Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Sinocelltech Ltd.
Age
18–75
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
1. aged from 18 to 75 years;
2. having histologically confirmed NHL expressing CD20 antigen;
3. having obtained CR (complete remission) or CRu (uncertain complete remisson) after the prior therapy;
4. ECOG performance status of 0 to 1
5. expected survival of at least ≥ 3 months;
6. signed an informed consent form which was approved by the institutional review board of the respective medical center .
You may not be if
1. had received rituximab or other anti-CD20(+) monoclonal antibody treatment within 1 year before enrollment;
2. having to be at least 4 weeks beyond prior anticancer therapy including corticosteroid, or have not recovered from significant toxicities of prior therapy;
3. participating in other clinical trial within 30 days before enrolment;
4. with serious hematologic dysfunction (white blood cell count of \<3.0×103/uL; absolute neutrophil count of \<1.5×103/ uL; platelet count of \< 75×103/uL; hemoglobin level of \< 8.0 g/dL); hepatic dysfunction (total bilirubin level of \> 1.5×ULN; aspartate amino transferase (AST) and alanine amino transferase (ALT) levels of \>2.5 × ULN; renal dysfunction (serum creatinine level of \> 1.5×ULN ); and International normalized ratio (INR) and partial thromboplastin time or activated partial thromboplastin time (aPTT) \> 1.5 × ULN (unless on therapeutic coagulation);
5. had received live vaccine within 4 weeks prior to study entry;
6. with other malignancies ; or central nervous system (CNS) lymphoma, AIDS-related lymphoma; or active opportunistic infection, a serious nonmalignant disease;
7. seropositive for HCV antibody, or HIV antibody, or hepatitis B virus surface antigen (HBsAg). HBc antibody seropositive, but HBV DNA and HBsAg negative patients may participle following consultation with a hepatitis expert regarding monitoring and use of HBV antiviral therapy, and provided they agree to receive treatment as indicated,
8. recent major surgery (within 28 days prior to study entry );
9. with a history of allergic reaction or protein product allergy including murine proteins;
10. pregnant or lactating or not accepted birth control methods including male patients.
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