peripheral T-cell lymphoma
Conditions
Interventions
experimental group:arotinib hydrochloride capsule
Sponsors
Jiangsu Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. 18-75 years old, ECoG score 0-2, estimated survival time more than 6 months; 2. Peripheral T-cell lymphoma (PTCL) (including non-specific peripheral T-cell lymphoma, angioimmunoblastic T-cell lymphoma (AITL), anaplastic large cell lymphoma (ALCL), enteropathy related T-cell lymphoma (EATL), monomorphic epithelial T-cell lymphoma (meitl), intranodal and extranodal Peripheral T-cell lymphoma (PTCL, TFH), follicular T-cell lymphoma (FTCL), NK / T-cell lymphoma, primary cutaneous T-cell lymphoma and unclassified peripheral T-cell lymphoma); 3. Subjects who have previously received at least one systemic treatment failure or relapse after treatment remission; 4. There is at least one measurable lesion in any Ann Arbor stage (I-IV). For intranodal lesions, it is defined as: long diameter = 1.5cm and short diameter = 1.0cm; for extranodal lesions, long diameter = 1.0cm; 5. The main organ functions meet the following standards within 7 days before treatment: (1) Blood routine examination standard: ? Hemoglobin (HB) = 90g / L (no blood transfusion within 14 days); ? Neu = 1.5 × 109 / L; ? Platelet (PLT) = 100 × 109/L. (2) Blood biochemical examination standard: ? TBIL = 1.5 × ULN (Gilbert syndrome, < 3 × ULN); ? Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) were less than or equal to 2.5 × ULN; ? Serum creatinine (CR) < 1.5 × ULN or creatinine clearance rate (CCR) = 50ml / min; (3) Doppler ultrasound evaluation: left ventricular ejection fraction (LVEF) = the lower limit of normal value (50%). 6. Women of childbearing age should agree to use contraceptive measures (such as IUD, contraceptive pill or condom) during the study period and within 6 months after the end of the study; the serum or urine pregnancy test is negative within 7 days before the study group, and it must be non lactation period; men should agree to use contraceptive measures during the study period and within 6 months after the end of the study period; 7. Volunteered to join the study and signed the informed consent form, with good compliance.
Exclusion criteria
Exclusion criteria: Any of the following subjects will not be included in this study: 1. Previously, we received targeted drug therapy of vascular endothelial growth inhibitors, such as sunitinib, sorafenib, pazopanil, imatinib, famitinib, apatinib, and arotinib; 2. Metastasis of central nervous system or meningeal invasion; 3. In 5 years, there have been or are currently suffering from other malignant tumors, except for the cured carcinoma in situ of cervix, skin cancer of non melanoma and superficial bladder tumor [ta (non invasive tumor), tis (in situ cancer) and T1 (tumor infiltrating basement membrane)]; 4. Previous bone marrow transplantation or organ transplantation; 5. Those with multiple factors (such as inability to swallow, chronic diarrhea and intestinal obstruction) affecting oral drugs; 6. Have uncontrollable or important cardiovascular diseases, including: a) History of myocardial infarction; b) In the first 6 months of the screening period, the patients had uncontrolled angina pectoris, or now they need to take anti angina drugs; c) There was a history of congestive heart failure; d) Any clinically significant history of ventricular arrhythmia (such as ventricular tachycardia, ventricular fibrillation or torsade de pointes); e) History of supraventricular and nodal arrhythmias that cannot be controlled by pacemakers or drugs; f) History of myocardial disease; g) The clinical significance of QTc interval prolongation history, or screening period QTc interval > 450 ms; h) Coronary heart disease with symptoms requiring medication. 7. There are any serious and / or uncontrollable diseases, including: a) Blood pressure control was not ideal (systolic pressure = 150 mmHg, diastolic pressure = 90 mmHg); b) Active or uncontrollable severe infection (= CTC AE Level 2 infection), or continuous fever within 14 days before screening period; c) Liver cirrhosis, decompensated liver disease, active hepatitis * or chronic hepatitis should be treated with antiviral therapy; *Active hepatitis (HBV reference: HBsAg positive, and HBV DNA detection value exceeds the upper limit of normal value; HCV reference: HCV antibody positive); d) HIV positive, Treponema pallidum antibody positive; e) Poor control of diabetes mellitus (fasting blood glucose = CTCAE Level 2); f) Routine urine test indicated that urine protein was = + +, and 24-hour urine protein was more than 1.0 G. 8. Received major surgical treatment, open biopsy or obvious traumatic injury within 28 days before the first application; 9. Being treated with systemic glucocorticoid or any other form of immunosuppressive therapy (dose > 10mg / day prednisone or other therapeutic hormones), and still in use within 2 weeks after the first application; 10. The imaging shows that the tumor has invaded the important blood vessels or the tumor is likely to invade the important blood vessels and cause fatal bleeding during the follow-up study; 11. No matter the severity, there are any physical signs or history of bleeding; within 4 weeks before the first application, there are any bleeding or bleeding events = CTC AE 3, and there are unhealed wounds, ulcers or fractures; 12. In 6 months, there have been events of arteriovenous thrombosis, such as cerebrovascular accident (including temporary ischemic attack), deep vein thrombosis and pulmonary embolism; 13. Those who have a history of abuse of psychotropic substances and are unable
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| PFS;OS;DOR; | — |
Countries
CHINA
Contacts
Public ContactFENG JIFENG
Outcome results
None listed