Diffuse large B-cell lymphoma
Conditions
Interventions
Interventions group:Radiotherapy combined with granulocyte macrophage stimulating factor, lenalidomide and girofetumab
Sponsors
The First Affiliated Hospital of Xiamen University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Signed written informed consent prior to the implementation of any trial-related procedures; 2. Age>=18 years, male or female, expected survival time of more than 3 months; 3. ECOG PS score of 0-3; 4. Diffuse large B-cell lymphoma confirmed by histopathological examination; 5. Patients who have received first-line standard therapy for primary drug resistance, short-term progression (within 1 year after the end of treatment) and failure of second-line standard treatment regimens; 6. Have not received bispecific antibody therapy in the past; 7. B-cell non-Hodgkin lymphoma with at least 1 measurable lesion according to criteria RECIST1.1; 8. Adequate organ function, subjects need to meet the following laboratory indicators: 1) total bilirubin =1.5× upper limit of normal (ULN); 2) Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) were = 60 ml/min; 4) good coagulation, defined as international normalized ratio (INR) or prothrombin time (PT) <=1.5 times ULN; 9. For female subjects of childbearing age, a urine or serum pregnancy test with a negative result should be received within 3 days prior to receiving the first dose of study drug (Cycle 1 Day 1), and a blood pregnancy test is required if the urine pregnancy test result cannot be confirmed as negative. Females of non-childbearing potential are defined as at least 1 year postmenopausal, or have undergone surgical sterilization or hysterectomy; 10. If there is a risk of conception, all subjects, male or female, are required to use contraception with an annual failure rate of less than 1% throughout the treatment period until 120 days after the last dose of study drug (or 180 days after the last dose of chemotherapeutic agent).
Exclusion criteria
Exclusion criteria: 1. Loss of CD20 expression in B-cell non-Hodgkin lymphoma; 2. Patients with acute or chronic active hepatitis B or hepatitis C infection, hepatitis B virus (HBV) DNA > 2000IU/ml or 10^4 copies/ml; Hepatitis C virus (HCV) RNA > 10^3 copies/ml; Hepatitis B surface antigen (HbsAg) is positive at the same time as anti-HCV antibodies; 3. There are central nervous system metastases, but the central nervous system metastases have no clinical symptoms or are accompanied by clinical symptoms, and the disease is controlled after treatment and the stable time is >=4 weeks, and they can be enrolled; 4. Subjects have received anti-hematologic tumor therapy within 2 weeks or 5 pharmacokinetic half-lives before starting treatment, whichever is longer; 5. Insufficient bone marrow reserve as defined by platelet count 150mmHg or diastolic blood pressure > 90 mmHg after optimal medical treatment, history of hypertensive crisis or hypertensive encephalopathy; 8. Symptomatic congestive heart failure (New York Heart Association class II-IV), symptomatic or poorly controlled arrhythmias, history of congenital long QT syndrome, or QTc >500ms corrected at screening) (calculated using the Fridericia method); 9. Hypofractionated radiation therapy within 4 weeks prior to the first treatment. For patients who have received radiation therapy more than 4 weeks before the first treatment, all of the following conditions must be met to be enrolled: there are no current radiotherapy-related toxic reactions, no need to take glucocorticoids, radiation pneumonitis, radiation hepatitis, radiation enteritis, etc.; 10. Patients with difficulty swallowing oral medications; 11. Previous and current history of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, drug-related pneumonia, severe impairment of lung function and other lung diseases; 12. Human immunodeficiency virus (HIV) infection (HIV 1/2 antibody positive), known syphilis infection; 13. Unhealed wounds, fractures, gastric and duodenal ulcers, persistent positive fecal occult blood, ulcerative colitis, etc., or other conditions that may cause gastrointestinal bleeding and perforation as judged by the investigator; 14. Severe infection in the active phase or poorly controlled clinically. Severe infection within 4 weeks prior to the first dose, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia; 15. Received major surgical treatment or significant traumatic injury 4 weeks prior to the first dose; 16. Received traditional Chinese medicine with anti-tumor indications within 2 weeks before the first dose; 17. Known hypersensitivity to any bispecific antibody or GM-CSF preparation components; 18. Treatment with other clinical trials wi
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Relief Rate (ORR);Complete remission rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival;Duration of relief;Overall survival (OS); | — |
Countries
China
Contacts
Public ContactZhiJuan Lin
The First Affiliated Hospital of Xiamen University
Outcome results
None listed