Hematological tumors
Conditions
Interventions
The treatment group with Telpegfilgrastim:None
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Patients aged >= 18 years; 2. Patients with primary or recurrent malignant hematologic tumors who meet the diagnostic criteria (morphology, histochemistry, genetics, molecular biology, flow cytometry, etc.): including acute lymphoblastic leukemia, Hodgkin lymphoma, non-Hodgkin lymphoma; 3. Receiving chemotherapy regimens with a medium- and high-risk risk of FN ; 4. Eastern Cooperative Oncology Group (ECOG) performance status = 1.5×10^9/L, PLT (platelet count) >= 70×10^9 /L, Hb (hemoglobin) >=75g/L, WBC (white blood cell count) >=3.0×10^9/L; 6. Written informed consent is obtained.
Exclusion criteria
Exclusion criteria: 1. Patients who are allergic to Telpegfilgrastim or its excipient components; 2. Those who have received hematopoietic stem cell transplantation or organ transplantation; 3. Ongoing clinical trials of other drugs; 4. Presence of uncontrollable infection; 5. Liver function test: liver function indexes (TBIL, ALT and AST) > 2.5 times the upper limit of normal value; Patients with hematological tumors with hepatic invasion or hepatic invasion have liver function indexes (TBIL, ATL and AST) > 5 times the upper limit of normal; 6. Pregnant or lactating female patients; 7. As judged by the investigator, the patient has other conditions that are not suitable for enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of grade 3-4 neutropenia (CIN) in the first cycle of chemotherapy after prophylaxis; | — |
Secondary
| Measure | Time frame |
|---|---|
| The incidence of febrile neutropenia (FN) within the first chemotherapy cycle after prophylactic medication;Incidence of grade 3-4 neutropenia (CIN) and incidence of febrile neutropenia (FN) in the 1-4 cycle of chemotherapy after prophylactic use;Dose of chemotherapy drug regimen, incidence of grade 3-4 CIN in chemotherapy cycle, incidence of FN in chemotherapy cycle, incidence of CIN in primary prevention and secondary prevention between young patients (= 65 years old);The distribution of different types of blood tumors, as well as the incidence of grade 3-4 CIN during chemotherapy cycles, the incidence of FN during chemotherapy cycles, and the incidence of primary and secondary prevention of CIN and FN among different types of blood tumors;;Incidence of rehospitalization;Occurrence of infection and use of antibiotics;After prophylactic use, the incidence of CIN and FN during primary and secondary prevention;The incidence of grade 3-4 neutropenia (CIN) and febrile neutropenia (FN) during the 2-4 chemotherapy cycles after prophylactic medication; | — |
Countries
China
Contacts
Public ContactNiu Ting
West China Hospital of Sichuan University
Outcome results
None listed