell Lymphoma Clinical Trial

Official title:

The Role of 18F-FDG-PET for Staging and Prognostication in Patients Enrolled in the Fondazione Italiana Linfomi (FIL) MCL0208 Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04600804
• Other study ID #: FIL_MCL0208-PET
• Status: Active, not recruiting
• Start date: October 30, 2020
• Est. completion date: January 2024

Study information

• Verified date: December 2023
• Source: Fondazione Italiana Linfomi - ETS
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

A retrospective, multicenter, non-interventional, imaging study ancillary to FIL_MCL0208 clinical trial (NCT02354313) in untreated adult patients with mantle cell lymphoma.

Description:

This is a retrospective, multicenter, non-interventional, imaging study devoted to patients diagnosed with MCL and enrolled in the MCL0208 international randomized, phase III clinical trial (NCT02354313). The study is aimed at addressing a number of prognostic issues that still need to be clarified in MCL patients, by taking advantage of the PET performed within the MCL0208 trial and available for the analysis, and the clinical records and molecular data generated in the context of the trial. In the clinical trial PET was optional at baseline (b-PET), before ASCT (i-PET) and after-ASCT (eot-PET), and none of the exams was used in the decisionmaking strategy. All the PETs available will be collected and considered for analysis. The study will not require additional treatment or procedures except those required for the MCL0208 trial. The participation of the patient to the MCL0208 trial is a pre-requisite to be involved in this study.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. completion date: January 2024
• Est. primary completion date: October 26, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Enrollment of the patient in the MCL0208 clinical trial documented by the signature of the study informed consent;
• Patient's treatment in one of the centers that participated in the MCL0208 trial and that has joined the MCL0208-PET study as well;
• Evidence of signed informed consent for the MCL0208-PET study.

Related Conditions & MeSH terms

• Lymphoma, Mantle-Cell
• Mantle Cell Lymphoma

Locations

Country	Name	City	State
Italy	S.C. Ematologia A.O. SS. Antonio e Biagio e Cesare Arrigo	Alessandria	Piedmont
Italy	S.O.C. Oncologia Medica A Centro Riferimento Oncologico	Aviano	Friuli Venezia Giulia
Italy	Divisione di Ematologia e T.M.O. - Ospedale Centrale di Bolzano	Bolzano	Trentino Alto Adige
Italy	Ematologia ASST Spedali Civili di Brescia	Brescia	Lombardy
Italy	SC Ematologia e CTMO Ospedale Businco	Cagliari	Sardinia
Italy	S.C. di Ematologia e Trapianto di Midollo Osseo A.O. S. Croce e Carle	Cuneo	Piedmont
Italy	Unit? funzionale di Ematologia Azienda Ospedaliera Universitaria Careggi	Firenze	Tuscany
Italy	Ematologia Ospedale Policlinico San Martino S.S.R.L. - IRCCS per l Oncologia	Genova	Liguria
Italy	U.O. Clinica Ematologica Ospedale Policlinico San Martino S.S.R.L. - IRCCS per l Oncologia	Genova	Liguria
Italy	Ematologia Ospedale Vito Fazzi	Lecce	Puglia
Italy	Ematologia - Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (I.R.S.T.)	Meldola
Italy	S.C. Ematologia Azienda Ospedali Riuniti Papardo-Piemonte	Messina	Sicily
Italy	Ematologia Ospedale Maggiore Policlinico - Fondazione IRCCS Ca Granda	Milano	Lombardia
Italy	SC Ematologia ASST Grande Ospedale Metropolitano Niguarda	Milano	Lombardia
Italy	Unità Linfomi - Dipartimento Oncoematologia - Istituto Scientifico San Raffaele	Milano	Milan
Italy	Ematologia ASST MONZA Ospedale S. Gerardo	Monza	Lombardia
Italy	SCDU Ematologia AOU Maggiore della Carit? di Novara	Novara	Piedmont
Italy	Divisione di Ematologia A.O. Ospedali Riuniti Villa Sofia-Cervello	Palermo	Sicily
Italy	Div. di Ematologia IRCCS Policlinico S. Matteo di Pavia	Pavia	Lombardia
Italy	U.O.Ematologia Ospedale Guglielmo da Saliceto	Piacenza	Emilia Romagna
Italy	U.O. Ematologia - AOU Pisana	Pisa
Italy	Ematologia Azienda Unit? Sanitaria Locale-IRCCS - Arcispedale Santa Maria Nuova	Reggio Emilia	Emilia Romagna
Italy	U.O. di Ematologia Ospedale degli Infermi di Rimini	Rimini	Emilia Romagna
Italy	Ematologia Universit? Cattolica S. Cuore	Roma	Latium
Italy	U.O. Ematologia Istituto Clinico Humanitas	Rozzano	Lombardia
Italy	S.C. Oncoematologia A.O. S. Maria di Terni	Terni	Umbria
Italy	S.C di Ematologia Ospedale Ca Foncello	Treviso	Veneto
Italy	U.O.C Ematologia e Trapianto A.O. C. Panico	Tricase	Puglia
Italy	Azienda Sanitaria Universitaria Giuliano Isontina (ASUGI)	Trieste
Italy	Ematologia Universitaria A.O.U. Citta della Salute e della Scienza di Torino	Turin	Piedmont
Italy	S.C.Ematologia A.O.U. Citta della Salute e della Scienza di Torino	Turin	Piedmont
Italy	SOC Clinica Ematologica Azienda Sanitaria Universitaria Friuli Centrale (ASU FC)	Udine	Friuli Venezia Giulia
Italy	U.O. Ematologia AOU Integrata di Verona	Verona	Veneto
Portugal	Instituto Português de Oncologia de Lisboa	Lisboa

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Italiana Linfomi - ETS

Countries where clinical trial is conducted

Italy,  Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity (proportion) and agreement (Cohen K) of PET results (performed in different time points) compared to the current standard (TC plus bone marrow biopsy).	To better define the role of PET for the staging of MCL patients at the time of diagnosis, for evaluation of response after induction treatment (pre-ASCT; i-PET) and post ASCT (eot-PET) in comparison to the current standards, namely computed axial tomography (CT) and bone marrow biopsy.	24 months
Primary	C-index, estimated comparing models adding or not PET parameters to standard prognostic factors in predicting PFS.	To build a new prognostic model for PFS, including PET parameters, MIPI-b and biological data (e.g. MRD, GEP and mutational parameters).The achievement of these objectives could help to plan futures studies in order to improve the outcome of MCL patients.	24months