Spots Global Cancer Trial Database for Polatuzumab Vedotin in Combination With Chemotherapy in Subjects With Richter's Transformation

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Trial Identification

Brief Title: Polatuzumab Vedotin in Combination With Chemotherapy in Subjects With Richter's Transformation

Official Title: Phase II Study of Polatuzumab Vedotin in Combination With Chemotherapy in Subjects With Richter's Transformation

Study ID: NCT04679012

Conditions

Richter Syndrome

Chronic Lymphocytic Leukemia

Interventions

Study Description

Brief Summary: This study evaluates the effectiveness and safety of Polatuzumab vedotin plus infusional chemoimmunotherapy containing rituximab, etoposide, prednisone, cyclophosphamide and hydroxydaunorubicin. This is a single arm study. Enrolled patients will receive up to six cycles (21-day cycles) of therapy. While on study, subjects will be monitored weekly until end of treatment, then followed for 52 weeks or until disease progression or discontinuation due to toxicity or death. After completion of the 52-week follow-up/End of study visit, Subjects will be followed for an additional 104 week period, with an assessment occurring every 12 weeks to evaluate survival outcomes and next line of treatments only.

Detailed Description: This is an open label, single arm, phase II investigator initiated clinical trial, evaluating efficacy and safety of Polatuzumab vedotin added to a modified infusional dose adjusted R-EPOCH like regimen, given on an inpatient basis, every 21 days, in subjects with Richter's Transformation.