DLBCL
Conditions
Interventions
experimental group:R2-CHOP
Sponsors
Cancer Prevention and Treatment Center, Sun Yat-Sen University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. The double expression diffuse large B cell lymphoma was confirmed by histopathology. The positive rate of Bcl-2 and c-myc was more than 50% and 40% respectively; 2. Male or female patients: 18-80 years old; 3. Patients with ECoG physical condition score: 0-2 points; 4. Patients with IPI score >= 3; 5. Patients who have not received any anti-tumor treatment such as radiotherapy, chemotherapy, targeted therapy or stem cell transplantation; 6. There must be at least one patient with an evaluable or measurable lesion in accordance with Lugano 2014 standard [evaluable lesion: 18F fluorodeoxyglucose / positron emission tomography (18FDG / PET) examination showed an increased uptake of lymph nodes or extranodal areas (higher than liver) and pet and / or computed The features of tomography (CT) were in accordance with lymphoma; measurable lesions: nodal lesions > 15mm in length or extranodal lesions > 10 mm in length, accompanied by increased 18FDG uptake]. There was no measurable lesion and the uptake of 18FDG was increased. 7. The function of main organs is good, that is to say, the following requirements shall be met one week before admission: blood routine WBC >= 3.5 x 10^9 / L, neu >= 1.5 x 10^9 / L, Hb >= 80g / L, PLT >= 100 x 10^9 / L; the function of heart and liver is normal (total bilirubin = 50% measured by echocardiography. 9. Patients (including steroid drugs) without other anti-tumor concomitant treatment. 10. Pregnant women of childbearing age must carry out pregnancy test (serum or urine) within 14 days before entering the group, and the result is negative, and they are willing to use reliable methods of contraception during the test. 11. Patients without other serious diseases in conflict with the program. 12. The subjects volunteered to join the study, signed the informed consent, had good compliance and cooperated with the follow-up.
Exclusion criteria
Exclusion criteria: 1. Other types of DLBCL: chronic inflammation related DLBCL, lymphoma like granuloma, primary mediastinal large B-cell lymphoma, ALK positive large B-cell lymphoma, primary exudative lymphoma, Burkitt lymphoma, advanced B-cell lymphoma (including advanced B-cell lymphoma, NOS and advanced B-cell lymphoma with myc and BCL2 and / or BCL6 rearrangement), B Cell lymphoma can not be classified (between DLBCL and classical Hodgkin's lymphoma), primary central nervous system (CNS) DLBCL, EBV (+ DLBCL); 2. Transformed DLBCL (such as follicular lymphoma, chronic lymphoblastic leukemia / small B-cell lymphoma) with secondary central nervous system invasion. 3. In the past 5 years, patients with skin squamous cell carcinoma, skin basal cell carcinoma, cervical carcinoma in situ and other malignant tumor history; 4. Patients who have undergone major surgery in the past 2 months (excluding diagnostic surgery); 5. Patients who have received NHL treatment: including chemotherapy, immunotherapy, radiotherapy, monoclonal antibody treatment, surgical treatment (excluding diagnostic surgery and biopsy); 6. Patients who have previously received cytotoxic drugs or mAb CD20 antibody to treat other diseases (such as rheumatoid arthritis); 7. Patients who have previously received thalidomide, lenalidomide and other drugs; 8. Patients who have used any monoclonal antibody, participated in other clinical trials and used other test related drugs in the first three months of enrollment, and who have been vaccinated (attenuated) live virus vaccine in the first one month of enrollment; 9. Patients who had used hematopoietic cytokines within 2 weeks before admission; 10. Patients suspected of active or latent tuberculosis; 11. Patients with active bacteria, virus, fungus, Mycobacterium, parasite infection or other infection (excluding fungal infection of nail bed skin) or any major systemic infection event requiring intravenous antibiotic treatment or hospitalization (excluding tumor fever) are known within 4 weeks before enrollment; 12. Patients with other serious diseases that may limit their participation in the trial, such as: uncontrolled diabetes mellitus; severe cardiac insufficiency (NYHA grade II or above); acute coronary syndrome within the past 6 months; and In June, coronary artery revascularization, such as stent implantation, coronary artery bypass grafting, and other heart and large blood vessel related operations; severe arrhythmias include frequent ventricular premature, ventricular tachycardia, rapid atrial fibrillation / atrial flutter, and severe bradycardia. Uncontrolled hypertension: more than 150 / 100mmhg). Gastric ulcer (gastric ulcer at risk of perforation determined by researchers); active autoimmune disease; severe hypertension; severe respiratory diseases (such as history of obstructive pulmonary disease and bronchospasm), etc.; 13. Patients with contraindications to any drug included in any chop, including anthracycline antibiotics previously received; diabetics who could not tolerate prednisone treatment in this protocol; 14. Subjects had a history of alcohol or drug abuse; 15. Patients who are allergic to constitution, or known to be allergic to any active ingredients, excipients or mouse derived products or heteroprotein contained in this trial (including the chop protocol); 16. Patients with serious mental illness; 17. Patients who are unable to comply during the trial and / or follow-up phase; 18. The researchers th
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| CRR; | — |
Secondary
| Measure | Time frame |
|---|---|
| ORR;OS;PFS; | — |
Countries
China
Contacts
Public ContactZhiming Li
Cancer Center of Sun Yat-Sen University
Outcome results
None listed