Safety and Efficacy of PEG-rhG-CSF in Preventing Neutropenia in Children With Tumor After Chemotherapy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

108 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-10

Study Completion Date

2023-05-10

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Pediatric Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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PEG-rhG-CSF

pegylated recombinant human granulocyte-colony stimulating factor subcutaneous injection

Group Type EXPERIMENTAL

pegylated recombinant human granulocyte-colony stimulating factor

Intervention Type DRUG

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.

Interventions

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pegylated recombinant human granulocyte-colony stimulating factor

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.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

6 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No