Neutrophil reduction after chemotherapy
Conditions
Interventions
Intervention group:Subcutaneous injection of Mecapegfilgrastim according to the patient's body weight 24-36 hours after chemotherapy
Sponsors
Capital Medical University, Beijing Children's Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Children with pathologically confirmed rhabdomyosarcoma and Ewing's sarcoma plan to complete at least one cycle of VAC/VDC regimen chemotherapy; 2.Aged <18 years; 3.Life expectancy = 3 months; 4.Karnofsky score = 70 (16 years old = age <18 years old) or Lansky score = 70 points (aged <16 years); 5.Laboratory tests during screening period should be consistent with: absolute neutrophil count (ANC) = 2.0 × 10^9 / L; alanine aminotransferase (ALT) and aspartate aminotransferase (AST) = 2.5 ×upper limit of normal (ULN) (liver metastasis) Patient = 5 × ULN); serum creatinine = 2.5 × ULN; 6.The subject's parent (or legal guardian) or adolescent patient agrees and signs an informed consent form (ICF).
Exclusion criteria
Exclusion criteria: 1.Patients with severe infections; 2.Patients with autoimmune diseases; 3.Patients with severe liver, kidney, heart, lung dysfunction; 4.Patients who are allergic to this product,rhG-CSF, other PEG-rhG-CSF or E. coli expression products; 5.Patients who participate in any clinical trial of similar drugs at the same time; 6.Patients who may not be able to comply with the protocol, who are unable to cooperate or patients who are believed that other conditions are not suitable for enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of neutropenia of 3 degrees and above; | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of neutropenic fever (FN);Delayed or reduced incidence of periodic chemotherapy due to neutropenia; | — |
Countries
China
Contacts
Public ContactXiaoli Ma
Outcome results
None listed