Peripheral T cell lymphoma, non-specific type Intracnodal follicle-assisted T-cell lymphoma, vascular immunoparent type Intracnodal follicle-assisted T-cell lymphoma, follicular type Intranodal follicle-assisted T-cell lymphoma, non-specific type Anaplastic large cell lymphoma, ALK(-) Anaplastic large cell lymphoma, ALK(+) Enteropathy-associated T-cell lymphoma Monomorphic epitheliophilic i
Conditions
Interventions
PhaseII:XNW5004 tablets
Sponsors
hunan cancer hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Age 18 to 70 years old (including 18 and 70 years old) No gender limitation; 2. Pathologically confirmed, relapsed, or refractory peripheral T-cell lymphoma (see Appendix 9); 3. Relapse is difficult to treat after receiving two kinds of systemic therapy in the past, including at least one new drug (sidarbenamine, pratoxa, vibutuximab, etc.); CD30+ ALCL must have been previously treated with vibutuximab; Relapse and refractory are defined as follows: Relapse refers to disease progression after the subject has received adequate treatment in the past to achieve remission (including complete and partial remission), including remission for 1-3 years, and is not suitable for or does not receive autologous hematopoietic stem cell transplantation rescue therapy; Refractory: Subjects did not achieve remission with prior two-line therapy, or disease progression during prior two-line therapy/within 1 year after completion of adequate therapy, including: (1) failure to achieve stable disease (SD) after =2 cycles of the last treatment course according to clinically recommended standards or conventional protocols, or failure to achieve partial remission (PR) after =4 cycles of the last treatment course; (2) If the best effect or cause of termination is disease progression (PD), the number of courses is not required; (3) Patients with recurrence after autologous hematopoietic stem cell transplantation; 4. Subjects who had previously received radiotherapy were admitted, but radiotherapy alone was not considered a systemic treatment; 5. At least one measurable lesion should be present as the basis for evaluation: the length of the lesion should be > 1.5cm; The size of the extranodal lesion should be > 1.0cm, and the lesion should be FDG-PET positive. 6. Agree to provide archived tumor tissue samples or fresh tumor tissue samples that meet the requirements; 7. Life expectancy of at least 12 weeks; 8. ECOG physical strength score is 0-1; 9. Vital organ functional reserve meets the following requirements: 1) hematopoietic function: a) absolute neutrophil count (ANC) =1.5×109/L (=1.0×109/L for patients with bone marrow infiltration) (G-CSF was not used within 1 week before blood routine examination during screening, and long-acting ascending white needle was not used within 2 weeks); b) Platelet count =100×109/L (=75×109/L for patients with bone marrow infiltration) (no platelet transfusion or TPO receptor agonist was used within 1 week before blood routine examination during the screening period); c) Hemoglobin =100 g/L (=80 g/L for patients with bone marrow infiltration) (no red blood cells were transfused and no EPO was used within 1 week before blood routine examination during screening period); 2) Liver function: serum total bilirubin =1.5×ULN (Gilbert's syndrome =3 ULN), alanine aminotransferase (ALT) and glutamic oxal aminotransferase (AST) =2.5×ULN, ALT/AST=5×ULN in subjects with liver invasion, alkaline phosphatase =5×ULN in subjects with liver and/or bone invasion; 3) Kidney function: serum creatinine =1.5×ULN or creatinine clearance =60 mL/min as estimated by Cockcroft-Gault formula (see Appendix 3 for details); 4) Left ventricular ejection fraction (LVEF) =50%; 5) International Standardized ratio (INR) =1.5×ULN or plasma prothrombin time (PT) =1.5×ULN, partial thromboplastin time (APTT) =1.5×ULN. 10. Women of reproductive age must have a negative serum pregnancy test before entering the study and consent to complete contraception for
Exclusion criteria
Exclusion criteria: 1. Prior treatment with EZH2 inhibitors or EZH1/2 inhibitors or drugs with a pathway similar to or related to the investigational drug (including but not limited to Tazemetostat); 2. Subjects who are known to be allergic to the test drug or its active ingredients or excipients; 3. Have used chemotherapy, immunotherapy, radiotherapy, targeted therapy, anti-tumor Chinese medicine and other anti-tumor therapies within 4 weeks before the first dose or within 5 half-lives (whichever is shorter); 4. Received anti-tumor experimental drugs within 28 days before the first administration of this trial; 5. Subjects who had major surgery within 4 weeks prior to the start of study treatment or planned to have major surgery during the study period (except for procedures such as puncture or lymph node biopsy); 6. Previously received allogeneic hematopoietic stem cell transplantation or solid organ transplantation; 7. Diseases requiring systemic treatment with corticosteroids (> 10 mg of prednisone per day or equivalent doses of other glucocorticoids) or other immunosuppressive agents during the 14 days prior to the administration of the test drug. In the absence of active autoimmune disease, inhaled or topical steroids and adrenal replacement therapy with a daily dose of prednisone = 10 mg or equivalent doses of other glucocorticoids are permitted; 8. Subjects taking known moderate or strong CYP3A4 inhibitors/inducers within 14 days prior to initial dosing (see Appendix 5 for details); 9. Receive live virus vaccine (including live attenuated vaccine) within 28 days prior to administration. Inactivated vaccines are allowed; 10. People with a history of psychotropic drug abuse or drug abuse; 11. Patients who have received antitumor therapy in the previous period and toxicity has not recovered (toxicity has not recovered to = grade 1 according to NCI-CTCAE 5.0). Other toxicities (such as alopecia, etc.) that the investigator believes do not affect the safety evaluation of the subject are excluded; 12. Had a history of other malignant tumors within 3 years prior to enrollment and did not meet clinical cure criteria. Exceptions include: basal cell or squamous cell carcinoma of the skin, superficial bladder cancer, carcinoma in situ of the cervix, intraductal carcinoma in situ of the breast and papillary carcinoma of the thyroid, which can be treated locally and has been cured; 13. Mycosis fungoides, Sezary syndrome and primary cutaneous T-cell lymphoma; 14. Past or current central nervous system aggression; 15. Past or current testicular or breast invasion; 16. Past or current hemophagocytic syndrome; 17. Previous or current patients with immune thrombocytopenia, autoimmune hemolytic anemia, aplastic anemia and other primary or secondary hematological diseases that may affect bone marrow function in addition to primary malignancies; 18. Past or current acute myeloid leukemia (AML); 19. Previous or current T-cell lymphoblastic lymphoma (T-LBL) or T-cell lymphoblastic leukemia (T-ALL); 20. Have a history of any myeloid malignancy, including myelodysplastic syndrome (MDS), or abnormal test indicators associated with MDS or myeloproliferative tumor (MPN); 21. Previous patients with or accompanied by central nervous system diseases, including but not limited to epilepsy, paralysis, stroke, severe brain injury, senile dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, mental illness, etc.; 22. Impaired cardiac functio
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| objective response rate ; | — |
Secondary
| Measure | Time frame |
|---|---|
| disease control rate;duration of tumor response;progression-free survival;time to disease response; | — |
Countries
China
Contacts
Public ContactHui Zhou
hunan cancer hospital
Outcome results
None listed