NCT04882475Active, not recruiting
Biological Insights of First Relapsed-refractory Patients With Mantle Cell Lymphoma: the MANTLE-FIRST BIO Study.
Source: ClinicalTrials.gov · Last updated 5 Jan 2026
Brief summary (registry, in English)
Retrospective observational study with a prospective biological evaluation of an historical cohort of first relapsed-refractory patients with mantle cell lymphoma who were relapsed or refractory to rituximab and chemotherapy containing induction regimens with curative intent.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 160 (actual)
- First submitted
- 6 May 2021
- Start date
- 8 Feb 2023
- Primary completion date
- Apr 2026
- Lead sponsor
- Fondazione Italiana Linfomi - ETS
- Diseases
- Mantle cell lymphoma
- NCT number
- NCT04882475
What you commit to
- Study type: Observational
- Participants enrolled: 160
- From 8 Feb 2023 to the primary completion date, Apr 2026
- 16 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients treated with front line regimens containing only rituximab or with palliative therapy;
Other
- Unavailability of the samples requested by the study;
- Any histology other than Mantle Cell Lymphoma (MCL);
- Untreated patients; patients undergoing watchful waiting approach.
Who the study is looking for
- Patients with histologically documented diagnosis of Mantle Cell Lymphoma (MCL) as defined in the 2016 edition of the World Health Organization (WHO) classification, with available tissue for revision and additional studies;
- Diagnosis of Mantle Cell Lymphoma (MCL) between 1st of January 2008 and 30th of June 2020;
- Adults, 18-80 years at diagnosis;
- Relapsed or refractory disease after rituximab and chemotherapy containing induction regimens with curative intent.
- Treatment at relapse or progression on an intention-to-treat basis (ITT): at least one cycle of Chemo-immunotherapy (CIT), Bruton Tyrosine kinase inhibitors (BTKi), or alternative drugs combination;
- Subject understanding and voluntarily signing an informed consent form approved by an Independent Ethics Committee (IEC), prior to the initiation of any study-specific procedures.
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (16)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Centro Riferimento Oncologico - S.O.C. Oncologia Medica A Coordinator of this site? Confirm its status | Aviano | Italy | Unknown status |
| ASST Spedali Civili di Brescia, Ematologia Coordinator of this site? Confirm its status | Brescia | Italy | Unknown status |
| A.O. S. Croce e Carle Coordinator of this site? Confirm its status | Cuneo | Italy | Unknown status |
| Azienda Ospedaliera Universitaria Careggi - Unità funzionale di Ematologia Coordinator of this site? Confirm its status | Florence | Italy | Unknown status |
| ASST Grande Ospedale Metropolitano Niguarda Coordinator of this site? Confirm its status | Milan | Italy | Unknown status |
| AOU Maggiore della Carità di Novara, SCDU Ematologia Coordinator of this site? Confirm its status | Novara | Italy | Unknown status |
| AOU di Padova - Ematologia Coordinator of this site? Confirm its status | Padova | Italy | Unknown status |
| Ospedale Guglielmo da Saliceto - U.O. Ematologia Coordinator of this site? Confirm its status | Piacenza | Italy | Unknown status |
| Azienda Unitа Sanitaria Locale-IRCCS - Arcispedale Santa Maria Nuova - Ematologia - Ematologia Coordinator of this site? Confirm its status | Reggio Emilia | Italy | Unknown status |
| AOU Senese - U.O.C. Ematologia Coordinator of this site? Confirm its status | Siena | Italy | Unknown status |
| A.O.U. Città della Salute e della Scienza di Torino, Ematologia Universitaria Coordinator of this site? Confirm its status | Torino | Italy | Unknown status |
| Ospedale Ca Foncello - S.C di Ematologia Coordinator of this site? Confirm its status | Treviso | Italy | Unknown status |
| Azienda Sanitaria Universitaria Giuliano Isontina (ASUGI) - SC Ematologia Coordinator of this site? Confirm its status | Trieste | Italy | Unknown status |
| Azienda Sanitaria Universitaria Friuli Centrale (ASU FC), SOC Clinica Ematologica Coordinator of this site? Confirm its status | Udine | Italy | Unknown status |
| AOU Integrata di Verona - U.O. Ematologia Coordinator of this site? Confirm its status | Verona | Italy | Unknown status |
| ULSS 8 Berica - Ospedale S. Bortolo, Ematologia Coordinator of this site? Confirm its status | Vicenza | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.