Mantle Cell LymphomaNCT04600804
The Role of 18F-FDG-PET for Staging and Prognostication
An observational study of Mantle Cell Lymphoma, run by Fondazione Italiana Linfomi - ETS at 34 sites in 2 countries.
Trial summary
A retrospective, multicenter, non-interventional, imaging study ancillary to FIL_MCL0208 clinical trial (NCT02354313) in untreated adult patients with mantle cell lymphoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mantle Cell Lymphoma
- How many people
- 200 participants
- Where
- 34 sitesin 2 countries
- Study dates
- 30 Oct 2020to 11 Jul 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: A total of 300 patients have been enrolled in the MCL0208 trial. We expect to analyze the PETs, clinical and biological data of about 200 patients enrolled in the MCL0208 trial who performed the PET exams within the clinical trial and who consent to the present study: all PETs available at each center participating in this study will be collected and analyzed.
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
34 sites in 2 countries.
34 sites in 2 countries
Italy33 sites
S.C. Ematologia A.O. SS. Antonio e Biagio e Cesare Arrigo
Alessandria, Piedmont, 15121
S.O.C. Oncologia Medica A Centro Riferimento Oncologico
Aviano, Friuli Venezia Giulia, 33081
Divisione di Ematologia e T.M.O. - Ospedale Centrale di Bolzano
Bolzano, Trentino-Alto Adige, 39100
Ematologia ASST Spedali Civili di Brescia
Brescia, Lombardy, 25123
SC Ematologia e CTMO Ospedale Businco
Cagliari, Sardinia, 09121
S.C. di Ematologia e Trapianto di Midollo Osseo A.O. S. Croce e Carle
Cuneo, Piedmont, 12100
Unitа funzionale di Ematologia Azienda Ospedaliera Universitaria Careggi
Florence, Tuscany, 50141
Ematologia Ospedale Policlinico San Martino S.S.R.L. - IRCCS per l Oncologia
Genoa, Liguria, 16132
U.O. Clinica Ematologica Ospedale Policlinico San Martino S.S.R.L. - IRCCS per l Oncologia
Genoa, Liguria, 16132
Ematologia Ospedale Vito Fazzi
Lecce, Apulia, 73100
Ematologia - Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (I.R.S.T.)
Meldola, 47014
S.C. Ematologia Azienda Ospedali Riuniti Papardo-Piemonte
Messina, Sicily, 98158
Ematologia Ospedale Maggiore Policlinico - Fondazione IRCCS Ca Granda
Milan, Lombardy, 20122
SC Ematologia ASST Grande Ospedale Metropolitano Niguarda
Milan, Lombardy, 20162
Unità Linfomi - Dipartimento Oncoematologia - Istituto Scientifico San Raffaele
Milan, Milan
Ematologia ASST MONZA Ospedale S. Gerardo
Monza, Lombardy, 20900
SCDU Ematologia AOU Maggiore della Caritа di Novara
Novara, Piedmont, 28100
Divisione di Ematologia A.O. Ospedali Riuniti Villa Sofia-Cervello
Palermo, Sicily, 90146
Div. di Ematologia IRCCS Policlinico S. Matteo di Pavia
Pavia, Lombardy, 27100
U.O.Ematologia Ospedale Guglielmo da Saliceto
Piacenza, Emilia-Romagna, 29121
U.O. Ematologia - AOU Pisana
Pisa
Ematologia Azienda Unitа Sanitaria Locale-IRCCS - Arcispedale Santa Maria Nuova
Reggio Emilia, Emilia-Romagna, 42123
U.O. di Ematologia Ospedale degli Infermi di Rimini
Rimini, Emilia-Romagna, 47923
Ematologia Universitа Cattolica S. Cuore
Rome, Lazio, 00168
U.O. Ematologia Istituto Clinico Humanitas
Rozzano, Lombardy, 20089
S.C. Oncoematologia A.O. S. Maria di Terni
Terni, Umbria, 05100
S.C di Ematologia Ospedale Ca Foncello
Treviso, Veneto, 31100
U.O.C Ematologia e Trapianto A.O. C. Panico
Tricase, Apulia, 73039
Azienda Sanitaria Universitaria Giuliano Isontina (ASUGI)
Trieste
Ematologia Universitaria A.O.U. Citta della Salute e della Scienza di Torino
Turin, Piedmont, 10126
S.C.Ematologia A.O.U. Citta della Salute e della Scienza di Torino
Turin, Piedmont, 10126
SOC Clinica Ematologica Azienda Sanitaria Universitaria Friuli Centrale (ASU FC)
Udine, Friuli Venezia Giulia, 33100
U.O. Ematologia AOU Integrata di Verona
Verona, Veneto, 37134
About this study
Official title: The Role of 18F-FDG-PET for Staging and Prognostication in Patients Enrolled in the Fondazione Italiana Linfomi (FIL) MCL0208 Trial
A retrospective, multicenter, non-interventional, imaging study ancillary to FIL_MCL0208 clinical trial (NCT02354313) in untreated adult patients with mantle cell lymphoma.
