peripheral T-cell lymphoma
Conditions
Interventions
Young Group:chidamide + azacytidine + CHOP
Elderly group:chidamide + azacytidine + lenalidomide
Sponsors
Jiangsu Provincial People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Angioimmunoblastic T-cell lymphoma (AITL) or peripheral T-cell lymphoma (PTCL) with follicular helper T-cell phenotype (TFH) newly diagnosed by histopathology; 2. There is an evaluable lesion, defined as the long diameter of the lesion >=15 mm or the vertical diameter of the long diameter >=10 mm, or the lesion has uptake on the 18FDG-PET scan; 3. According to the Eastern Cooperative Oncology Group Performance Status (Eastern Cooperative Oncology Group Performance Status, hereinafter referred to as ECOG PS score) is 0-4; 4. Sign the written informed consent, and be able to abide by the visits and related procedures specified in the plan; 5.18 years old = 12 weeks; 7. Female subjects of childbearing age or male subjects whose sexual partners are females of childbearing age should take effective contraceptive measures throughout the treatment period and within 90 days after the last treatment; 8. Having adequate organ and bone marrow function, as defined below: (1) Blood routine: absolute neutrophil count (ANC) >= 1.0x10^9/L, platelet count (PLT) >= 50x10^9/L, hemoglobin (HGB) ) >= 7.0 g/dL; (2) Liver function: serum total bilirubin (TBIL) <= 2 x upper limit of normal value (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase Transferase (aspartate transferase, AST)<=3xULN; (3) Renal function: serum creatinine (Cr) <= 2xULN.
Exclusion criteria
Exclusion criteria: 1. Patients with severe hemophagocytic syndrome; 2. Patients with lesions invading large blood vessels in the lungs; 3. Previous exposure to HDAC inhibitors, demethylation drugs, lenalidomide or CHOP regimen and showed drug resistance; 4. Participate in another interventional clinical study at the same time, unless participating in an observational (non-interventional) clinical study or in the follow-up phase of an interventional study; 5. Received any investigational drug within 4 weeks before the first dose of study treatment; 6. Receive the last dose of radiotherapy or the last dose of anti-tumor therapy (chemotherapy, targeted therapy or tumor embolization, etc.) within 3 weeks before the first dose of study treatment; receive the last dose of subcutaneous therapy within 6 weeks before the first dose of study treatment Nitrourea or mitomycin C therapy; 7. The use of immunosuppressive drugs within 4 weeks before the first dose of study treatment, excluding local glucocorticoids or physiological doses of systemic glucocorticoids by nasal spray, inhalation or other routes (ie not more than 10 mg/day) prednisone or equivalent doses of other glucocorticoids); 8. Within 4 weeks before the first dose of study treatment or planning to receive live attenuated vaccine during the study; 9. Received major surgical operations (craniotomy, thoracotomy or laparotomy) or unhealed wounds, ulcers or fractures within 4 weeks before the first dose of study treatment; 10. Active, known or suspected autoimmune disease or history of the disease within the past 2 years (Vitiligo, psoriasis, alopecia or Grave's disease not requiring systemic treatment within the past 2 years, only thyroid Hypothyroidism on hormone replacement therapy and type 1 diabetes patients requiring only insulin replacement therapy can be enrolled); 11. Known history of primary immunodeficiency; 12. Known to have active pulmonary tuberculosis; 13. Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation; 14. Uncontrolled concurrent diseases include but are not limited to: (1) HIV-infected persons (HIV antibody positive); (2) Serious infection in active stage or poorly controlled clinically; (3) Symptomatic congestive heart failure (New York Heart Association class III-IV) or symptomatic or poorly controlled arrhythmia; (4) Uncontrolled arterial hypertension (systolic blood pressure >= 160 mmHg or diastolic blood pressure >= 100 mmHg) despite standard treatment; (5) Any arterial thromboembolic events, including myocardial infarction, unstable angina pectoris, cerebrovascular accident or transient cerebral ischemic attack, have occurred within 6 months prior to the selected treatment; (6) Any life-threatening bleeding event or grade 3 or 4 gastrointestinal/variceal bleeding event requiring blood transfusion, endoscopic or surgical treatment within 3 months prior to inclusion in the study; (7) A history of deep vein thrombosis, pulmonary embolism, or any other serious thromboembolism (implantable venous port or catheter-derived thrombosis, or superficial vein thrombosis) within 3 months prior to enrollment is not considered severe thromboembolism); (8) Uncontrolled metabolic disorders or other non-malignant organ or systemic diseases or secondary reactions of cancer, which can lead to higher medical risk and/or uncertainty in survival evaluation; (9) Hepatic encephalopathy, hepatorenal syndrome or Child-Pugh grade B or
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Best overall response rate;1-year progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| complete remission rate;partial response rate;overall survival; | — |
Countries
China
Contacts
Public ContactFan Lei
Jiangsu Provincial People's Hospital
Outcome results
None listed