Angioimmunoblastic T-cell lymphoma (AITL)
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. The patient fully understands this study and voluntarily participates in it. 2. Age: >= 18 years old. 3. The expected survival time is >= 3 months. 4. Angioimmunoblastic T-cell lymphoma (AITL) diagnosed by histopathology. 5. Patients with newly diagnosed cases or relapsed patients who have received at least one line of systemic treatment with an anthracycline-containing regimen in the past. Relapsed and refractory is defined as relapse after complete remission (CR), or failure to achieve partial remission after 2 cycles of initial chemotherapy, and failure to achieve complete remission after 6 cycles of chemotherapy. 6. There must be at least one evaluable or measurable lesion that meets the Lugano 2014 criteria: for lymph node lesions, the measurable lymph nodes should have a long diameter > 1.5 cm; for non-lymph node lesions, the measurable extranodal lesions should have a long diameter > 1.0 cm. 7. Eastern Cooperative Oncology Group (ECOG) performance status score is 0-2 points. 8. Hepatic and renal functions: Serum creatinine <= 1.5 times the upper limit of the normal value; Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) <= 2.5 times the upper limit of the normal value (<= 5 times the upper limit of the normal value for patients with liver invasion); Total bilirubin <= 1.5 times the upper limit of the normal value (<= 3 times the upper limit of the normal value for patients with liver invasion).
Exclusion criteria
Exclusion criteria: 1. Uncontrollable systemic diseases, that is, even after drug treatment, the control still fails to meet the standard, and the indicators are still higher than the normal ones in the disease field (such as cardiovascular diseases, diabetes, etc.); 2. A history of known immediate or delayed hypersensitivity reactions to drugs of the same class as the study drug and its excipient components; 3. Patients who refuse to adopt effective contraceptive measures during the study period; 4. Patients who are simultaneously participating in other interventional clinical studies; 5. Patients with other concurrent malignant tumors that require treatment; 6. Patients whom the investigator deems inappropriate to participate in this study; 7. Patients who have previously used this treatment regimen and showed no response to the clinical treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| CRR;mPFS;mOS;Safety; | — |
Countries
China
Contacts
THE FIRST HOSPITAL OF LANZHOU UNVERSITY