diffuse large b-cell lymphoma
Conditions
Interventions
experimental group:selinexor combined with R-GemOx
Sponsors
Chongqing University Fuling hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Pathologically confirmed CD20 positive primary DLBCL or DLBCL transformed from previously confirmed inert lymphoma (such as follicular lymphoma); 2. Patients who have experienced recurrence or difficulty in treatment after receiving first-line treatment in the past are allowed to be included in the original refractory patients (defined as those who have not remitted after the end of first-line treatment or have relapsed within 6 months); 3. Age 18-75 years; 4. ECOG PS=2 ; 5. There are measurable lesions with PET positive results, with at least one lymph node lesion with a maximum diameter (LDi) greater than 1.5 cm or one extralymph node lesion with LDi greater than 1 cm (according to the 2014 Lugano classification); 6. ANC=1.5×10^9 /L;PLT=75×10^9 /L(No platelet transfusion within 14 days prior to study drug treatment);Hgb=80g/L(No red blood cell infusion within 14 days prior to study drug treatment); 7. AST or ALT=2.5×ULN,or =5×ULN When there is known lymphoma affecting the liver; TBIL=2×ULN, or =5×ULN when suffering from Gilbert syndrome or known lymphoma involving the liver;CrCl=30mL/min 8. Expected lifespan exceeding 3 months; 9. There are follow-up conditions and the patient voluntarily participates in this study and signs an informed consent form.
Exclusion criteria
Exclusion criteria: 1. DLBCL with mucosal associated lymphoid tissue (MALT) lymphoma; Mixed lymphoma (Hodgkin's lymphoma+non Hodgkin's lymphoma [NHL]); DLBCL converted from non inert NHL; Primary mediastinal (thymic) large B-cell lymphoma (PMBL); Large B-cell lymphoma rich in T cells; 2. There is evidence of central involvement; 3. Patients with a history of autoimmune diseases or a history of syndrome requiring systemic use of steroid immunosuppressants, such as pituitary inflammation, pneumonia, colitis, hepatitis, nephritis, hyperthyroidism, hypothyroidism, etc; 4. The patient received systemic glucocorticoid (prednisone>20mg/d) treatment (excluding nasal spray, inhalation or other topical glucocorticoids) or any other form of immunosuppressive treatment within 7 days before the first administration; 5. Uncontrolled heart disease, including unstable angina, acute myocardial infarction six months before randomization, and congestive heart failure (NYHA) with a heart function grading>III or IV; Or left ventricular ejection fraction<50%; 6. Previously received treatment with Selinexor; 7. Known allergies to investigational drug components; 8. Patients receiving organ transplants; 9. Other malignant tumors other than lymphoma or undergoing treatment, except for: ?Has received treatment for the purpose of cure, and has not experienced any known active disease of malignant tumors for at least 5 years before enrollment; ?Basal cell carcinoma of skin (excluding melanoma) with sufficient treatment and no signs of disease; ?Cervical carcinoma in situ with sufficient treatment and no signs of disease 10. Individuals who have experienced = Level 2 neurotoxicity reactions within the two weeks prior to treatment; 11. Merge severe infected individuals; 12. Substance abuse, medical, psychological, or social conditions that may interfere with participants' participation in research or evaluation of research results; 13. Other researchers believe that it is not suitable for enrollment.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Objective remission response;Progression-free survival;Safety; | — |
Primary
| Measure | Time frame |
|---|---|
| Complete response; | — |
Countries
China
Contacts
Public ContactYangzailiang
Chongqing university Fuling hospital
Outcome results
None listed