Relapsed/Refractory B-Cell Non-Hodgkin Lymphoma
Conditions
Interventions
experimental group:TQ-B3525 in combination with rituximab and bendamustine
Sponsors
Sichuan Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. The subject voluntarily joins the study and signs the informed consent; 2. No gender limitation, age: 18-75; ECOG (PS) score: 0-1; Estimated survival >= 3 months; 3. Patients with relapsed/refractory B-cell non-Hodgkin's lymphoma (NHL) confirmed pathologically or cytologically, including diffuse large B-cell lymphoma, follicular lymphoma, mantle cell lymphoma, marginal zone lymphoma, chronic lymphocytic leukemia/small lymphocytic lymphoma, etc. 4. They have received at least one systemic treatment plan in the past, and have had disease progression of during or after the last treatment, or have been confirmed to have no objective remission after adequate treatment; 5. After CT or MRI evaluation, there is at least one measurable tumor lesion in two vertical directions (according to Lugano standard of 2014 edition, the length diameter of intrknots lesion is > 15mm, and the length diameter of extrknots lesion is > 10mm); 6. The main organ functions during the screening period met the following criteria: Blood routine examination criteria (no growth factor or blood transfusion within 7 days) : absolute value of neutrophil (ANC) >= 1.5x10^9/L; Platelet (PLT) >= 75x10^9/L; Hemoglobin (Hb) >= 80 g/L; Blood biochemical test criteria: ALT and AST <= 2.5xULN (lymphoma involving liver or biliary tract obstruction =5×ULN); Serum total bilirubin (TBIL) <= 1.5xULN; Coagulation function: activated partial thrombin time (APTT), international standardized ratio (INR), prothrombin time (PT) <=1.5xULN; Serum creatinine (Cr) <=1.5xULN or creatinine clearance =50ml/min; 7. Women should agree to use contraception (IUD, birth control pill or condom) during the study period and for 6 months after the study; Negative serum or urine pregnancy test within 7 days prior to study enrollment and must be non-lactating; Men should agree to use contraception during the study and for six months after the study ends.
Exclusion criteria
Exclusion criteria: 1. Lymphoma patients with known central nervous system (CNS) involvement; 2. Prior treatment with PI3K inhibitors or bendamustine; 3. Known to be allergic to human or mouse monoclonal antibodies, mouse products, xenoproteins, or to TQ-B3525, bendamustine and excipients of the two drugs; 4. Has had or is currently co-existing with other malignancies within 3 years, except cured cervix carcinoma in situ, non-melanoma skin cancer, and superficial bladder tumors [Ta (non-invasive tumor), Tis (carcinoma in situ), and T1 (tumor infiltrating basal membrane)]; 5. Patients with previously diagnosed type I diabetes or uncontrolled Type II diabetes, or with fasting glucose > 8.9 mmol/L during the screening period, or with glycosylated blood red egg (HbA1c > 8.5% during the screening period; 6. Patients with a prior history of clinically diagnosed or drug-induced interstitial lung disease; 7. Persons who have a history of immunodeficiency, including but not limited to HIV positive or other acquired or congenital immunodeficiency diseases, or who have received organ transplantation (other than corneal transplantation); 8. People with multiple factors affecting oral medication (such as inability to swallow, chronic diarrhea and intestinal obstruction); 9. Non-hematologic toxicity caused by previous treatment has not recovered to grade 1 = CTC AE grade 2) during screening period; 13. Major surgery or unhealed obvious traumatic injury within 4 weeks before the first medication, except for tumor tissue biopsy for pathological diagnosis; 14. Received autologous hematopoietic stem cell transplantation within 3 months before the first medication; 15. Previous allogeneic hematopoietic stem cell transplantation; 16. Had >= II cardiovascular diseases within 6 months before the first medication, including unstable angina, myocardial infarction, arrhythmia requiring treatment, congestive heart failure, uncontrolled hypertension, cerebrovascular accidents (including transient ischemic attacks), etc.; 17. QTcF > 480ms and LVEF 1.0g within 7 days; 19. When the epidemiological test results during the screening period meet any of the following criteria: HBsAg positive and HBV DNA beyond the upper limit of the normal value (those reduced to the normal range after antiviral treatment can be included); Anti - HCV positive; 20. Those who have a history of psychotropic drug abuse and cannot get rid of it or have mental disorders; 21. Patients with other serious physical or mental disorders or abnormal labor
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate, ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival, PFS;Disease control rate, DCR;Overall survival, OS; | — |
Countries
China
Contacts
Public ContactTongyu Lin
Sichuan Cancer Hospital
Outcome results
None listed