Diffuse Large B-cell Lymphoma
Conditions
Interventions
Group A:Orelabrutinib + RCHOP
Group B:Orelabrutinib + R-DA-EPOCH
Group C:Orelabrutinib + R-HD-MTX
Sponsors
The Third People's Hospital of Fujian Province
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Aged >= 18 years, no gender limit; 2. Eastern Cooperative Oncology Group (ECOG) physical fitness score of 0-2; 3. Histopathologically confirmed diffuse large B-cell lymphoma, CD20 positive; 4. One of the following conditions must be met to be included in the study: (1) The longest diameter of the mass assessed by CT or PET/CT is >=10 cm; (2) International Prognostic Index (IPI) >= 2 points; (3) There are more than 2 extranodal lesions; (4) Involvement of the central nervous system; (5) Secondary to the second tumor or combined with the second tumor; (6) Genetic abnormalities or molecular biological abnormalities with known poor prognosis, such as P53 gene mutation, MYD88/CD79B mutation, c-MYC/BCL2 double expression, c-MYC/BCL-2/BCL-6 double strike or triple strike; (7) CNS-IPI score >= 2 points; 5. Have not received treatment for DLBCL before, including chemotherapy, targeted therapy, immunotherapy, local radiotherapy for lymphoma (except local radiotherapy for relieving tumor-related symptoms), surgical treatment (except for tumor or pathological biopsy and surgical resection not for lymphoma); 6. Bone marrow and organ function meet the following criteria (no blood transfusion, no G-CSF use, no drug correction within 14 days before screening): (1) Bone marrow function: absolute value of neutrophils >= 1.5x10^9/L, platelets >= 75x10^9/L, hemoglobin >= 90 g/L; (2) Liver function: Serum total bilirubin = 60 mL/min (Male: Cr (ml/min) = (140-age) x body weight (kg) / 72 x serum creatinine concentration (mg/dl); Female: Cr (ml/min) = (140-age) x body weight (kg) / 85 x serum creatinine concentration (mg/dl)); 7. Subjects of childbearing potential who have no reproductive plans with their partners during the study period and within 3 months after discontinuation of treatment, during the entire study and within 3 months of interruption of treatment, one of the following effective contraception must be used: abstinence, physical contraception (such as ligation, condoms, etc.), hormonal contraceptive use was initiated at least 3 months prior to the first dose of enrollment. Male subjects were prohibited from donating sperm from the start of treatment to 3 months after treatment was stopped; 8. Understand and voluntarily sign the written informed consent; 9. Good compliance, willing to abide by the schedule of visits, dosing schedules, laboratory tests and other experimental procedures.
Exclusion criteria
Exclusion criteria: 1. Past or current combined with primary exudative DLBCL, unclassifiable B-cell lymphoma with features between DLBCL and classic Hodgkin lymphoma (gray zone lymphoma), indolent lymphoma, Burkitt lymphoma, Epstein-Barr virus-positive skin and mucosal ulcers, chronic inflammation-related DLBCL, lymphoma-like granuloma, intravascular large B-cell lymphoma, ALK+ large B-cell lymphoma, plasmablastic lymphoma, HHV8+DLBCL, NOS; 2. Transformed lymphoma, that is, transformed from other types of lymphoma, such as follicular lymphoma, marginal zone B-cell lymphoma, and chronic lymphocytic leukemia/small B-cell lymphoma; 3. Received organ transplantation or hematopoietic stem cell transplantation in the past; 4. Received cytotoxic drugs for other diseases (such as rheumatoid arthritis) or previously used any anti-CD20 antibody within 3 months before the first dose; 5. Have used any monoclonal antibody within 3 months before the first dose; 6. Participated in other interventional clinical trials within 3 months before the first medication; 7. Have a history of severe allergic reaction or allergic reaction to humanized or mouse-derived monoclonal antibodies or known sensitivity or allergic reaction to mouse-derived products; 8. Glucocorticoids > 30 mg/day, use prednisone or equivalent drugs for other purposes than lymphoma symptom control: (1) If you are receiving corticosteroid therapy, that is, 470ms (women) and > 480ms (men) during the screening period; (4) Coronary heart disease with symptoms requiring drug treatment during the screening period; 10. A history of interstitial lung disease (ILD), such as pulmonary fibrosis, or evidence of ILD on baseline chest CT or MRI; 11. Clinically obvious abnormalities of the gastrointestinal tract, which may affect the intake, transport or absorption of drugs (such as inability to swallow, chronic diarrhea, intestinal obstruction, etc.), or total gastrectomy, or combined with diseases affecting swallowing function; 12. Active bleeding within 2 months before the first dose, or taking anticoagulant drugs (such as warfarin, phenprocoumarin), or the investigator believes that there is a clear bleeding tendency (such as esophageal varices with bleeding risk, local active ulcer lesions, fecal occult blood >2+), except for bleeding caused by lymphoma itself as judged by the investigator (such as gastrointestinal bleeding cause
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete remission rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival;Overall survival;Overall response rate; | — |
Countries
China
Contacts
Public ContactFu Haiying
The Third People's Hospital of Fujian Province
Outcome results
None listed