A Phase IIa Clinical Study of Purinostat Mesylate for Injection in Patients With Peripheral T-Cell Lymphoma and Cutaneous T-Cell Lymphoma

Exclusion criteria

• . Patients with leukemic PTCL (e.g., adult T-cell leukemia/lymphoma, etc.), or lymphomatous leukemia stage (percentage of lymphoma cells ≥20% on bone marrow examination), or central nervous system (CNS) involvement, or concomitant hemophagocytic syndrome;
• . Have a history of allergy to similar drugs and excipients of the test drug;
• . Have received any other antitumor therapy \[including chemotherapy with cytotoxic agents, molecularly targeted therapy, immunotherapy, or other biological therapies within 4 weeks prior to the first use of the test drug, mitomycin or nitrosamines within 6 weeks, small molecule targeted agents at least 2 weeks or at least 5 half-life intervals from the last dose, whichever is longer, and traditional Chinese medicines with antitumor indications at least 2 weeks from the last dose\], and have received the test drug within 4 weeks prior to the first use of the test drug, or have a history of hypersensitivity to similar drugs and excipient components of the test drug; or have a history of allergy to the test drug. Chinese herbal medicines with antitumor indications should be administered at least 2 weeks after the last dose\], and local radiotherapy within 4 weeks prior to the first administration of the test drug;
• . The presence of persistent Grade 2 or above (CTCAE V5.0 standard) toxicity reaction after the previous treatment (chemotherapy or biotherapy or targeted therapy, etc.), which has not yet recovered to Grade ≤1 level at the time of enrollment (with the exception of alopecia areata);
• . Vaccination with live attenuated vaccine within 28 days prior to the first dose of study drug or within 60 days of the end of treatment with study drug;
• . Have received a blood transfusion, recombinant human thrombopoietin, erythropoietin, or granulocyte colony-stimulating factor within 2 weeks prior to the first dose of the investigational drug;
• . A history of solid organ or allogeneic hematopoietic stem cell transplantation; autologous hematopoietic stem cell transplantation within 3 months prior to the first dose of the investigational drug;
• . Patients who have received any of the following treatments within 7 days prior to the first dose of the investigational drug: drugs known to be potent inhibitors/inducers of CYP 3A4, drugs known to significantly prolong the QT period;