Status:
ACTIVE_NOT_RECRUITING
Biological Insights of First Relapsed-refractory Patients With Mantle Cell Lymphoma: the MANTLE-FIRST BIO Study.
Lead Sponsor:
Fondazione Italiana Linfomi - ETS
Conditions:
Mantle Cell Lymphoma
Eligibility:
All Genders
18-80 years
Brief Summary
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 ri...
Detailed Description
Biological samples from 80 Mantle Cell Lymphoma (MCL) patients will be collected and analyzed in 30 Italian sites in 36 months. Patients will be identified and selected both on a clinical base and ac...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 8 2023
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 1 2026
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT04882475
Start Date
February 8 2023
End Date
April 1 2026
Last Update
January 5 2026
Active Locations (16)
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1
ASST Grande Ospedale Metropolitano Niguarda
Milan, MI, Italy, 20162
2
AOU Senese - U.O.C. Ematologia
Siena, SI, Italy, 53100
3
Centro Riferimento Oncologico - S.O.C. Oncologia Medica A
Aviano, Italy
4
ASST Spedali Civili di Brescia - Ematologia
Brescia, Italy