Langerhans cell histiocytosis
Conditions
Interventions
Intervention group:PEG-rhG-CSF
Sponsors
West China Second University Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
0.5 Years to 18 Years
Inclusion criteria
Inclusion criteria: 1. Participants aged between 6 and 18 years; 2. Pediatric patients with LCH enrolled in a prospective real-world study involving Dabrafenib or Trametinib combined with Clofarabine for the treatment of high-risk, recurrent, or refractory LCH; 3. Occurrence of Grade 3 or higher neutropenia following subcutaneous administration of short-acting rhG-CSF after initial chlorpromazine use; 4. Expected survival period exceeding 3 months; 5. Normal bone marrow hematopoietic function and absence of bleeding tendencies; 6. The Eastern Cooperative Oncology Group (ECOG) performance status is between 0 and 2; 7. Participants must fully comprehend and adhere to the study requirements and voluntarily provide informed consent by signing the consent form.
Exclusion criteria
Exclusion criteria: 1. Individuals with known allergies to recombinant human granulocyte colony-stimulating factor (rhG-CSF), polyethylene glycol-conjugated rhG-CSF, or their excipients; 2. Presence of local or systemic infections that are inadequately controlled; 3. A history of bone marrow or hematopoietic stem cell transplantation; 4. Severe dysfunction of visceral organs, indicated by liver function tests showing total bilirubin (TBIL), alanine aminotransferase (ALT), and aspartate aminotransferase (AST) levels exceeding five times the upper limit of normal, or renal function tests showing serum creatinine (Cr) levels greater than twice the upper limit of normal; and the presence of severe primary diseases affecting the cardiovascular, hepatic, renal, endocrine, or hematological systems; 5. Individuals with specific pathogenic infections include: patients diagnosed with Hepatitis B, characterized by HBsAg positivity and HBV DNA detection indicative of viral replication; patients with Hepatitis C, identified by HCV antibody positivity and HCV-RNA detection suggestive of viral replication; individuals with positive syphilis screening, excluding those with positive specific antibody testing, negative non-specific antibody testing, and clinically confirmed as non-active phase infection; and those with a known history of HIV positivity or positive HIV screening results; 6. Within the first four weeks of enrollment, the use of other investigational drugs of the same type is prohibited; 7. Researchers also have the discretion to exclude patients deemed unsuitable for participation due to other underlying conditions, such as primary immunodeficiency, heart failure, kidney failure, hepatitis virus infection, HIV infection, or a history of organ transplant surgery.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence of grade 3/4 neutropenia during each chemotherapy cycle; | — |
Secondary
| Measure | Time frame |
|---|---|
| The time required for neutrophil recovery from the nadir to a count of 2.0 × 10^9/L or higher;The duration of grade 4 neutropenia; The lowest neutrophil count observed during each cycle; The incidence of grade 3/4 febrile neutropenia (FN);The incidence of hospitalizations attributable to neutropenia;The proportion of chemotherapy doses that were either reduced or delayed; The rate of antibiotic usage;The incidence of adverse reactions; | — |
Countries
China
Contacts
Public ContactXue Tang
West China Second University Hospital, Sichuan University
Outcome results
None listed