Angioimmunoblastic T-cell lymphoma
Conditions
Interventions
Single arm:Mitoxantrone liposome, Azacitidine and Chidamide
Sponsors
Shanxi Cancer Hospital/Cancer Hospital of the Chinese Academy of Medical Sciences, Shanxi Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. The patient fully understands this study and voluntarily participates; 2. Age: = 18 years old; 3. Expected survival time = 3 months; 4. Angioimmunoblastic T-cell lymphoma (AITL) confirmed by histopathology; 5.Recurrent and refractory patients who have been diagnosed for the first time or have received at least first-line anthracycline containing systematic Sex therapy in the past. Recurrence and refractory treatment are defined as recurrence after CR or failure to achieve partial remission in the first chemotherapy cycle 2, and failure to achieve complete remission in the first chemotherapy cycle 6 6. There must be at least one evaluable or measurable lesion that meets the Lugano2014 standard: a lymph node lesion, with a measurable lymph node length greater than 1.5cm in diameter; Non lymph node lesions, measurable extranodal lesions with a length diameter greater than 1.0cm; 7. ECOG score 0-2 points; 8. Liver and kidney function: Serum creatinine = 1.5 times the upper limit of normal value; AST and ALT = 2.5 times the upper limit of normal values (= 5 times the upper limit of normal values for patients with liver invasion); Total bilirubin = 1.5 times the upper limit of normal value (= 3 times the upper limit of normal value for patients with liver invasion);
Exclusion criteria
Exclusion criteria: 1. Uncontrollable systemic diseases, that is, those still not up to the standard after drug treatment, are still higher than the normal indicators in the disease field (such as cardiovascular disease, diabetes, etc.); 2. There is a known history of immediate or delayed Hypersensitivity of the same kind of drugs and excipients of the study drug; 3. Patients who refuse to take effective contraceptive measures during the study period; 4. Patients who participate in other interventional clinical studies at the same time; 5. Those who need treatment due to the merger of other malignant tumors; 6. Patients judged by the researcher to be unsuitable for participation in this study; 7. Patients who have previously used this protocol and have not received clinical treatment effectively.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Complete remission rate;progression-free survival;Overall survival;safety; | — |
Countries
China
Contacts
Public ContactYanli Wang
Shanxi Cancer Hospital/Cancer Hospital of the Chinese Academy of Medical Sciences, Shanxi Hospital
Outcome results
None listed