Lymphoma, Mantle-Cell Clinical Trial
Official title:
Rituximab, Bendamustine and Cytarabine Followed by Venetoclax (V-RBAC) in High-risk Elderly Patients With Mantle Cell Lymphoma (MCL)
Verified date | June 2024 |
Source | Fondazione Italiana Linfomi - ETS |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Prospective, multicenter, phase II trial designed to evaluate whether the addition of Venetoclax after rituximab, bendamustine and cytarabine (R-BAC) to high risk patients with mantle cell lymphoma improves the results of the standard R-BAC, in terms of Progression Free Survival.
Status | Active, not recruiting |
Enrollment | 141 |
Est. completion date | July 2025 |
Est. primary completion date | July 26, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Previously untreated patients with MCL aged =65 years if they are FIT according to the geriatric CGA assessment. 2. age =64 years not eliglible to high-dose chemotherapy plus transplantation at physician's judgement (details for non eligibility to be recorded by means of the CIRS, Cumulative Illness rating Scale). 3. Measurable nodal or extranodal disease = 1.5 cm in longest diameter, and measurable in 2 perpendicular dimensions. 4. ECOG performance status =2. 5. Positivity for cyclin D1 and/or SOX11 [the latter being mandatory in cases lacking cyclin D1- or t(11;14)-negative]. 6. Adequate renal function (Creatinine clearance >50 mL/min), with preserved diuresis. 7. Adequate liver function: alanine aminotransferase (ALT)/aspartate aminotransferase (AST) <2.5 x upper limit of normal (ULN) value, total bilirubin <1.5 x ULN, unless directly attributable to the patient's tumor or to congenital causes. 8. Hepatitis B core antibody (HBcAb) positive/HBsAg negative/HBV-DNA negative patients may be enrolled if correct antiviral prophylaxis is administered at least 2 weeks before initiating protocol treatment. 9. Written informed consent. Exclusion Criteria: 1. Human immunodeficiency virus (HIV) positive. 2. Previous treatment for lymphoma. 3. Disease confined to the bone marrow/peripheral blood/spleen, without any other nodal or extranodal involvement. 4. In-situ MCL. 5. Medical conditions or organ injuries that could interfere with administration of therapy. 6. Active bacterial, viral, or fungal infection requiring systemic therapy. 7. Seizure disorders requiring anticonvulsant therapy. 8. Severe chronic obstructive pulmonary disease with hypoxiemia. 9. History of severe cardiac disease: New York Heart Association (NYHA) functional class III-IV, myocardial infarction within 6 months, ventricular tachyarrhythmias, dilatative cardiomyopathy, or unstable angina. 10. Uncontrolled diabetes mellitus. 11. Active secondary malignancy. 12. Known hypersensitivity or anaphylactic reactions to murine antibodies and proteins, to Bendamustine or mannitol. 13. Major surgery within 4 weeks of study Day 1. 14. HBsAg+ 15. HCVAb+ patients with active viral replication (HCV-RNA+ with AST>2 x normal limit) 16. Any co-existing medical or psychological condition that would preclude participation in the study or compromise the patient's ability to give informed consent, or that may affect the interpretation of the results, or render the patient at high risk from treatment complications. 17. CNS involvement 18. Chronic treatment with strong or moderate CYP3A inhibitors (e.g. ketoconazole, ritonavir, clarithromycin, itraconazole, voriconazole) |
Country | Name | City | State |
---|---|---|---|
Italy | A.O. SS. Antonio e Biagio e Cesare Arrigo, SC Ematologia | Alessandria | |
Italy | Università Politecnica delle Marche, Clinica di Ematologia | Ancona | |
Italy | Centro Riferimento Oncologico, S.O.C. Oncologia Medica A | Aviano | |
Italy | IRCCS Istituto Tumori Giovanni Paolo II, UOC Ematologia | Bari | |
