Diffuse large B cell lymphoma
Conditions
Interventions
Experimental group:Hi-chop
Sponsors
Center for Cancer Prevention and Treatment of Sun Yat-Sen University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Histopathologically diagnosed with CD20 positive diffuse large B-cell lymphoma, non-specific type (DLBCL, NOS). Immunohistochemical CD20 is positive; 2. IPI for Lymphoma score: 0-3; 3. ECOGperformance status score of 0 - 2 selected; 4. Survival was expected to be > for 6 months; 5. Aged >= 18 and 1.5cm and short diameter >1.0cm;For extrinsic lesions, the length diameter should be >= 1.0cm. 7. Absolute value of neutrophils >= 1.5 x 10^9/L, PLT >= 75 x 10^9/L; 8. Liver function TBIL = 50% by echocardiography; 14. Women cannot participate in pregnancy and lactation; Women of childbearing age must be confirmed by a pregnancy test that they are not pregnant and are willing to take effective measures to prevent pregnancy during the study period and within 12 months after the last dose. All male subjects used contraception during the study period and >= 3 months after the last dose. 15. Sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Other types of DLBCL: chronic inflammation-related DLBCL, lymphomatoid granuloma, primary mediastinal large b-cell lymphoma, ALK-positive large b-cell lymphoma, primary exudative lymphoma, Burkitt lymphoma, high-grade b-cell lymphoma (including high-grade b-cell lymphoma, NOS and associated with MYC and BCL2 and/or BCL6 rearrangement of high level B cell lymphoma), B cell lymphoma classification (characteristics between DLBCL and the typical Hodgkin's lymphoma), rich in T cell tissue cells large B cell lymphoma, primary central nervous system (CNS) DLBCL, primary cutaneous DLBCL (legs), EBV positive DLBCL (NOS), EBV positive mucous membrane skin ulcers; 2. Transformed DLBCL (such as follicular lymphoma, chronic lymphoblastic leukemia/small b-lymphoblastic lymphoma transformed DLBCL), DLBCL secondary to central nervous system invasion; 3. History of malignant tumors other than squamous cell carcinoma of the skin, basal cell carcinoma of the skin and carcinoma in situ of the cervix in the past 5 years; 4. Perform major surgical operations (excluding diagnostic surgery) within the past 2 months; 5. Once received NHL treatment, including chemotherapy; Immunotherapy; Radiation therapy; Monoclonal antibody therapy; Surgical treatment (except diagnostic surgery and biopsy); 6. Previous treatment with cytotoxic drugs or monoclonal antibody to CD20 for other diseases (such as rheumatoid arthritis); 7. Any monoclonal antibodies were used within 3 months prior to enrollment; 8. Those who have participated in other clinical trials and used other trial-related drugs within 3 months before the disclosure; 9. Those who had received live (attenuated) virus vaccine within 1 month before inclusion; 10. Hematopoietic cytokines were used in the first 2 weeks before inclusion. 11. Prednisone or equivalent at a maximum dose of > 100mg for the purpose of controlling symptoms of lymphoma for more than 5 days; Prednisone > 30mg or equivalent corticosteroids daily for purposes other than symptomatic lymphoma control; For patients receiving prednisone less than or equal to 30mg or equivalent of corticosteroids per day, a written record must confirm that the dose was stable for at least 4 weeks prior to randomization; 12. Demyelinating patients with peripheral neuritis or charcot-marie-tooth syndrome; 13. Patients with suspected active or latent tuberculosis; 14. Patients with known active bacteria, viruses, fungi, mycobacterium, parasitic infection or other infection (excluding fungal infection of nail bed skin) or any major systemic infection event requiring intravenous antibiotic treatment or hospitalization (except neoplastic fever) within 4 weeks prior to enrollment; 15. Other serious conditions that may limit participation in the study, such as uncontrolled diabetes; Severe cardiac insufficiency; (NYHA grade II or above); Acute coronary syndrome occurred within 6 months; Coronary revascularization such as stenting, coronary bypass, and other heart and macrovascular procedures within the last 6 months; Severe arrhythmias include frequent ventricular premature, ventricular tachycardia, rapid atrial fibrillation/atrial fibrillation, and severe bradycardia.Uncontrolled hypertension: > 150/100mmhg); Gastric ulcers (stomach ulcers that researchers determine are at risk of perforation); Active autoimmune disease; Severe hypertension; Severe respiratory problems (e.g., obstructive pulmonary disease and a history of bronchospasm); 16. Contraindicati
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| Complete remission rate at the end of 6 cycles;duration of response, DOR;Progression-free survival, PFS; | — |
Countries
China
Contacts
Public ContactJun Zhu, Wenqi Jiang, Weili Zhao
Beijing Cancer Hospital
Outcome results
None listed