Clinical trial NCT04547829: Safety and Efficacy of PEG-rhG-CSF in Preventing Neutropenia in Children With Tumor After Chemotherapy
Official title: Safety and Efficacy of Pegylated Recombinant Human Granulocyte-colony Stimulating Factor(PEG-rhG-CSF) in Preventing Neutropenia in Children With Tumor After Chemotherapy：A Multi-center, Single Arm Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Pediatric Cancer
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2020-09-14
Enrollment: 108
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose is to evaluate the safety of PEG-rhG-CSF in the prevention of neutropenia in children with tumor after chemotherapy, and then evaluate the effectiveness of PEG-rhG-CSF in preventing neutropenia in children with tumor after chemotherapy.

Detailed description: The dosage was determined according to the patient's weight, 100 UG / kg each time; The method of administration: subcutaneous injection; The time of administration: 24-48 hours after the end of chemotherapy, once in each chemotherapy cycle.

Eligibility criteria: Inclusion Criteria:

- 1)6 years \< age \< 18 years old, regardless of gender; 2)Tumor patients diagnosed by histopathology or bone marrow cytology; 3)Patients who have not been treated for the first time; 4)ECoG score ≤ 2; 5)The expected survival time is more than 8 months; 6)The hematopoietic function of bone marrow was normal (ANC ≥ 1.5 × 109 / L, PLT ≥ 80 × 109 / L, Hb ≥ 75 g / L, WBC ≥ 3.0 × 109 / L); 7)Receive high-intensity chemotherapy, such as scccg lymphoma, CAV / ie, VIP regimen, etc., and expect bone marrow suppression of grade III or above after chemotherapy.

8)Patient's parent or guardian signs informed consent.

Exclusion Criteria:

* Patients with any of the following items will not be enrolled in this study:

  1. Local or systemic infection without adequate control;
  2. Severe visceral dysfunction;
  3. Liver function test: total bilirubin (TBIL), alanine aminotransferase (ALT), aspartate aminotransferase (AST) were all higher than 2.5 times of the upper limit of normal value; if due to liver metastasis, the above indicators were more than 5 times of the upper limit of normal value; renal function test: Serum creatinine (CR) \> 2 times of the upper limit of normal value;
  4. Those who took the same kind of other tested drugs or accepted clinical trials of other drugs within 4 weeks before enrollment;
  5. Allergic to peg-rhG-CSF, rhG-CSF and other preparations or proteins expressed by Escherichia coli;
  6. Serious mental illness, affecting informed consent and / or expression or observation of adverse reactions;
  7. The researcher judged the patients who were not suitable to participate.

Primary outcomes:
measure: safety of PEG-rhG-CSF in the prevention of neutropenia in children with tumor after chemotherapy
timeFrame: From the beginning of observation to the end of observation（6 weeks) of the last enrolled patient
Secondary outcomes:
measure: To evaluate the effectiveness of PEG-rhG-CSF in preventing neutropenia in children with tumor after chemotherapy.
timeFrame: From the beginning of observation to the end of observation（6 weeks) of the last enrolled patient
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center,
state: Guangdong
Study officials:
affiliation: Sun Yat-sen University CancerCenter
name: Yizhuo Zhang
role: PRINCIPAL_INVESTIGATOR
References: