Clinical trial · Observational
Biological Insights of First Relapsed-refractory Patients With Mantle Cell Lymphoma: the MANTLE-FIRST BIO Study.
NCT04882475CI-TRIAL-00100066active not recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Mantle Cell Lymphoma | Mantle Cell Lymphoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (1)
- label
- MCL patients relapsed or refractory to rituximab and induction chemotherapy with curative intent
- description
- An historical cohort of patients will be identified and selected both on a clinical base and according to the availability of Formaline-fixed paraffin-embedded (FFPE) material, frozen material or viable cryopreserved cells at Mantle Cell Lymphoma (MCL) diagnosis. Samples will be analyzed in 4 subgroups, each with different clinical specificity: 1. refractory to Induction Chemoimmunotherapy (CIT); 2. refractory to Bruton Tyrosine kinase (BTK) inhibitors (BTKi); 3. sensitive to Induction Chemoimmunotherapy (CIT); 4. sensitive to Bruton Tyrosine kinase (BTK) inhibitors (BTKi).
Primary outcomes (1)
- measure
- Histopathological characterization of patients with Mantle Cell Lymphoma (MCL)
- timeFrame
- The endpoint will be evaluated from the beginning to the end of the study (up to 36 months)
- description
- 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.
Secondary outcomes (5)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.