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

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Randomized,Open-label Dose-discovery Study of PEG-rhG-CSF and rhG-CSF in the Adjuvant Therapy of Aplastic Anemia Granulocyte Deficiency

Conditions
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Severe Aplastic Anemia

Intervention / Treatment
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* Drug: PEG-rhG-CSF


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18-70 years old, male or female, or weight≥50kg. Patients with severe or very severe aplastic anemia of absolute neutrophil value< 0.5×109/L ECOG score ≤ 2 points. Normal renal function. Exclusion Criteria: Patients with clonal chromosomal abnormalities. Patients with previous malignant tumors. Patients with severe or uncontrolled infectious diseases and /or bleeding. Patients with AIDS or syphilis positive. Severe organ dysfunction. Patients used GM/G-CSF,PEG-rhG-CSF,interleukin-11 within 2 weeks before admission. Allergic to G-CSF or PEG-rhG-CSF related components. Participated in other clinical trials within 6 months.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PEG-rhG-CSF group A<br>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. | Drug: PEG-rhG-CSF<br>* 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.<br>* Other names: rhG-CSF;|
| Experimental: PEG-rhG-CSF group B<br>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. | Drug: PEG-rhG-CSF<br>* 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.<br>* Other names: rhG-CSF;|
| Experimental: rhG-CSF group(short-acting )<br>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. | Drug: PEG-rhG-CSF<br>* 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.<br>* Other names: rhG-CSF;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| total number of effective (ANC>0.5×109/L) days | total number of effective (ANC>0.5×109/L) days during 2 weeks of treatment(cases×days). | 2 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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G-CSF