Copanlisib and Gemcitabine in Relapsed/Refractory PTCL

Inclusion Criteria: * Histologically confirmed relapsed or refractory PTCL or NK/T-cell lymphomas, excluding primary cutaneous T-cell lymphoma, and Sezary syndrome based on WHO classification, * Age ≥ 19 * ECOG performance status ≤ 2 * at least one bi-dimensional measurable lesion * Laboratory values * Serum Cr \< 1.5 mg/dL or CrCl \> 50 mL/min * Transaminase (AST/ALT) \< 2.5 x ULN (or \< 5 x ULN in the presence of lymphoma involvement of the liver) * Bilirubin \< 1.5 x UNL ( or \< 3 x ULN in the presence of lymphoma involvement of the liver or Gilbert syndrome) * PT (INR) ≤ 1.5 x ULN and aPTT ≤ 1.5 x ULN * Lipase ≤ 1.5 x ULN * Hematologic functions: absolute neutrophil count (ANC) ≥ 1,500/µL and platelet count ≥ 75,000/µL, hemoglobin ≥ 8 g/dL * Left ventricular ejection fraction (LVEF) ≥ the lower limit of normal for the institution * Women of childbearing potential and men must agree to use adequate contraception when sexually active * Written informed consent Exclusion Criteria: * B-cell NHL, or primary cutaneous T-cell lymphoma and Sezary syndrome * Patients who had previous history of lymphoma involvement of the CNS. * History of previous gemcitabine therapy * Type I or II diabetes mellitus with HbA1c \> 8.5% at screening * History of chronic hepatitis B; subjects positive for HBsAg will be excluded from this study. However, subjects with HBcAb will be eligible if they are negative for HBV DNA quantification * History of chronic hepatitis C; subjects positive for HCV IgG will be eligible if they are negative for HCV-RNA quantification * Known history of human immunodeficiency virus (HIV) infection * History or concurrent condition of interstitial lung disease of any severity and/or severely impaired lung function * Any other malignancies within the past 3 years except curatively treated basal cell carcinoma of the skin, carcinoma in situ of the uterine cervix, or papillary carcinoma of the thyroid * Other serious illness or medical conditions * Congestive heart failure \> NYHA class 2 (Appendix III) * Unstable angina or new-onset angina within the last 3 months; Myocardial infarction within 6 months prior to study entry * History of significant neurological or psychiatric disorders including dementia or seizure * Uncontrolled hypertension despite optimal medical management (per investigator's opinion) * Arterial or venous thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis or pulmonary embolism within 6 months before start of study treatment * Non-healing wound, ulcer, or bone fracture * Active uncontrolled infection (viral, bacterial, or fungal infection) * Patients with evidence or history of bleeding diathesis. Any hemorrhage or bleeding event ≥ grade 3 within 4 weeks of start of study medication * Proteinuria estimated by urine protein/creatinine ratio \> 3.5 on a random urine sample * Concurrent diagnosis of pheochromocytoma * Other previous or concurrent treatments * Ongoing immunosuppressive therapy * Radiotherapy or immune-/chemotherapy less than 4 weeks before start of treatment * Radioimmunotherapy or autologous transplant less than 3 months before start of treatment * Myeloid growth factors within 14 days prior to treatment start * Blood or platelet transfusion within 7 days prior to treatment start * Systemic continuous corticosteroid therapy at a daily dose higher than 15 mg prednisone or equivalent * History of having received an allogeneic bone marrow or organ transplant * Major surgical procedure or significant trauma injury within 28 days before start of study medication, open biopsy within 7 days before start of study treatment * Anti-arrhythmic therapy (beta-blockers or digoxin are permitted) * Use of CYP3A4 inhibitor or inducer * Pregnant or lactating women, women of childbearing potential not employing adequate contraception * Concomitant administration of any other experimental drugs under investigation