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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria:
* 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.
Exclusion Criteria:
* Unavailability of the samples requested by the study;
* Any histology other than Mantle Cell Lymphoma (MCL);
* Patients treated with front line regimens containing only rituximab or with palliative therapy;
* Untreated patients; patients undergoing watchful waiting approach.
Primary outcome measure(s)
Histopathological characterization of patients with Mantle Cell Lymphoma (MCL) — The endpoint will be evaluated from the beginning to the end of the study (up to 36 months) Histopathological characterization of patients with mantle cell lymphoma (MCL) who were relapsed or refractory to rituximab and chemotherapy containing induction regimens with curative intent. 80 Mantel Cell Lymphoma (MCL) patients stratified according to Chemo-immunotherapy (CIT) or Bruton Tyrosine kinase inhibitors (BTKi) resistance (20 for each of the groups previously identified) will undergo central pathology revision with assessment of Immunoglobulin (Ig) expression and other histopathological studies.
Trial sites (16)
Facility
City
Region
Status
ASST Grande Ospedale Metropolitano Niguarda
Milan
MI
AOU Senese - U.O.C. Ematologia
Siena
SI
Centro Riferimento Oncologico - S.O.C. Oncologia Medica A
Aviano
Italy
ASST Spedali Civili di Brescia - Ematologia
Brescia
Italy
A.O. S. Croce e Carle
Cuneo
Italy
Azienda Ospedaliera Universitaria Careggi- Unità funzionale di ematologia
Florence
Italy
AOU Maggiore della Carità di Novara - SCDU Ematologia
Novara
Italy
AOU di Padova - Ematologia
Padova
Italy
Ospedale Guglielmo da Saliceto - U.O.Ematologia
Piacenza
Italy
Azienda Unitа Sanitaria Locale-IRCCS - Arcispedale Santa Maria Nuova - Ematologia - Ematologia
Reggio Emilia
Italy
A.O.U. Citta della Salute e della Scienza di Torino- Ematologia Universitaria
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time.
