Cancer Type: Malignant Hematology
Study Type: Treatment
Phase: Phase II
Principal Investigator: Jain, Michael
A Phase 2, Single-Arm, Open-Label Study using Itacitinib as Pre-Modulation in Patients with Diffuse Large B-Cell Lymphoma (DLBCL) Receiving CAR-T-Cell Therapy
The purpose of the study is to assess the safety and efficacy of once daily itacitinib oral administration in participants with diffuse large B-cell lymphoma (DLBCL) who will receive CAR-T cell therapy with axicabtagene ciloleucel (axi-cel).
Primary: -To assess safety, tolerability, and efficacy of itacitinib in conjunction with axicabtagene ciloleucel (Axi-cel) CAR-T-cell therapy in subjects with diffuse large B-cell lymphoma (DLBCL). -To investigate whether a pre-modulation strategy using itacitinib in conjunction with axi-cel improves the 6-month progression-free survival (PFS) from 25% to 45% in patients who express high levels of systemic inflammation. Secondary Objectives: -To investigate the effect of pre-modulation with itacitinib on the lymphoma tumor microenvironment. -To investigate the effect of pre-modulation with itacitinib on safety including occurrence of cytokine release syndrome (CRS) and immune effector cell associated neurotoxicity syndrome (ICANS). -To investigate response rates, PFS and OS in patients treated with itacitinib and axi-cel.
Chemotherapy (NOS); Immunotherapy; Therapy (NOS)
Anakinra (); Axicabtagene Ciloleucel (Yescarta); Itacitinib (); Tocilizumab (); cyclophosphamide (); cytoxan (cyclophosphamide); fludarabine (Fludarabine phosphate)
If you are interested in learning more about clinical trials, our clinical trial navigators can discuss your options and recommend opportunities that may be suitable for you. Call 813-745-6100 or 1-800-679-0775 (toll-free) or submit a clinical trials inquiry form.
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