Lymphomas
Conditions
Interventions
Sponsors
Institute of Hematology and Oncology, Harbin The First Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: (1) Age: =18 years; (2) Patients with pathologically histologically confirmed CD20-positive B-cell non-Hodgkin's lymphoma ,meeting any of the following criteria: a) previously untreated; b) having received up to second-line therapy, including chemotherapy, immunotherapy, and local radiotherapy for lymphoma; (3) ECOG score is 0-2; (4) More than 6 months life expectancy ; (5) Normal liver and kidney function, specifically serum direct bilirubin, serum indirect bilirubin and/or glutathione aminotransferase, glutamic oxalacetic aminotransferase, serum creatinine = 2 x upper limit of normal (ULN), and creatinine clearance = 60 mL/min; (6) Patients with adequate hematologic function, regardless of bone marrow invasion or not, must meet the following indicators: absolute neutrophil count = 1.0 × 109/L and platelet count = 50 × 109/L; (7) For men or women of childbearing age who have not undergone sterilization, consent for contraception during treatment and for 6 months after the last dose of Ripertamab is required; (8) Subjects voluntarily enrolled in this study and signed an informed consent form with good compliance and cooperation with follow-up. (9) Patients who can benefit from treatment with repatumumab are evaluated by the investigator.
Exclusion criteria
Exclusion criteria: (1) Contraindication to any drug in the treatment regimen; (2) Pregnant or lactating women; (3) Those with disease involving the central nervous system; (4) Prior other malignancies (except cured basal cell carcinoma or squamous cell carcinoma of the skin, or melanoma of the skin or carcinoma in situ of the cervix) (5) Comorbidities with significantly poorly controlled conditions that may affect compliance with the study protocol, such as severe cardiovascular disease, peripheral or central nervous system disease (6) Those with positive HCV antibodies and a qualitative HCV-RNA test = 104 copies/mL; or HBV test results: HBsAg positive and/or HBcAb positive and HBV DNA titers above 1000 IU/mL or 1000 copies/mL (7) Have uncontrolled heart disease, including unstable angina, acute myocardial infarction within 6 months prior to the first dose, congestive heart failure (NYHA) cardiac function class III or IV; or cardiac left ventricular ejection fraction <50%; (8) A history of immunodeficiency, including those who are HIV positive or have other acquired or congenital immunodeficiency diseases or a history of organ transplantation (9) Patients who, in the opinion of the investigator, are not suitable for enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Response Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Complete Response Rate;Duration of Response;12 months Progression-free survival ;12-month overall survival rate ; | — |
Countries
china
Contacts
Public Contactma jun
Institute of Hematology and Oncology, Harbin The First Hospital
Outcome results
None listed