Preliminary treatment, peripheral T cell lymphoma with follicular assisted T cell phenotype
Conditions
Interventions
Control group:Chidamide Simulation film Tablets
Test group:Chidamide Tablets
Sponsors
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Understand and voluntarily sign the written informed consent form (ICF). 2. Age >=18 years old and 1.5 cm in diameter, and non-lymph node lesions, measurable extranodal lesions need to be > 1.0 cm in diameter. 6. At screening, laboratory tests meet the following criteria, unless the investigator can judge that it is caused by lymphoma (correction and supportive treatment of the following parameters has not been performed within 2 weeks before evaluation): 1) Routine blood tests: hemoglobin (Hb) >=90g/L, absolute neutrophil value (ANC) >=1.5×109/L, platelet count (PLT) >=90×109/L. 2) Biochemical examination: serum creatinine (Cr) <=1.5× upper limit of normal value (ULN); Serum total bilirubin (TBIL) <=1.5×ULN; Alanine aminotransferase (ALT) and 2) aspartate aminotransferase (AST) <=2.5× ULN (liver metastasis cases: =5× ULN). 7. Life expectancy of at least 6 months, as judged by the investigator.
Exclusion criteria
Exclusion criteria: 1. Accompanied by central nervous system metastasis or leptomeningeal metastasis. 2. Previous treatment for lymphoma, including chemotherapy, targeted therapy, immunotherapy, local radiotherapy (except for local radiotherapy to relieve tumor-related symptoms), surgical treatment (except tumor or pathological tissue biopsy and surgical resection not for lymphoma). 3. Patients who plan to undergo trial treatment after obtaining CR or are judged by the investigator to be suitable for hematopoietic stem cell transplantation consolidation therapy. 4. History of other malignant tumors within 5 years before the first dose, except for cured local tumors, such as basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, carcinoma in situ of the cervix, carcinoma in situ of the breast, localized prostate cancer, micropapillary carcinoma of the thyroid, etc. 5. Received cytotoxic drugs for other diseases (e.g., rheumatoid arthritis) within 5 years before the first dose. 6. Participated in other interventional clinical trials within 3 months before the first dose. 7. Contraindications to any CHOP component. 8. Glucocorticoid medication >30 mg/day prednisone or equivalent for other purposes other than lymphoma symptom control; The following circumstances are permitted for enrollment: 1) If receiving corticosteroid therapy, i.e., = 30 mg/day prednisone or equivalent, must have documented evidence of stable medication use for at least 4 weeks prior to the start of treatment cycle 1; 2) If glucocorticoid therapy is urgently needed to control lymphoma symptoms before the first dose, treatment can be done with doprednisone 100 mg/day or equivalent for up to 7 days, but all tumor assessments must be completed before the start of glucocorticoid therapy. 9. Severe peripheral or central nervous system disease, such as a history of progressive multifocal leukoencephalus. 10. Has uncontrolled or significant cardiovascular disease, including: 1) New York Heart Association (NYHA) Class II. or above congestive heart failure, unstable angina, myocardial infarction within 6 months prior to the first administration of study drug, or presence of arrhythmias requiring treatment, left ventricular ejection fraction (LVEF) at screening 470 ms (females) and > 450 ms (males) during the screening period; 4) Coronary heart disease with symptoms requiring medication during the screening period; 5) Other cardiovascular diseases judged by the investigator to be unsuitable for enrollment. 11. Patients with suspected interstitial lung disease (ILD) or pulmonary fibrosis or pneumonia requiring treatment (including infectious or non-infectious) with old or patchy changes after previous treatment can be enrolled in chest imaging during the screening period, as judged by the investigator to not affect lung function and do not require treatment. 12. Obvious gastrointestinal abnormalities during the screening period, which may affect the intake, transport or absorption of drugs (such as inability to swallow, chronic diarrhea, post-small bowel resection or total gastrectomy, etc.) in the judgment of the investigator. 13. History of deep vein thrombosis, arterial throm
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS; | — |
Countries
China
Contacts
Public ContactMei Heng
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Outcome results
None listed