Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:22 PM
Ignite Modification Date:
2025-12-24 @ 3:22 PM
NCT ID:
NCT06857292
Eligibility Criteria:
Inclusion Criteria:
* Patients with 14≤ age \< 18 years;
* Newly diagnosed patients with non-myeloid malignancies who are confirmed by histopathology or cytology to require intensive chemotherapy (first course of chemotherapy or second course of chemotherapy);
* Primary prevention (G-CSF 24 to 72 hours after the first use of chemotherapy agents with myelosuppression to prevent the occurrence of febrile neutropenia (FN)) or secondary prevention (if FN or dose-restricted neutropenia occurred in a patient during a previous chemotherapy cycle) is required. Prophylactic use of G-CSF can be considered for the next chemotherapy cycle.
Febrile neutropenia (FN) : Oral temperature \>38.3 ° C (axillary temperature \>38.1 ° C) or oral temperature \>38.0 ° C (axillary temperature \>37.8 ° C) with ANC\<0.5×10\^9/L for 2 consecutive measurements within 2 hours, or ANC is expected to decrease to \<0.5×10\^9/L within 48 hours.
* KPS score ≥50 or Lansky (LPS) score ≥50;
* Normal hematopoietic function of bone marrow (ANC≥1.5×10\^9/L, PLT≥80×10\^9 /L, Hb≥75g/L, WBC≥3.0×10\^9/L, and not exceeding the upper limit of normal value);
* Life expectancy of at least 6 months; ⑦ Obtain written informed consent.
Exclusion Criteria:
* Received any rhG-CSF within 3 weeks prior to study participation;
* Received any antibody coupling drug (ADC) drugs with potential blood toxicity within 3 weeks before participating in the study;
* Recipients of hematopoietic stem cell transplantation or organ transplantation;
* Clinical trials of other drugs were being conducted within 2 months before enrollment;
* There is no control of infection, body temperature ≥38℃; ⑥ Liver function test: total bilirubin (TBIL) alanine aminotransferase (ALT.) and aspartate aminotransferase (AST.) were more than 2.5 times the upper limit of normal value; ⑦ Renal function test: serum creatinine (Cr.) \> 1.5 times the upper limit of normal value; ⑧Other conditions considered by the researchers to be contraindications for this study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
14 Years
Maximum Age:
18 Years
Study:
NCT06857292
Study Brief:
Protocol Section:
NCT06857292