A Czech Lymphoma Study Group, phase II, open-label, study of polatuzumab-vedotin in combination with bendamustine and rituximab for patients with mantle cell lymphoma, who relapse after previous therapy with Bruton tyrosine kinase inhibitor
Signed written Informed Consent Form
Adult patients with relapsed or refractory MCL after failure of BTK inhibitor-containing therapy (e.g. ibrutinib, acalabrutinib, zanubrutinib)
Patients previously treated with bendamustine are eligible for the study treatment, in the case they had achieved objective response (CR or PR) and the last dose of bendamustine was administered ≥ 1 year before the estimated study treatment initiation date (C1D1)
Tumor tissue at the lymphoma relapse after failure of BTK inhibitor. In case that a re-biopsy is not possible (e.g. urgent need to start study treatment), archival tissue blocks may be used to confirm the diagnosis
Prior organ transplantation
Current Grade ≥ 2 peripheral neuropathy by clinical examination or demyelinating form of Charcot-Marie-Tooth disease
History of other malignancy that could affect compliance with the protocol or interpretation of results Patients with a history of curatively treated basal or squamous cell carcinoma or melanoma of the skin or in situ carcinoma of the cervix at any time prior to the study are eligible Patients with any malignancy appropriately treated with curative intent and the malignancy has been in remission without treatment for ≥ 2 years prior to enrollment are eligible Patients with low-grade, early-stage prostate cancer (Gleason score 6 or below, Stage
Evidence of significant, uncontrolled, concomitant diseases that could affect compliance with the protocol or interpretation of results.
Single group
Polatuzumab vedotin
Drugtreatment by a study drug polatuzumab-vedotin, i.v.
Bendamustine Hydrochloride
Drugtreatment by a study drug bendamustin i.v.
Rituximab
Drugtreatment by a study drug rituximab, i.v.
Progression-free survival (PFS)
evaluation of the efficacy of the combination of polatuzumab vedotin plus bendamustine and rituximab (BR) with respect to progression-free survival (PFS)
overall response rate (ORR)
efficacy of polatuzumab vedotin plus BR with respect to overall response rate
duration of response (DoR)
efficacy of PV plus BR with respect to duration of response
event free survival (EFS)
efficacy of PV plus BR with respect to event free survival
overall survival (OS)
efficacy of PV plus BR with respect to overall survival
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