Polatuzumab Vedotin and Combination Chemotherapy for the Treatment of Previously Untreated Double or Triple Hit Lymphoma

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PRIMARY OBJECTIVE: I. To determine the rate of complete remission (CR) with polatuzumab vedotin plus rituximab, cyclophosphamide, doxorubicin hydrochloride, and prednisone (R-CHP) in patients with newly diagnosed previously untreated double or triple hit lymphoma as measured by positron emission tom...

PRIMARY OBJECTIVE: I. To determine the rate of complete remission (CR) with polatuzumab vedotin plus rituximab, cyclophosphamide, doxorubicin hydrochloride, and prednisone (R-CHP) in patients with newly diagnosed previously untreated double or triple hit lymphoma as measured by positron emission tomography (PET)-defined CR rate using the modified Lugano response criteria at the time of primary response assessment (6-8 weeks after cycle 6 day 1 or last dose of study medication). PRIMARY OBJECTIVE: I. To determine the rate of complete remission (CR) with polatuzumab vedotin plus rituximab, cyclophosphamide, doxorubicin hydrochloride, and prednisone (R-CHP) in patients with newly diagnosed previously untreated double or triple hit lymphoma as measured by positron emission tomography (PET)-defined CR rate using the modified Lugano response criteria at the time of primary response assessment (6-8 weeks after cycle 6 day 1 or last dose of study medication). SECONDARY SAFETY OBJECTIVE: I. To evaluate the safety and tolerability of the combination of polatuzumab vedotin (PoV) plus R-CHP as defined by Common Terminology Criteria for Adverse Events (CTCAE) 5.0. SECONDARY EFFICACY OBJECTIVES: I. To assess the progression free survival (PFS) with PoV plus R-CHP in the above-mentioned patient population. II. To assess the overall survival (OS) with PoV plus R-CHP in the above-mentioned patient population. III. To assess the overall response rate (ORR; complete response [CR] or partial response [PR]) at the time of primary response assessment, based on modified Lugano PET-computed tomography (CT) criteria, as determined by the investigator. IV. To assess the duration of response (DOR) to PoV plus R-CHP based on PET-CT, as determined by the investigators in the above-mentioned patient population. EXPLORATORY OBJECTIVES: I. To explore the relationship between CD79b expression and response to treatment with PoV plus R-CHP. II. To explore the relationship between MYC expression and response to treatment with PoV plus R-CHP. III. To explore polatuzumab vedotin treatment on Myc protein expression. OUTLINE: Patients receive prednisone orally (PO), prednisolone intravenously (IV), or methylprednisolone IV on days 1-5. Patients also receive rituximab IV, polatuzumab vedotin IV over 30-90 minutes, cyclophosphamide IV, and doxorubicin hydrochloride IV on day 1. Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3 months for 12 months.

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