Non Hodgkin Lymphoma Clinical Trial
A Phase 1/2, Open-Label, Dose Escalation, Safety and Tolerability Study of INCB050465 and Itacitinib in Subjects With Previously Treated B-Cell Malignancies (CITADEL-101)
Open-label, dose-escalation study in subjects with previously treated B-cell malignancies to find maximum tolerated dose (MTD) or pharmacologic active dose of a PI3KÎ´ inhibitor, parsaclisib, as monotherapy and in combination with: itacitinib (INCB039110), a JAK1 inhibitor; rituximab; and rituximab, ifosfamide, carboplatin, and etoposide. Parsaclisib inhibits PI3KÎ´, a protein involved in growth and survival of B-cell cancer cells.
Aged 18 years or older, with lymphoid malignancies of B-cell origin including:
Indolent / aggressive B-cell non-Hodgkin's lymphoma (NHL)
EXCLUDING: Burkitt's lymphoma and precursor B lymphoblastic leukemia/lymphoma
INCLUDING: any non-Hodgkin's B cell malignancy such as chronic lymphocytic leukemia (CLL) and rare non-Hodgkin's B- cell subtypes such as hairy cell leukemia, Waldenström macroglobulinemia (WM), mantle cell leukemia (MCL), and transformed NHL histologies
Hodgkin's lymphoma (HL)
Life expectancy of 12 weeks or longer
Subject must have received ≥ 1 prior treatment regimen(s)
The subject must not be a candidate for potentially curative therapy including hematopoietic stem cell transplantation, except where one of the standard therapy regimen combinations may be used prior to transplantation per standard medical practice
Has history of brain metastasis, spinal cord compression (unless treated, asymptomatic, and stable on most recent imaging and enrolling in expansion cohort), or lymphoma involving the central nervous system (CNS)
Has an Eastern Cooperative Oncology Group (ECOG) performance status of ≥ 3 (≥ 2 during dose escalation)
Received allogeneic hematopoietic stem cell transplant within the last 6 months, or has active graft versus host disease (GVHD) following allogeneic transplant, or currently receiving immunosuppressive therapy following allogeneic transplant
Received autologous hematopoietic stem cell transplant within the last 3 months
Inadequate marrow reserve assessed by hematologic laboratory parameters
Inadequate renal or liver function
Known HIV infection, or hepatitis B virus (HBV) or hepatitis C virus (HCV) viremia or at risk for HBV reactivation
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There are 7 Locations for this study
Birmingham Alabama, 35205, United States
Ann Arbor Michigan, 48109, United States
Detroit Michigan, 48201, United States
New York New York, 10016, United States
Cleveland Ohio, 44106, United States
Greenville South Carolina, 29605, United States
Dallas Texas, 75246, United States
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