DLBCL
Conditions
Interventions
treatment group: mecapegfilgrastim
Control Group:No
Sponsors
West China Hospital,Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. The subjects aged 18 to 75 years old when they signed the informed consent, both male and female; 2. Patients with CD20-positive diffuse large B-cell NOS lymphoma diagnosed by histopathology who plan to receive standard R-CHOP or R-CHOP-like chemotherapy; 3. The subject has not received systemic chemotherapy for CD20-positive diffuse large B-cell lymphoma before; 4. ECOG score: 0-3 points; 5. Expected survival period >= 4 months; 6. Perform all screening laboratory tests as required by the protocol and within 14 days before the first chemotherapy dose. The values ??of laboratory tests performed for screening must meet the following criteria: (1) Routine blood examination: (no blood transfusion, no G-CSF use, and no drug correction within 14 days before signing the informed consent form) 1) Hemoglobin (HB) >= 90 g/L; 2) Absolute neutrophil count (ANC) >=2.0x10^9/L; 3) Platelet count (PLT) >= 80x10^9/L; 4) White blood cell count (WBC) >=4.0x10^9/L and =30 g/L; 4) Cr=60 mL/min (Cockcroft-Gault formula); 5) APTT <= 2 times ULN, while INR or PT <= 2 times ULN (not receiving anticoagulation therapy). 7. Fertile subjects must be willing to use reliable contraceptive measures during the clinical study and within 90 days after the last dose, and fertile female subjects must be pregnant within 7 days before the first dose of R-CHOP test, and the result is negative; 8. Voluntarily participate in clinical research and sign the informed consent.
Exclusion criteria
Exclusion criteria: 1. Target disease exclusion criteria: (1) Exclude pregnant or breastfeeding women; (2) Exclude those who are allergic to thiopefilgrastim, polyethylene glycol recombinant human granulocyte stimulating factor, recombinant human granulocyte stimulating factor and other preparations expressed by Escherichia coli; (3) Converted DLBCL; (4) History of hematopoietic stem cell transplantation; (5) Active infection and receiving systemic antibiotics within 72 hours before chemotherapy; (6) Patients with hematological diseases that can affect bone marrow function; (7) Severe liver, kidney, heart and lung dysfunction; (8) Exclude subjects who are participating in other clinical studies or whose first drug is less than 4 weeks away from the end of the previous clinical study (last dose) (or 5 half-lives of the study drug); (9) Subjects with a history of radiotherapy and chemotherapy for malignant tumors in the past. 2. Allergic reactions and adverse drug reactions: (1) Allergy or intolerance to infusion; (2) Have a history of severe allergy to rituximab, cyclophosphamide, doxorubicin, vincristine or their preventive medicines. 3. Exclude subjects with mental illness, drug addiction or drug abuse; 4. Other circumstances that are judged by the investigator to be unsuitable for inclusion in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence of grade =3 neutropenia in cycle 1;adverse events; | — |
Secondary
| Measure | Time frame |
|---|---|
| The incidence of grade =3 neutropenia in cycles 1 to 4;Incidence of febrile neutropenia among subjects in cycles 1-4 of chemotherapy;The incidence of chemotherapy delayed due to agranulocytosis;The incidence of chemotherapy dose reduction due to agranulocytosis;The proportion of total hospital stay =16 weeks;The incidence of infection and the use of antibiotics due to agranulocytosis in cycles 1 to 4;Changes of ANC in blood of cycle 1;Health economics evaluation: cost effectiveness analysis and cost utility analysis; | — |
Countries
China
Contacts
Public ContactNiu Ting
West China Hospital, Sichuan University
Outcome results
None listed