Ruxolitinib in Combination With CHOP Chemotherapy for the Treatment of Untreated Nodal T-Follicular Helper Cell Lymphomas

PRIMARY OBJECTIVE: I. Determine the safety of ruxolitinib phosphate (ruxolitinib) in combination with CHOP chemotherapy in untreated nodal TFH cell lymphoma patients. SECONDARY OBJECTIVES: I. Determine the tolerability and preliminary clinical efficacy of Ia. Ruxolitinib in combination with CHOP chemotherapy in untreated nodal TFH cell lymphoma; Ib. Ruxolitinib monotherapy maintenance for nodal TFH cell lymphoma patients who achieve a response (partial response \[PR\] or complete response \[CR\]) with ruxolitinib + CHOP chemotherapy. EXPLORATORY OBJECTIVES: I. Describe preliminary survival outcomes. II. Describe the relative dose intensity of CHOP chemotherapy backbone. OUTLINE: PART A: Patients receive ruxolitinib orally (PO) twice daily (BID) on days 1-21, cyclophosphamide intravenously (IV), doxorubicin IV, vincristine IV, on day 1 and prednisone PO once daily (QD) on days 1-5 of each cycle. Patients also receive pegfilgrastim subcutaneously (SC) 24-72 hours after last dose of treatment, filgrastim SC starting 1 day after last dose of treatment until absolute neutrophil count (ANC) \> 1000/uL. Cycles repeat every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients who achieve a PR or CR and are ineligible for or decline consolidative autologous stem cell transplantation (ASCT) proceed to Part B. PART B: Patients receive ruxolitinib PO BID on days 1-28 of each cycle. Cycles repeat every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. After the first year of monotherapy maintenance, patients who remain in continuous CR or PR (compared to baseline imaging before Part A) may optionally continue to receive ruxolitinib for an additional 12 cycles. Additionally, patients undergo bone marrow biopsy and aspiration and multigated acquisition scan (MUGA) or echocardiography (ECHO) at screening, blood sample collection, fludeoxyglucose F-18 (FDG)-positron emission tomography (PET)/computed tomography (CT) and CT throughout the study. After completion of study treatment, patients are followed up at 30 days then for up to 5 years.