Diffuse Large B Cell Lymphoma, DLBCL
Conditions
Interventions
Experimental group:Received treatment with purinostat mesylate, with a dosage of 11.2 mg/m^2. Each administration cycle was given intravenously on days 1, 4, 8, and 11, with a 21-day cycle. The total
Control group:Take the selinexor tablets orally at a dose of 60 mg each time, on days 1 and 3 of each week (for example, Monday and Wednesday, or Tuesday and Thursday). One course consists of 4 weeks.
Sponsors
West China Hospital of Sichuan University/Ruijin Hospital of Shanghai Jiao Tong University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Inclusion Criteria: 1. Age >= 18 years, no gender restrictions; 2. Histologically-confirmed DLBCL, Participants must have relapsed or failed to respond to at least two lines of prior systemic therapy (2-5 lines); 3. The patient has measurable lesions. The criteria for measurable lesions are: the maximum long diameter of lymph node lesions measured by enhanced CT or MRI or PET-CT is greater than 15 mm and/or the maximum long diameter of extranodal lesions is greater than 10 mm; and is able to accept bone marrow puncture cytology examination and/or biopsy when evaluating the therapeutic effect.; 4.The patient received the last anti-tumor treatment before the first administration: the interval between systemic radiotherapy and the first administration of this study was>= 4 weeks; The interval between local radiotherapy or radiotherapy for bone metastasis is >= 2 weeks; Previous chemotherapy interval >= 3 weeks; Targeted therapy, biological therapy, immunotherapy, and other anti-tumor treatments must be administered at least 4 weeks after the first dose of this study [if CAR-T therapy, other chimeric antigen receptor immunotherapy, or autologous hematopoietic stem cell transplantation (auto HSCT) has been received at least 12 weeks after the first dose of this study]; 5.According to the researchers' assessment, the subject is currently not suitable for hematopoietic stem cell transplantation treatment; 6. ECOG12 weeks; 8.The blood routine must meet the following requirements: a) Absolute neutrophil count (ANC) >= 1.0 × 10^9/L; b) Hemoglobin (HGB)>= 80 g/L; c) Platelet count (PLT) >= 75 × 10^9/L, and no platelet or red blood cell suspension infusion within 2 weeks prior to screening; 9.The liver and kidney function test results meet the following criteria: a) serum total bilirubin (TBiL) = 50%; 11.Women and men of childbearing age must agree to take effective contraceptive measures from the signing of the informed consent form until 6 months after the last administration of the investigational drug. Female patients of childbearing age must have a negative serum pregnancy test result within 7 days before administration; 12.Participants must voluntarily sign an informed consent form, be able to communicate effectively with the researchers, and comply with the study plan's visits, treatment plans, laboratory tests, and other research procedures.
Exclusion criteria
Exclusion criteria: 1.Known to be severely allergic to the investigational drug or any of its excipients; 2.Primary central nervous system lymphoma or lymphoma invading the central nervous system; 3.DLBCL accompanied by mucosa associated lymphoid tissue (MALT) lymphoma, mixed lymphoma (Hodgkin's lymphoma+non Hodgkin's lymphoma), or DLBCL transformed from diseases other than indolent non Hodgkin's lymphoma or Richter's; 4.B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements (double/triple impact lymphoma);; 5.There are other active malignant tumors that may interfere with this study and require treatment; 6.History of solid organ or allogeneic hematopoietic stem cell transplantation; 7.Combined coagulation dysfunction, international normalized ratio (INR)>1.5 × ULN or prothrombin time (PT)>1.5 × ULN or activated partial thromboplastin time (APTT)>1.5 × ULN or thrombin time (TT)>1.5 × ULN or fibrinogen (FIB)10.0 mmol/L after drug treatment); b) Severe pulmonary disease (CTCAE V5.0 grades III-IV); c) Diagnosed by researchers or psychologists as having a history of mental illness, family history of mental illness, or emotional disorders, including medical records of depressive episodes, bipolar disorder (I or II), obsessive-compulsive disorder, schizophrenia, history of suicide attempts or suicidal ideation, or thoughts of murder (immediate risk of harming others), anxiety level 3 or above, et; 11.Pre trial treatment status: a) Previously received HDAC inhibitor therapy (excluding Chidamide Tablets) before the first administration; b) Patients who have previously received treatment with Celinosol; c) Within 3 months prior to the first administration, autologous hematopoietic stem cell transplantation treatment was performed; d) Systemic radiotherapy that affects the effic
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective remission rate;Overall survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Complete remission rate;Disease control rate;Duration of relief;Time to response;Progression free survival; | — |
Countries
China
Contacts
Public ContactTing Niu/ Weili Zhao
West China Hospital of Sichuan University/Ruijin Hospital of Shanghai Jiao Tong University School of Medicine
Outcome results
None listed