PTCL
Conditions
Interventions
Group 1 :selinexor + CHOP
Sponsors
Jiangsu Province Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. According the 2016 revision of the World Health Organization classification of lymphoid neoplasms, peripheral T-cell lymphoma (PTCL) (including peripheral T-cell lymphoma non-specific type (PTCL-NOS), vascular immunoblastic T-cell lymphoma (AITL), anaplastic large cell lymphoma (ALCL)) was confirmed by histopathology; 2. With measurable lesions (at least one lymph node target, defined as the longest diameter > 1.5 cm and clearly measurable in both vertical directions); 3. Age >= 18 years, = 80 g/L; absolute neutrophil count (ANC) >= 1.5 x 10^9/L; platelet count (PLT) >= 75 x 10^9/L; (2) Liver function: serum total bilirubin (TBIL) = 50 mL/min; (4) Coagulation function: International standardized ratio (INR) and prothrombin time (PT) <= 1.5 x ULN; 9. Sign the written informed consent, and be able to abide by the visits and related procedures specified in the plan.
Exclusion criteria
Exclusion criteria: 1. Patients who are allergic to, resistant to, or intolerant to clincal treated drugs determined by the investigator; 2. Patients who received any investigational drug or radiotherapy within 4 weeks; 3. Patients who have undergone major surgery within 4 weeks; 4. Patients with severe infection within 4 weeks who were not suitable for chemotherapy judged by researchers; 5. Patients with history of stroke or intracranial hemorrhage within 3 months; or patients with grade 3 or more active gastrointestinal bleeding; 6. Femal patients with pregnancy or lactation; 7. Impaired heart function or significant heart disease, including but not limited to: (1) Experienced myocardial infarction, congestive heart failure, or viral cardiomyositis within 6 months prior to screening; (2) Heart disease with symptoms requiring therapeutic intervention, such as unstable angina pectoris and arrhythmia; (3) Cardiac function grades II-IV (NYHA, New York College of Cardiology); (4) Cardiac ejection fraction (EF) detected by echocardiography was lower than 50% or the lower limit of the study center; 8. Patients with a known history of human immunodeficiency virus (HIV) infection, or a history of primary immunodeficiency, or active tuberculosis; 9. Patients with poorly controlled hypertension and diabetes; 10. Patients with active hepatitis B or C infection (for HBsAg positive or HBcAb positive subjects, if no hepatitis B virus (HBV)-DNA is detected, can be enrolled; for HCV antibody positive subjects, if no HCV-RNA can be detected, they can be enrolled); 11. Patients with history of malignant tumor that may affect the implementation of the trial protocol or the analysis of the results (except cured basal cell carcinoma of the skin, carcinoma in situ of the cervix, carcinoma in situ of the breast, intramucosal carcinoma of the gastrointestinal tract in situ, and localized prostate cancer); 12. Patients with active mental illness, alcohol, drug or substance abuse; 13. Patients who were unsuitable for the study judged by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| overall response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| complete remission rate;duration of remission;1-year progression-free survival;1 year overall survival;safety; | — |
Countries
China
Contacts
Public ContactFan Lei
Jiangsu Province Hospital
Outcome results
None listed