Italy | Policlinico S. Orsola-Malpighi, Istituto di Ematologia "Seragnoli" | Bologna | |
Italy | ASST Spedali Civili, Ematologia | Brescia | |
Italy | Ospedale Businco, Ematologia | Cagliari | |
Italy | Azienda Ospedaliera S. Croce e Carle, SC Ematologia | Cuneo | |
Italy | Azienda Ospedaliera Universitaria Careggi, Unità funzionale di Ematologia | Firenze | |
Italy | Ospedale Policlinico San Martino S.S.R.L. - IRCCS per l'Oncologia, Clinica Ematologica | Genova | |
Italy | Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (I.R.S.T.), Ematologia | Meldola | |
Italy | ASST Grande Ospedale Metropolitano Niguarda, SC Ematologia | Milano | |
Italy | Fondazione IRCCS Istituto Nazionale dei Tumori di Milano, Ematologia | Milano | |
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 | Azienda Ospedaliera Universitaria di Padova, Ematologia | Padova | |
Italy | A.O. Ospedali Riuniti Villa Sofia-Cervello, Divisione di Ematologia | Palermo | |
Italy | IRCCS Policlinico S. Matteo, Divisione di Ematologia | Pavia | |
Italy | Ospedale Guglielmo Da Saliceto, UO Ematologia | Piacenza | |
Italy | Ospedale delle Croci, Ematologia | Ravenna | |
Italy | Grande Ospedale Metropolitano Bianchi Melacrino Morelli, Ematologia | Reggio Calabria | |
Italy | Azienda Unità Sanitaria Locale-IRCCS - Arcispedale Santa Maria Nuova, Ematologia | Reggio Emilia | |
Italy | Ospedale degli Infermi, UO Ematologia | Rimini | |
Italy | Policlinico Umberto I - Università "La Sapienza", Istituto Ematologia -Dipartimento di Biotecnologie Cellulari ed Ematologia | Roma | |
Italy | Università Cattolica S. Cuore, Ematologia | Roma | |
Italy | Istituto Clinico Humanitas, UO Ematologia | Rozzano | |
Italy | A.O.U. Città della Salute e della Scienza di Torino, SC Ematologia | Torino | |
Italy | A.O.U. Città della Salute e della Scienza di Torino, SC Ematologia Universitaria | Torino | |
Italy | Ospedale Ca' Foncello, SC Ematologia | Treviso | |
Italy | Azienda Ospedaliera C. Panico, UOC Ematologia e Trapianto | Tricase | |
Italy | Azienda Sanitaria Universitaria Integrata di Udine, Clinica Ematologica | Udine | |
Italy | Ospedale di Circolo, UOC Ematologia | Varese | |
Italy | Azienda Ospedaliera Universitaria Integrata di Verona, UO Ematologia | Verona | |
Italy | Ospedale San Bortolo, Divisione di Ematologia | Vicenza |
Lead Sponsor | Collaborator |
---|---|
Fondazione Italiana Linfomi - ETS | AbbVie |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Progression-free survival of the High Risk patients | 2-years progression-free survival (PFS) of the HR patients from date of enrollment | 24 months | |
Secondary | Molecular response | The proportion of molecular response (analyzed in the labs of the FIL- MRD Network) | 10 months and 30 months | |
Secondary | Progression-free survival of all patients and different subgroups | The progression-free survival (PFS) of all enrolled patients, and of different subgroups (i.e TP53 mutated patients) | 24 months | |
Secondary | Overall survival | Overall survival | 54 months | |
Secondary | Duration of responses | Duration of responses | 24 months | |
Secondary | Proportion of complete remission in High Risk and Law Risk patients | The proportion of complete remission (CR) before and after venetoclax in the HR group and/or in the LR not responding to R-BAC | 6 months and 10 months | |
Secondary | Completed expected treatment schedule | The proportion of patients that complete the expected treatment schedule | 30 months | |
Secondary | Incidence of Treatment-Emergent Adverse Events | The proportion of patients with adverse events as assessed by CTCAE 4.03 during venetoclax administration as consolidation or maintenance after R-BAC | 10 months and 30 months |
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