Non-Hodgkin's lymphoma
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Aged >= 18 years of age with no gender limit; 2. The patients must be confirmed by pathological examination as CD20-positive B-cell relapsed follicular lymphoma (pathological grading as grade I, II, IIIA) or marginal zone B-cell lymphoma within half a year, and the single drug therapy with CD20 monoclonal antibody can be effective judged by investigators; 3. At least one measurable lesion: non-radiation injury, at least one of the 2 vertical diameters was > 1.5cm; 4. ECOG performance status score is 0-2 at the time of selection; 5. The interval from the last systematic anti-tumor treatment must be more than 4 weeks (if it was carmustine, the interval should be more than 6 weeks); 6. There must be no glucocorticoid treatment within 28 days, or the dosage of prednisone is no more than 20 mg / day for relieving symptoms other than lymphoma or lymphoma related symptoms; 7. Blood routine examination: WBC >= 3 x 10^9 / L; NEUT >= 1.5 x 10^9 / L; Hgb >= 80g / L; PLT >= 75 x 10^9 / L (except due to bone marrow involvement of lymphoma); liver function: TBIL <= 2 times of the upper limit of normal value; ALT or AST <= 2.5 times of the upper limit of normal value without liver invasion; ALT or AST <= 5.0 times of normal value under liver invasion; renal function: Cr <= 1.5 times of upper limit of normal value; 8. The expected survival time should be more than 3 months; 9. ADA is negative; 10. No live virus vaccine inoculated within 28 days before the treatment, and the virus live vaccine cannot be accepted util half a year after the last medication; 11. Sign the informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients who transform into higher grade lymphoma; 2. Patients with rituximab resistance (defined as: patients treated with rituximab based treatment have never obtained a efficacy >= PR, or disease progression occurs during rituximab treatment, or disease progression occurs within half a year after the drug withdrawal); 3. Those who have received monoclonal antibody therapy within half a year; 4. Patients with central nervous system involvement lymphoma; 5. Patients who meet any of the following conditionsHIV positive, HCV antibody positive with HCV RNA positive, HBsAg positive or HBcAb positive with HBV DNA replication level > 10^3; 6. Pregnant and lactating women; 7. Other serious and uncontrollable concomitant diseases that may affect compliance in the trail or affect the explanation of results, including active opportunistic infections or progressive (severe) infections, uncontrolled diabetes disease, cardiovascular disease (grade III or IV heart failure defined by the New York Heart Association classification, above II degree cardiac conduction block, myocardial infarction in the past 6 months, unstable arrhythmia or unstable angina pectoris, cerebral infarction within 3 months, etc.) or pulmonary disease (interstitial pneumonia, obstructive pulmonary disease and history of symptomatic bronchospasm); 8. Patients who were considered unsuitable for the study; 9. Suffering or having suffered from any other malignant tumor within 5 years; 10. Chronic or currently active infectious diseases requiring systemic antibiotics, antifungal drugs or antiviral treatment; 11. Women with positive blood / urine pregnancy test at the time of screening or who are breast feeding; 12. Women of child bearing potential or male study participants of reproductive potential refuse to use birth control method of contraception from enrolled the study to 1 year after completing study treatment.; 13. Patients with allergy to rituximab which was defined as transfusion reaction or allergic reaction still occurred during the second infusion of rituximab.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR; | — |
Countries
China