Duvelisib and Venetoclax in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma (PTCL)

Inclusion Criteria: * Phase I: Histologically confirmed relapsed/refractory PTCL, except the following lymphoma subtypes: cutaneous T-cell lymphoma (CTCL) and T-cell-prolymphocytic leukemia (TPLL). * Phase II: same as phase I * Disease that has progressed during or relapsed after at least two previous therapies. * ECOG performance status ≤ 2 * Adequate hepatic function defined as: o Serum aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 3.0 x upper limit of normal (ULN), bilirubin ≤ 1.5 x ULN (unless bilirubin rise is due to Gilbert's syndrome or of non-hepatic origin * Adequate renal function as defined by: o Creatinine clearance ≥ 30 mL/min; calculated by the Cockcroft Gault formula or measured by 24 hours urine collection * Patients must meet the following hematologic criteria at screening, unless they have significant bone marrow involvement confirmed on biopsy: * Absolute neutrophil count ≥ 1500 cells/mm3 (1.5 x 109/L) or ≥ 1000 cells/mm3 (1.5 x 109/L) with bone marrow involvement. Growth factor use is allowed in order to achieve this * Platelet count ≥ 50,000 cells/mm3 (50 x 109/L) independent of transfusion within 7 days of screening * Hemoglobin ≥8 g/dL (without transfusion support.) Exclusion Criteria: * Phase I and Phase II: * Patients eligible for Hematopoietic stem cell transplantation (HSCT) * Cutaneous T-cell lymphoma (CTCL) and T-cell-prolymphocytic leukemia (TPLL) * Suspected and confirmed central nervous system involvement …