Biological Insights of First Relapsed-refractory Patients With Mantle Cell Lymphoma: the MANTLE-FIRST BIO Study.

Plain-language summary

This study aims to examine the biological features of disease in patients with first relapsed or refractory mantle cell lymphoma. It enrolls adults aged 18-80 diagnosed between 2008 and 2020 whose disease relapsed or was refractory after rituximab- and chemotherapy-containing regimens and for whom tissue samples are available. It is conducted as a study without a phase designation and is active but not currently recruiting.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

N/A

Status

Active, not recruiting

Sponsor

Fondazione Italiana Linfomi - ETS

Start date

2/8/2023

Estimated completion

4/1/2026

Countries

Italy

Related genes

Locations

• Milan, Italy
• Siena, Italy
• Aviano, Italy
• Brescia, Italy
• Cuneo, Italy
• Florence, Italy
• Novara, Italy
• Padova, Italy
• Piacenza, Italy
• Reggio Emilia, Italy
• Torino, Italy
• Treviso, Italy
• Trieste, Italy
• Udine, Italy
• Verona, Italy
• Vicenza, Italy

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

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.