Polatuzumab Vedotin and Combination Chemotherapy for the Treatment of Previously Untreated Lymphoma

Description

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, triple hit lymphoma, Double Expressor Lymphoma or High-Grade B Cell 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, triple hit lymphoma, Double Expressor Lymphoma or High-Grade B Cell 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.