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Biological insights into relapsed-refractory mantle cell lymphoma patients

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

Observational Fondazione Italiana Linfomi - ETS · NCT04882475

This study looks at samples from 80 patients with mantle cell lymphoma who have relapsed after treatment to see if understanding their disease better can help improve future treatments.

Quick facts

Study typeObservational
Enrollment80 (estimated)
Ages18 Years to 80 Years
SexAll
SponsorFondazione Italiana Linfomi - ETS Academic / other
Drugs / interventionsrituximab, chemotherapy, immunotherapy
Locations31 sites (Milano, MI and 30 other locations)
Trial IDNCT04882475 on ClinicalTrials.gov

What this trial studies

This observational study aims to analyze biological samples from 80 patients with mantle cell lymphoma (MCL) who have experienced their first relapse after treatment with rituximab and chemotherapy. Conducted across 30 sites in Italy over 36 months, the study will categorize patients into four subgroups based on their response to previous treatments. The analysis will include central pathology revisions and advanced techniques such as flow cytometry and next-generation sequencing to gain insights into the disease's biological characteristics. The goal is to enhance understanding of MCL in patients who are relapsed or refractory to standard therapies.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-80 with histologically confirmed mantle cell lymphoma who have relapsed or are refractory after initial treatment.

Not a fit: Patients with histologies other than mantle cell lymphoma or those without available biological samples will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved treatment strategies and personalized therapies for patients with mantle cell lymphoma.

How similar studies have performed: While similar studies have explored biological insights in lymphoma, this specific approach focusing on relapsed-refractory mantle cell lymphoma is relatively novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Milano, MI and 30 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Mantle Cell LymphomaMCLfirst relapsed-refractory patientsHistopathological characterizationFlow cytometryNGSGene Expression ProfilingRNA
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.