lymphoma
Conditions
Interventions
Observation group:None
Sponsors
Shanghai Sixth People's Hospital
Eligibility
Sex/Gender
All
Age
8 Years to 50 Years
Inclusion criteria
Inclusion criteria: Potential Akilense injection subjects must meet the drug indication to be enrolled in this study. 1. Age 8-50, gender unlimited. 2. Histopathologically confirmed lymphoma with first-line treatment failure. However, it did not include patients with the following conditions: a. non-stable intracranial metastases b. multiple pelvic metastases c. Large vessels (femoral vessels, iliac vessels, abdominal vessels, axillary vessels, subclavian vessels) tumor thrombus formation d. Accompanied by a body cavity effusion 3. Failure of first-line chemotherapy for lymphoma. 4. Patients with disease progression within 6 months after the end of first-line chemotherapy with neoadjuvant or adjuvant chemotherapy, and patients with disease progression over 6 months need to obtain consent from the subject himself or his legal representative. 5. Measurable lesions at baseline as per RECIST version 1.1. 6. The ECOG physical status score is 0-1, and the expected survival period is more than 3 months. 7. Recovery from previous treatment: According to NCI-CTC AE 4.0, all side effects (except hair loss) resolved to grade 1 or below. 8. The following peripheral blood imaging and blood biochemical indicators suggest appropriate organ function: Hemoglobin (Hb) = 90g/L, Neutrophil (ANC) =1.5×109/L, Platelet count (Plt) = 80×109/L, Serum creatinine (Cr) = 1.5× upper limit of normal (ULN), blood urea nitrogen (BUN) = 2.5× upper limit of normal (ULN); Total bilirubin (TB) = ULN; Alkaline phosphatase (ALP) = 2.5×ULN; Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) = 2.5×ULN; Albumin (ALB) = 25 g/L. 9. Pregnancy test (urine beta-HCG) 10. Sign informed consent forms (or signed by legal representatives) to demonstrate that they understand the purpose of the study and the procedures required by the study, and are willing to participate in the study. Subjects under the age of 18 should sign a minor informed consent form.
Exclusion criteria
Exclusion criteria: Potential participants who meet any of the following criteria must be excluded from the study: 1. Within 3 weeks after the last systemic cytotoxic drug therapy, radiation therapy or any experimental drug therapy. 2. Other malignant tumors within the past 3 years. Exceptions: basal cell carcinoma of the skin or non-metastatic squamous cell carcinoma, carcinoma in situ of the cervix, or FIGO stage 1 cervical cancer. 3. Active central nervous system metastasis. 4. Myocardial infarction, New York Heart Society Class II or above heart failure, uncontrolled angina, uncontrolled severe ventricular arrhythmia, clinically significant pericardial disease, or electrocardiogram evidence of acute ischemia or active conduction system abnormalities within the 6 months prior to enrollment. 5. Uncontrolled comorbidities, including but not limited to: poorly controlled hypertension or diabetes, persistent active infections, or mental illness or social conditions that may affect participants' compliance with the study. 6. Pregnancy or lactation. 7. Any condition which, in the opinion of the investigator, is likely to harm the subject or cause the subject to be unable to meet or perform the study requirements.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate;Disease Control Rate;Duration of Response;progression-free survival;Overall survival; | — |
Countries
China
Contacts
Public ContactHaiyan Hu
Shanghai Sixth People's Hospital
Outcome results
None listed