Spots Global Cancer Trial Database for Biological Insights of First Relapsed-refractory Patients With Mantle Cell Lymphoma: the MANTLE-FIRST BIO Study.
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Trial Identification
Brief Title: Biological Insights of First Relapsed-refractory Patients With Mantle Cell Lymphoma: the MANTLE-FIRST BIO Study.
Official Title: Biological Insights of First Relapsed-refractory Patients With Mantle Cell Lymphoma: the MANTLE-FIRST BIO Study.
Study ID: NCT04882475
Conditions
Interventions
Study Description
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 rituximab and chemotherapy containing induction regimens with curative intent.
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 according to the availability of Formaline-fixed paraffin-embedded (FFPE) material, frozen material or viable cryopreserved cells at Mantle Cell Lymphoma (MCL) diagnosis. They 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 Induction Chemoimmunotherapy (CIT); 4) sensitive to BTK inhibitors (BTKi). Each group will undergo central pathology revision with other immunohistochemical studies (Verona, Dr. Parisi; Milano, Prof. Ponzoni; Vicenza, Dr. D'Amore; Brescia, Prof. Facchetti). Formaline-fixed paraffin-embedded (FFPE) diagnostic specimens of Mantle Cell Lymphoma (MCL) will be screened by immunohistochemistry for the expression of immunoglobulin (Ig) heavy chains to identify Mantle Cell Lymphoma (MCL) cases lacking Immunoglobulin (Ig) expression. Cytofluorimetric and molecular studies will be performed in the laboratories of the Verona University and at IFOM (Istituto FIRC di Oncologia Molecolare (FIRC = Fondazione Italiana per la Ricerca sul Cancro)). Specific methods will be used: Flow cytometry for the status of surface Ig expression and multiplexed phospho-specific flow cytometry, NGS (Next Generation Sequencing), Immunoglobulin (IgH/IgL V(D)J) profiling by BIOMED2 protocol-based, NGS (Next Generation Sequencing) technology in the relapsed-refractory mantle cell lymphoma (R/R MCL) cases, Chromatin accessibility studies by Assay for Transposase-Accessible Chromatin sequencing (ATAC-seq) (on viable cell suspensions or frozen pellets) and Gene Expression Profiling (GEP) by RNA-sequencing and RNA studies of the MALT1-MYC ((Mucosa-associated lymphoid tissue lymphoma translocation protein 1 - MYC) pathway.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
ASST Grande Ospedale Metropolitano Niguarda, Milano, MI, Italy
P.O. Spirito Santo di Pescara - UOS Dipartimentale - Centro di diagnosi e Terapia dei linfomi, Pescara, PE, Italy
AOU Senese - U.O.C. Ematologia, Siena, SI, Italy
A.O. SS. Antonio e Biagio e Cesare Arrigo, SC Ematologia, Alessandria, , Italy
AOU Ospedali Riuniti - Clinica di Ematologia, Ancona, , Italy
Centro Riferimento Oncologico - S.O.C. Oncologia Medica A, Aviano, , Italy
AOU Policlinico Consorziale - U.O. Ematologia con Trapianto, Bari, , Italy
IRCCS Istituto Tumori Giovanni Paolo II - U.O.C Ematologia, Bari, , 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, Firenze, , Italy
Ospedale Vito Fazzi - Ematologia, Lecce, , Italy
Istituto Scientifico San Raffaele - Unità Linfomi - Dipartimento Oncoematologia, Milano, , Italy
Ospedale Maggiore Policlinico - Fondazione IRCCS Ca Granda - Ematologia, Milano, , Italy
AOU Maggiore della Carità di Novara - SCDU Ematologia, Novara, , Italy
AOU di Padova - Ematologia, Padova, , Italy
IRCCS Policlinico S. Matteo di Pavia - Div. di Ematologia, Pavia, , Italy
Ospedale Guglielmo da Saliceto - U.O.Ematologia, Piacenza, , Italy
Azienda Unitа Sanitaria Locale-IRCCS - Arcispedale Santa Maria Nuova - Ematologia - Ematologia, Reggio Emilia, , Italy
Ospedale degli Infermi di Rimini - U.O. di Ematologia, Rimini, , Italy
Policlinico Umberto I - Universitа "La Sapienza" - Istituto Ematologia -Dipartimento di Medicina Traslazionale e di Precisione, Roma, , Italy
Universitа Cattolica S. Cuore - Ematologia, Roma, , Italy
A.O.U. Citta della Salute e della Scienza di Torino - S.C.Ematologia, Torino, , Italy
A.O.U. Citta della Salute e della Scienza di Torino- Ematologia Universitaria, Torino, , Italy
Ospedale S. Chiara - S.S. di Ematologia, Trento, , Italy
Ospedale Ca' Foncello - S.C di Ematologia, Treviso, , Italy
Azienda Sanitaria Universitaria Giuliano Isontina (ASUGI) - SC Ematologia, Trieste, , Italy
Azienda Sanitaria Universitaria Friuli Centrale (ASU FC) - SOC Clinica Ematologica, Udine, , Italy
Ospedale di Circolo - U.O.C Ematologia, Varese, , Italy
AOU Integrata di Verona - U.O. Ematologia, Verona, , Italy
ULSS 8 Berica - Ospedale S. Bortolo - Ematologia, Vicenza, , Italy
Contact Details
Name: Francesca Maria Quaglia
Affiliation: Azienda Ospedaliera Universitaria (AOU) Integrata di Verona - Unità Operativa di Ematologia
Role: PRINCIPAL_INVESTIGATOR
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