Diffuse large B-cell lymphoma
Conditions
Interventions
Test group:Combination regimen: rituximab + zebutinib + cedarbenamide:
Rituximab 375 mg/m^2, d0, intravenous infusion (IV), 6 cycles of induction therapy only 1 cycle every 21 days, which can be exten
Sponsors
Fujian Medical University Union Hospital
Eligibility
Sex/Gender
All
Age
60 Years to No maximum
Inclusion criteria
Inclusion criteria: Patients must meet all of the following inclusion criteria to be enrolled in this study: 1. age >= 60 years, male or female (not suitable for transplantation by physician judgement: transplantation includes autologous and allogeneic transplantation); 2. no previous treatment for DLBCL, including chemotherapy, targeted therapy, immunotherapy, local radiotherapy for lymphoma (except local radiotherapy for the relief of tumour-related symptoms), surgical treatment (except biopsy of tumour or pathological tissue and surgical resection not directed at lymphoma); 3. Histopathologically confirmed diagnosis of (the following conditions need to be met simultaneously): (1) Diffuse large B-cell lymphoma with CD20 positivity; (2) "MYC/BCL2 dual expression": expression of both MYC and BCL2, immunohistochemical WHO criteria: MYC >=40%, BCL2 >=50%; (3) Non-"double-strike" or "triple-strike": FISH test shows no "MYC and BCL2 rearrangement" or "MYC and BCL6 rearrangement". BCL6 rearrangement" or "MYC and BCL2 and BCL6 rearrangement". 4. At least one 18F-deoxyglucose (18FDG) positron emission computed tomography (PET-CT) positive lesion according to the Hodgkin's and non-Hodgkin's lymphoma 2014 Lugano criteria; 5. International Prognostic Index (IPI) score >1; 6. ECOG physical status score of 0, 1 or 2; 7. At screening, laboratory tests that meet the following criteria, unless in the opinion of the investigator they are due to lymphoma (corrective and supportive therapy for the parameters listed below has not been administered within 2 weeks prior to evaluation): (1) Routine blood tests: haemoglobin (Hb) >= 90 g/L, absolute neutrophil count (ANC) >= 1.5 x 10^9/L, platelet count (PLT) >= 90 x 10^9/L; (2) Biochemical tests: serum creatinine (Cr) <=1.5 × upper limit of normal (ULN); total bilirubin (TBIL) <=1.5 × ULN; alanine aminotransferase (ALT), alanine aminotransferase (AST) <=2.5 × ULN (liver metastasis cases: <=5 ULN). 8. Have a life expectancy of at least 6 months in the judgement of the investigator; 9. Understand and voluntarily sign the written informed consent; 10. the patient himself/herself or his/her legal guardian voluntarily sign an informed consent form agreeing to participate in the experimental treatment; 11. good compliance and willingness to comply with visit schedules, dosing schedules, laboratory tests, and other trial steps.
Exclusion criteria
Exclusion criteria: Patients with any of the following are not eligible for enrolment in this study: 1. concomitant CNS metastases or molluscum contagiosum metastases; 2. previous or current combination of primary CNS DLBCL, primary mediastinal (thymic) large B-cell lymphoma, unclassifiable B-cell lymphoma with features intermediate between DLBCL and classical Hodgkin's lymphoma (grey zone lymphoma), primary cutaneous DLBCL, indolent lymphoma, Burkitt's lymphoma, positive cutaneous mucocutaneous ulcers, chronic inflammation-related DLBCL, lymphomatoid granuloma, intravascular large B-cell lymphoma, ALK+ large B-cell lymphoma, plasmoblastic lymphoma, HHV8+ DLBCL, nasal lymphoma, primary testicular lymphoma; 3. transformed lymphoma, i.e. transformed from other types of lymphoma such as follicular lymphoma, marginal zone B-cell lymphoma and chronic lymphocytic leukaemia/small B-cell lymphoma; 4. previous organ transplantation, or haematopoietic stem cell transplantation; 5. previous or current co-morbidities of other malignancies, except adequately treated basal cell or squamous cell carcinoma of the skin, or carcinoma in situ of the cervix; 6. Previous use of any anti-CD20 antibody; 8. use of any interferon within 3 months prior to the first dose; 9. participation in other interventional clinical trials within 3 months prior to first dose; 10. history of severe allergic or hypersensitive reactions to humanised or murine monoclonal antibodies or known sensitivity or allergic reactions to murine products; 11. contraindications to the use of zebutinib, cedarbenamide and rituximab components; 12. Glucocorticoid use >30 mg/day prednisone or equivalent for purposes other than symptom control of lymphoma; the following allowable enrolments are subject to the appropriate requirements: (1) If on corticosteroid therapy, i.e., 470 ms (women) and >450 ms (men); (4) Other cardiovascular disease that, in the judgement of the investigator, makes enrolment inappropriate. 15. history of interstitial lung disease (ILD), such as pulmonary fibrosis, or evidence of ILD on baseline chest CT or MRI; 16. clinically significant gastrointestinal abnormalities that may interfere with drug intake, transit or absorption (e.g., inability to swallow, chronic diarrhoea, intestinal obstruction), or total gastrectomy; 17. History of deep vein thrombosis or pulmonary embolism; 18. active bleeding within 2 months prior to
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival of 2 years; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;Overall response rate;Complete remission rate after 6 cycles of induction;safety; | — |
Countries
China
Contacts
Public ContactShaoyuan Wang
Fujian Medical University Union Hospital
Outcome results
None listed