Read the detailed 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.
- Conditions
- Mantle Cell Lymphoma
- Keywords
- prognostic issues, PET review, MCL
- Medical subject headings
- Lymphoma, Mantle-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| All patients registered in the MCL0208 trial | About 200 patients enrolled in the MCL0208 trial who performed the PET exams within the clinical trial and who consent to the present study: all PETs available at each center participating in this study will be collected and analyzed. In the clinical trial PET was optional at baseline (b-PET), before ASCT (i-PET) and after- ASCT (eot-PET). All the PETs available per patient will be collected and considered for analysis, both in the case PET are available at all the 3 time points above listed and in case of availability of PET at 1 or 2 time points only. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 months
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.
Measured: 24months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2020
- Study start30 Oct 2020
- Primary completion26 Oct 2023
- Study completion11 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mantle Cell LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondazione Italiana Linfomi - ETS
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Mian, MD, Principal investigator, Ematologia e Centro Trapianto Midollo Osseo, Ospedale di Bolzano, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04600804
- Sponsor's protocol ID
- FIL_MCL0208-PET
- Status last verified
- May 2026
- First submitted
- 19 Oct 2020
- Last updated
- 1 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of 18F-FDG-PET for Staging and Prognostication in Patients Enrolled in the Fondazione Italiana Linfomi (FIL) MCL0208 Trial
- ClinicalTrials.gov ID
- NCT04600804
- Acronym / sponsor ID
- FIL_MCL0208-PET
- Conditions
- Mantle Cell Lymphoma
- Keywords
- prognostic issues, PET review, MCL
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Fondazione Italiana Linfomi - ETSUniversity, hospital or other
- Study start
- 30 Oct 2020 (actual)
- Primary completion
- 26 Oct 2023 (actual)
- Study completion
- 11 Jul 2025 (actual)
- First posted
- 23 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A retrospective, multicenter, non-interventional, imaging study ancillary to FIL_MCL0208 clinical trial (NCT02354313) in untreated adult patients with mantle cell lymphoma.
Detailed 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.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All patients registered in the MCL0208 trial | – | –About 200 patients enrolled in the MCL0208 trial who performed the PET exams within the clinical trial and who consent to the present study: all PETs available at each center participating in this study will be collected and analyzed. In the clinical trial PET was optional at baseline (b-PET), before ASCT (i-PET) and after- ASCT (eot-PET). All the PETs available per patient will be collected and considered for analysis, both in the case PET are available at all the 3 time points above listed and in case of availability of PET at 1 or 2 time points only. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A total of 300 patients have been enrolled in the MCL0208 trial. We expect to analyze the PETs, clinical and biological data of about 200 patients enrolled in the MCL0208 trial who performed the PET exams within the clinical trial and who consent to the present study: all PETs available at each center participating in this study will be collected and analyzed.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Sensitivity (proportion) and agreement (Cohen K) of PET results (performed in different time points) compared to the current standard (TC plus bone marrow biopsy).
Time frame: 24 months
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.
C-index, estimated comparing models adding or not PET parameters to standard prognostic factors in predicting PFS.
Time frame: 24months
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Mantle Cell Lymphoma
Not yet recruitingPhase 1
Testing the Addition of an Anti-Cancer Drug, Glofitamab, to the Usual Chemotherapy Treatment (Alternating R-CHOP/R-DHAP) for Previously Untreated Mantle Cell Lymphoma
Ann Arbor Stage II Mantle Cell Lymphoma, Ann Arbor Stage III Mantle Cell Lymphoma
RecruitingPhase 3
A Study to Evaluate Glofitamab as a Single Agent vs. Investigator's Choice in Participants With Relapsed/Refractory Mantle Cell Lymphoma
Lymphoma
RecruitingPhase 1
A Study of LY4152199 in Participants With Previously Treated B-cell Malignancies (BAF_FRontier-1 )
Lymphoma, Non-Hodgkin, B-cell Lymphoma
RecruitingPhase 2
Auto Stem Cell Transplant for Lymphoma Patients
Non-Hodgkin Lymphoma, Hodgkin Lymphoma
Active, not recruitingPhase 1
Study to Evaluate Adverse Events, Change in Disease Activity, and How Oral ABBV-101 Moves Through the Body in Adult Participants With B-Cell Malignancies
Hematologic Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Mian, MD principal investigator
Ematologia e Centro Trapianto Midollo Osseo, Ospedale di Bolzano, Italy
34 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mantle Cell Lymphoma, run by Fondazione Italiana Linfomi - ETS at 34 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 34 sites in Italy, Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity (proportion) and agreement (Cohen K) of PET results (performed in different time points) compared to the current standard (TC plus bone marrow biopsy). (time frame: 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2026.