CD20-positive B-cell non-Hodgkin Lymphoma
Conditions
Interventions
250mg/m2:CD20
375mg/m2:CD20
500mg/m2:CD20
625mg/m2:CD20
Sponsors
Sun Yat-Sen University Cancer Center
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Ages from 18 to 65 years old; 2. Had a histopathologically confirmed diagnosis of CD20-positive on-Hodgkins lymphoma (NHL); 3. Had previously received at least 1 course of the following standard antitumor regimen: (1) Refractory/relapsed follicular lymphoma (FL), small lymphocytic lymphoma/chronic lymphocytic leukemia (SLL/CLL), marginal-zone lymphoma (MZL); (2) Diffuse large B cell lymphoma (DLBCL) and mantle cell lymphoma (MCL) without effective treatment; (3) Patients with FL, SLL or MZL who achieved a complete response (CR)/unconfirmed CR (CRu), partial response (PR), table disease (SD) after induction therapy without rituximab; (4) Patients with DLBCL or MCL who achieved CR(CRu),PR or SD after induction therapy without rituximab; (5) Patients with refractory/relapsed DLBCL or MCL who have achieved CR/Cru after salvage chemotherapy and were not scheduled for auto-peripheral blood stem cell transplantation (aPBSCT); 4. The Eastern Cooperative Oncology Group (ECOG) score was 0 and 1 at enrollment, and the expected survival time was > 12 weeks; 5. A highly effective method of contraception (e.g., oral contraceptive, intra-uterine (contraceptive) device, abasement of libido or barrier contraceptive combined with spermicide) must have been used during the course of the trial for fertile males or females, and the female continued to use contraception for 12 months after the end of treatment (males for 3 months); 6. Signed informed consent and volunteered to participate in clinical trials.
Exclusion criteria
Exclusion criteria: 1. Laboratory examinations revealed any of the following abnormalities prior to the trial: (1) Routine blood analysis: white blood cell (WBC) counts 1.5*upper limit of normal; alanine transaminase (ALT) or aspartate aminotransferase (AST) > 2.5*upper limit of normal without liver invasion; ALT or AST > 5*upper limit of normal when liver invaded; (3) Renal function: creatinine > 1.5*upper limit of normal; (4) Have positive results of human immunodeficiency virus (HIV) or hepatitis C virus (HCV); a positive result of hepatitis B virus (HBV)-DNA (with a quantitative detection limit of 500 IU/mL) was also detected in hepatitis B surface antigen (HBsAg) or hepatitis B surface core antibody (HBcAb) positive patients. 2. Patients who received other anti-tumor therapy (including corticosteroid therapy) or participated in other clinical trials within 4 weeks prior to the start of this trial, or had not recovered from previous toxicity; 3. Patients treated with rituximab or other anti-CD20 mAbs within 1 year; 4. Patients who had been treated with hematopoietic stimulants such as colony stimulating factor and erythropoietin within 1 week prior to the start of the trial; 5. Patients who received a live vaccine within 4 weeks prior to the start of the trial; 6. Patients who received major surgery (excluding diagnostic surgery) within 4 weeks prior to the start of the trial; 7. Patients who received autologous stem cell transplantation (ASCT) or radioimmunotherapy (RIT) within 3 months prior to the start of the trial; 8. Had a pleural effusion or ascites secondary to lymphoma; 9. Evidence of central nervous system (CNS) disease (including CNS lymphoma) and AIDS-related lymphoma; 10. Patients at risk for tumor lysis syndrome (TLS), as evaluated by the investigators; 11. Had a previous history or present malignancies (except stage IB or lower cervical cancer that had been cured, non-invasive basal cell or squamous cell skin cancer; breast cancer achieved CR of more than 10 years, malignant melanoma achieved CR of more than 10 years, and other malignancies achieved CR of more than 5 years were also excluded); 12. Other severe, uncontrolled concomitant diseases that may affect protocol compliance or interfere with results interpretation including active opportunistic or progressive (severe) infections, uncontrolled diabetes, cardiovascular disease (stage III or IV heart failure as defined by the New York Heart Association classification; degree II or higher heart block; myocardial infarction, unstable arrhythmia, or unstable angina have occurred in the past 6 months; cerebral infarction occurred within 3 months), or pulmonary disease (A history of interstitial pneumonia, obstructive pulmonary disease, or symptomatic bronchospasm); 13. Female who were pregnant or breastfeeding, or who do not use effective contraception; 14. Patients considered unfit to participate in this trial, as evaluated by the investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and tolerability;Pharmacokinetic analysis;Pharmacodynamic evaluation;Clinical efficacy evaluation; | — |
Countries
China
Contacts
Public ContactWenqi Jiang
Sun Yat-Sen University Cancer Center
Outcome results
None listed