Extranodal natural killer cell/T-cell lymphoma
Conditions
Interventions
Case series:Sintilimab,Chidamide
Sponsors
Sun Yat-sen University Cancer Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Volunteer to participate in clinical research; fully understand and know the research and sign the Informed Consent Form (ICF); willing to follow and have the ability to complete all trial procedures; 2. Aged 18-75 years old male or female; 3. Extranodal NK/T-cell lymphoma confirmed by histopathology examination; 4. Paraffin tissue specimens or fresh puncture tissue specimens are available; 5. Patients with disease progression or non-remission after asparaginase treatment or asparaginase-contained regimen treatment. Non-remission is defined as: patients did not get partial remission (PR) or better responses after treated by L-asparaginase contained regimen; 6. ECOG: 0-1; 7. Estimated survival = 3 months; 8. There must be at least one evaluate able or measurable lesion that meets the RECIL 2017 Lymphoma criteria [evaluable lesion: 18F-fluorodeoxyglucose/Positron Emission Tomography (18FDG/PET) examination showing increased lymph node or extranodal uptake (higher than liver) and PET and/or computed tomography (Computed Tomography) CT) features are consistent with lymphoma findings; lesions can be measured: nodular lesions > 15mm or extranodal lesions > 10mm (if the only measurable lesion has received radiotherapy in the past, there must be evidence of radiological progress after radiotherapy), and accompanied by increased 18FDG uptake). Except for this, there is no measurable increase in diffuse 18FDG uptake in the liver; 9. Adequate organ and bone marrow function, no severe hematopoietic dysfunction, cardiac, pulmonary, liver, kidney, thyroid dysfunction and immune deficiency (no blood transfusion, granulocyte colony stimulating factor or other medical support was received within 14 days prior to the use of the research drug): 1) The absolute value of neutrophils (>1.0×10^9/L); 2) platelet count (> 75×10^9/L); 3) Hemoglobin (> 9 g/dL); 4) Upper Limit Normal (ULN) or creatinine clearance rate (>40 mL/min) of serum creatinine (<1.5 times normal value upper limit) (estimated by Cockcroft-Gault formula); 5) Serum total bilirubin < 1.5 times ULN; 6) Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) = 2.5 times ULN; 7) Coagulation function: International Normalized Ratio (INR) = 1.5 times ULN; Prothrombin Time (PT), Activated Partial Thromboplastin Time (APTT) = 1.5 times ULN (unless the subject is receiving anticoagulant therapy and PT and APTT are using anticoagulant therapy at screening time). Within the expected range; 8) Thyrotropin (TSH) or free thyroxine (FT4) or free triiodothyronine (FT3) were all within the normal range (+10%); 10. There was no evidence that subjects had difficulty breathing at rest, and the measured value of pulse oximetry at rest was more than 92%; 11. Participants must pass a pulmonary function test (PFT) to confirm that forced expiratory volume (FEV1)/forced vital capacity (FVC) in the first second is more than 60%, unless it is a large mediastinal mass caused by lymphoma that cannot meet this standard; carbon monoxide diffusion (DLCO), FEV1 and FVC are all above 50% of the predicted value; all PFT results must be obtained within four weeks before the first administration; 12. Subjects who have received antineoplastic therapy should be admitted to the group only after the toxicity of the previous treatment has returned to the level of Common Terminology Criteria for Adverse Events (CTCAE) V5.0 grade score < 1 or baseline level; the level 2 toxicity caused by previous antineopl
Exclusion criteria
Exclusion criteria: 1. Invasive natural killer cell leukemia; 2. Hemophagocytic syndrome; 3. Primary central nervous system lymphoma or secondary central nervous system involvement; 4. Received organ transplantation in the past; 5. Patients who received allogeneic hematopoietic stem cell transplantation within three years before the drug was given (patients who received allogeneic hematopoietic stem cell transplantation more than three years before the drug was given and who currently have no graft-versus-host response can be enrolled); 6. Participating in other clinical studies or planning to start this study is less than 4 weeks from the end of the previous clinical study; 7. Autologous hematopoietic stem cell transplantation was performed within 90 days before the start of the study; 8. Previous treatment with immunologic checkpoint inhibitors (PD-1, PD-L1, CTLA-4, etc.); 9. The drug was treated with histone deacetylase inhibitors within one year before administration; 10. Patients with active autoimmune diseases requiring systematic treatment in the past two years (hormone replacement therapy is not considered systematic treatment, such as type I diabetes mellitus, hypothyroidism requiring only thyroxine replacement therapy, adrenocortical dysfunction or pituitary dysfunction requiring only physiological doses of glucocorticoid replacement therapy); Patients with autoimmune diseases who do not require systematic treatment within two years can be enrolled; 11. Begin the study on subjects requiring systemic glucocorticoid therapy or other immunosuppressive therapy for a given condition within 14 days before treatment [allowing subjects to use local, ocular, intra-articular, intranasal and inhaled glucocorticoid therapy (with very low systemic absorption); and allowing short-term (< 7 days) glucocorticoid prophylaxis (e.g., contrast agent overdose) Sensitivity) or for the treatment of non-autoimmune diseases (e.g. delayed hypersensitivity caused by contact allergens); 12. In the past five years, patients with other malignant tumors have undergone radical treatment, except for basal cell carcinoma of skin, squamous cell carcinoma of skin, carcinoma in situ of breast and carcinoma in situ of cervix. 13. Begin the study and receive systemic antineoplastic therapy within 28 days before treatment, including chemotherapy, immunotherapy, biotherapy (cancer vaccine, cytokines, or growth factors that control cancer), etc.; 14. The study began with major surgery within 28 days before treatment or radiotherapy within 90 days before treatment; 15. Start the study and receive Chinese herbal medicine or Chinese patent medicine treatment within 7 days before treatment; 16. Begin research on live vaccination (except influenza attenuated vaccine) within 28 days before treatment; 17. History of human immunodeficiency virus (HIV) infection and/or patients with acquired immunodeficiency syndrome are known; 18. Patients with active hepatitis B or active hepatitis C. Patients who are positive for hepatitis B Surface Antigen (HBsAg) or hepatitis C Virus (HCV) antibodies at screening stage must pass further detection of hepatitis B Virus (HBV) DNA titer (no more than 2500 copies/mL or 500 IU/mL) and HCV RNA (no more than the lower limit of the detection method) in the row. In addition to active hepatitis B or hepatitis C infections requiring treatment, group trials can be conducted. Hepatitis B carriers, stable hepatitis B (DNA titer should not be higher than 25
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate;maximum tolerated dose of chidmide;dose-limiting toxicities of chidamide;recommended phase II dose of chidamide; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression Free Survival;Duration of Response;Overall survival;EB virus activation;Adverse Event;biomarkers; | — |
Countries
China
Contacts
Public ContactHui-qiang Huang
Sun Yat-sen University Cancer Center
Outcome results
None listed