A Study of PEG-rhG-CSF and rhG-CSF Used for Aplastic Anemia Granulocyte Deficiency

Not Applicable

Recruiting

• Conditions: Severe Aplastic Anemia
• Interventions: Drug: PEG-rhG-CSF

• Registration Number: NCT05531279
• Lead Sponsor: Institute of Hematology & Blood Diseases Hospital, China

Brief Summary

This study was a single-center,open-label,randomized,dose-exploring prospective study.Patients with granulocytotic aplastic anemia who received cytokine treatment with PEG-rhG-CSF or rhG-CSF were enrolled.Clinical demographic data,disease characteristics of aplastic anemia,clinical diagnosis and treatment,laboratory data and adverse events were collected to explore the dose and safety of PEG-rhG-CSF and rhG-CSF in patients with severe aplastic anemia.

Detailed Description

This study was a single-center,open-label,randomized,dose-exploring prospective study.Patients with granulocytotic aplastic anemia who received cytokine treatment with PEG-rhG-CSF or rhG-CSF were enrolled.Clinical demographic data,disease characteristics of aplastic anemia,clinical diagnosis and treatment,laboratory data and adverse events were collected to explore the dose and safety of PEG-rhG-CSF and rhG-CSF in patients with severe aplastic anemia.Research objectives: To explore the reasonable injection frequency of long-acting PEG-rhG-CSF in the adjuvant treatment of aplastic anemia patients with granulocytosis through a single center prospective clinical study.Disease classification of aplastic anemia: a total of 45 cases of SAA/VSAA with ANC\<0.5×109/L were stratified and randomized into three groups according to the radio of 1:1:1(15 cases in each group).PEG-rhG-CSF group A(q7d):6mg d1,8,subcutaneously injected;PEG-rhG-CSF group B(q10d):6mg d1,11,subcutaneously injected;RhG-CSF group(short-acting ): 480ug d1-14(daily for 14days),subcutaneously injected.Dose/protocol adjustment: after monitoring ANC\>0.5×109/L,the drug was stopped,and then ANC\<0.5×109/L was temporarily supplemented with one dose of the original group of drugs.

Study Timeline

• Study Start: 2022-06-05
• Status Verified: 2022-09
• Study First Submitted: 2022-09-02
• Study First Submitted QC: 2022-09-02
• Study First Posted: 2022-09-07
• Last Update Submitted: 2022-09-22
• Last Update Posted: 2022-09-26
• Primary Completion: 2025-06-05
• Study Completion: 2026-01-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

1. Age 18-70 years old, male or female, or weight≥50kg.
2. Patients with severe or very severe aplastic anemia of absolute neutrophil value< 0.5×109/L
3. ECOG score ≤ 2 points.
4. Normal renal function.

Exclusion Criteria

1. Patients with clonal chromosomal abnormalities.
2. Patients with previous malignant tumors.
3. Patients with severe or uncontrolled infectious diseases and /or bleeding.
4. Patients with AIDS or syphilis positive.
5. Severe organ dysfunction.
6. Patients used GM/G-CSF,PEG-rhG-CSF,interleukin-11 within 2 weeks before admission.
7. Allergic to G-CSF or PEG-rhG-CSF related components.
8. Participated in other clinical trials within 6 months.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PEG-rhG-CSF group A	PEG-rhG-CSF	PEG-rhG-CSF group A(q7d):6mg d1,8,subcutaneously injected,after monitoring ANC\>0.5×109/L,the drug was stopped,and then ANC\<0.5×109/L was temporarily supplemented with one dose of the same drug.
PEG-rhG-CSF group B	PEG-rhG-CSF	PEG-rhG-CSF group B(q10d):6mg d1,11,subcutaneously injected,after monitoring ANC\>0.5×109/L,the drug was stopped,and then ANC\<0.5×109/L was temporarily supplemented with one dose of the same drug.
rhG-CSF group(short-acting )	PEG-rhG-CSF	rhG-CSF group(short-acting ): 480ug d1-14(daily for 14days),subcutaneously injected.After monitoring ANC\>0.5×109/L,the drug was stopped,and then ANC\<0.5×109/L was temporarily supplemented with one dose of the same drug.

Primary Outcome Measures

Name	Time	Method
total number of effective (ANC>0.5×109/L) days	2 weeks	total number of effective (ANC\>0.5×109/L) days during 2 weeks of treatment(cases×days).

Trial Locations

Locations (1)

Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences; 🇨🇳 Tianjin, Tianjin, China