self-financing
Conditions
Interventions
experimental group:PEG-rhG-CSF
Sponsors
The Second Xiangya Hospital of Central South University; China Pharmaceutical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged 18 - 70 years male and female; 2. patients with primary malignant lymphoma diagnosed by histopathological or cytological studies and immunomolecular biology; Patients requiring multi-cycle chemotherapy alone or immunotherapy; 3. the following conditions are met: according to the judgment of the researchers, if the chemotherapy plan is not supported by rhG - CSF, FN risk >20% or FN risk 10% to 20%F (evaluation risk factors: previous chemotherapy or radiotherapy, persistent grain deficiency, tumor bone marrow invasion, recent surgery or trauma, liver dysfunction (bilirubin>2.0 ), renal dysfunction (creatinine clearance rate 65 and receiving full dose chemotherapy), and neoruibai is directly used 24 hours after chemotherapy; 4. the estimated survival time is more than 8 months; KPS score = 70 points; 5. bone marrow hematopoietic function is normal (ANC =1.5×10^9/L; PLT=80×10^9/L; Hb= 75g/LWBC =3.0×10^9/L); 6. no obvious abnormality was found in ECG and no obvious cardiac dysfunction was found; 7. all patients must agree to take effective contraceptive measures during the study period and within 6 months after stopping treatment. women of childbearing age must have negative urine pregnancy test before treatment and administration; 8. the subjects voluntarily participated in this clinical trial and signed the informed consent form.
Exclusion criteria
Exclusion criteria: 1) Lymphoma centers are involved; 2) those who have received hematopoietic stem cell transplantation or organ transplantation; 3) those who are currently conducting clinical trials of other drugs; 4) at present, there is an infection that is difficult to control. the body temperature is = 38 ?; 5) total bilirubin (TBIL), alanine aminotransferase (ALT) and aspartate aminotransferase ( AST) in liver function test are all >2.5 times the upper limit of normal value. if liver metastasis causes, the above index is > 5 times the upper limit of normal value. Renal function test: serum creatinine ( Cr ) > 2 times the upper limit of normal value 6) patients with serious chronic diseases of heart, kidney, liver and other important organs; 7) there are serious uncontrolled diabetes patients; 8) female patients during pregnancy or lactation; 9) those who have allergic diseases or belong to allergic constitution, or those who are allergic to this product or other biological products derived from genetically engineered Escherichia coli; 10) suspected or actual drug addicts, drug abusers and alcoholics; 11) serious mental or nervous system diseases that affect the expression or observation of informed consent and / or adverse reactions; 12 ) HIV - positive patients.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Duration of 3 - and 4 - degree neutropenia (ANC) reduction in each group during the first observation period; | — |
Contacts
Public ContactChongqing Tan
The Second Xiangya Hospital of Central South University
Outcome results
None listed