Diffuse large B-cell lymphoma
Conditions
Interventions
Sponsors
Cancer center of Sun Yat-Sen University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Previously untreated patients with a confirmed pathologic diagnosis of Diffuse large B cell-non-Hodgkin's lymphoma (DLBCL) and CD20 positive in immunohistochemical test. 2. The international prognostic index (IPI) score 0-3, stage I-IV; 3. ECOG is 0-2; 4. The estimated survival time should be more than 6 months; 5. Aged >= 18 to = 1.5cm and short diameter >= 1.0cm for intranodal lesions; the long diameter >= 1.0cm for extranodal lesions; 7. WBC >= 4 x 10^9 / L, Hgb >= 90g / L, absolute neutrophil count >= 2 x 10^9 / L, PLT >= 100 x 10^9 / L, It can be also allowed if the above indicators are within the normal range of local laboratory; patients with bone marrow invasion need to meet the following conditions: WBC >= 3 x 10^9 / L, Hgb >= 80g / L, absolute neutrophil count >= 1.5 x 10^9 / L, PLT >= 75 x 10^9 / L; 8. Liver function: TBIL = 50% ; 13. Pregnant and lactating women are not allowed to participate; women of child bearing potential must be not pregnant confirmed by pregnancy test, and they are willing to take effective contraceptive measures during the study period and until 12 months after the last administration at least ; all male subjects take contraceptive measures during the study period and until at least 3 months after the last administration; 14. Sign the informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients with primary central nervous system lymphoma or secondary central nervous system involvement, gray zoon lymphoma between Burkitt and DLBCL, gray zoon lymphoma between DLBCL and HL, primary mediastinal DLBCL, primary exudative lymphoma, plasmablastic lymphoma, primary cutaneous DLBCL, ALK positive DLBCL, transformed lymphoma, primary testicular DLBCL; 2. Double (Bcl-2 and c-myc gene rearrangements) or triple (Bcl-2, bcl-6 and c-myc gene rearrangements) hit DLBCL confirmed with FISH test. For the patients without clear FISH result, the results of immunohistochemistry show that the positive rate of Bcl-2 >= 70% and c-myc >= 40% , and the lymphoma cells originated from germinal center according to Han's evaluation criteria; 3. Patients with a history of malignant tumors except skin squamous cell carcinoma, skin basal cell carcinoma and cervical carcinoma in situ within 5 years,; 4. Major surgical operations (excluding diagnostic surgery) within 2 months; 5. Once received treatment for NHL: including chemotherapy, immunotherapy; radiotherapy (excluding local radiotherapy); monoclonal antibody therapy; surgical treatment (except biopsy); 6. Previous treatment with cytotoxic drugs or CD20 monoclonal antibody for other diseases (such as rheumatoid arthritis); 7. Any monoclonal antibodies use within 3 months prior to enrollment; 8. Participants in other clinical trials within 3 months before enrollment; 9. Patients vaccinated live (attenuated) virus vaccine within 1 month before enrollment; 10. Hematopoietic cytokines use within 2 weeks before enrollment; 11. Daily use of prednisone > 30mg or other equivalent corticosteroid to control the symptoms of lymphoma; for patients receiving daily prednisone <= 30mg or other equivalent corticosteroid drug, a stable corticosteroid doses for at least 4 weeks before randomization shoould be documented; 12. Peripheral nervous system or central nervous system diseases; 13. Active or latent tuberculosis suspects; 14. Active bacteria, virus, fungus, mycobacteria, parasitic infections or other infections (excluding nail bed fungal infections) or any major systemic infection requiring intravenous antibiotic treatment or hospitalization within 4 weeks before enrollment; 15. Other serious diseases that may restrict subjects from participating in the trial (e.g., uncontrollable diabetes mellitus; severe cardiac insufficiency; myocardial infarction or unstable arrhythmia or unstable angina pectoris in the past 6 months; gastric ulcer (gastric ulcer at risk of perforation judged by the investigators); active autoimmune disease; severe hypertension); 16. Contraindication to any of the individual components of CHOP, including prior receipt of anthracyclines; patients with diabetes who can not tolerate prednisone treatment in this program; 17. The subjects with a history of alcoholism or drug abuse; 18. History of allergic or anaphylactic reactions to any active ingredients and excipients included in this trial (including CHOP), or known sensitivity or allergy to murine products and foreign protein; 19. Patients with serious mental illness; 20. Patients who are unable to comply during the trial and / or follow-up phase; 21. Not suitable for the study for other specific reasons judged by investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR; | — |
Countries
China
Contacts
Public ContactWenqi Jiang
Cancer Center of Sun Yat-Sen University
Outcome results
None listed