Acute myeloid leukemia (AML)
Conditions
Interventions
Experimental group:mecapegfilgrastim
Sponsors
Sichuan Provincial People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. AML with consolidation therapy other than acute promyelocytic leukemia diagnosed by bone marrow cell morphology, immunology, molecular biology and cytogenetics; 2. The prophylactic use of PEG-rhG-CSF after chemotherapy is aimed at preventing neutropenia, and the chemotherapy regimen must meet the interval of at least 28 days between two chemotherapy; 3. Complete remission was achieved after the initial induction chemotherapy efficacy evaluation; 4. Aged 18-75 years; 5. ECOG PS score 0-2 points; 6. The expected survival time is >=3 months after treatment; 7. Laboratory examination indicators meet the following requirements: total bilirubin <= 1.5 times the upper limit of normal, AST and ALT <= 2.5 times the upper limit of normal, serum creatinine < 2 times the upper limit of normal, myocardial enzymes < 2 times the upper limit of normal; 8. Before the trial, have a detailed understanding of the nature, significance, possible benefits, possible inconveniences and potential dangers of the trial, understand the research procedures and voluntarily sign the informed consent in writing; according to the investigator's judgment, thiopefilgrastim needs to be administered and can benefit.
Exclusion criteria
Exclusion criteria: 1. Patients with combined fever and neutropenia (FN); 2. WHO AML classification belongs to patients with acute panmyeloproliferation with myelofibrosis and myeloid sarcoma in the AML subclass not otherwise classified; 3. Suffering from malignant tumors of other organs at the same time (those who need treatment); 4. There are drug abuse, medical, psychological or social conditions that may interfere with the subject's participation in the research or the evaluation of the research results; 5. Pregnant or breastfeeding patients, patients of childbearing age who refuse to accept contraceptive measures; 6. Severe liver, kidney, heart and lung dysfunction; 7. Patients who are known to be allergic to thiopefilgrastim, recombinant human granulocyte-stimulating factor, pegylated recombinant human granulocyte-stimulating factor, and E. coli expressed products; 8. Those who participate in clinical trials of any similar drugs at the same time; those who may not be able to comply with the protocol or cannot cooperate, and those who are considered inappropriate by the investigator for other circumstances.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Neutrophil recovery time; | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence and duration of grade III / IV neutropenia;Duration of neutropenia;Incidence of fever with neutropenia;Proportion of patients with reduced dose or prolonged cycle of chemotherapy;Length of stay (duration from day 1 to discharge);Incidence of infection;Safety: adverse events (AE), serious adverse events (SAE);Economic analysis; | — |
Countries
China
Contacts
Public ContactHuang Juan
Sichuan Provincial People's Hospital
Outcome results
None listed