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

Severe Aplastic Anemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05531279
• Other study ID #: IIT2021022-EC-1
• Status: Recruiting
• Phase: N/A
• Start date: June 5, 2022
• Est. completion date: January 5, 2026

Study information

• Verified date: September 2022
• Source: Institute of Hematology & Blood Diseases Hospital
• Contact: Fengkui Zhang, Doctor
• Phone: +862223909229
• Email: fkzhang[@]ihcams.ac.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: January 5, 2026
• Est. primary completion date: June 5, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anemia
• Anemia, Aplastic
• Severe Aplastic Anemia

Intervention

Drug:
• PEG-rhG-CSF
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.

Locations

Country	Name	City	State
China	Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences	Tianjin	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Institute of Hematology & Blood Diseases Hospital

Country where clinical trial is conducted

China, 

References & Publications (1)

Tichelli A, Schrezenmeier H, Socié G, Marsh J, Bacigalupo A, Dührsen U, Franzke A, Hallek M, Thiel E, Wilhelm M, Höchsmann B, Barrois A, Champion K, Passweg JR. A randomized controlled study in patients with newly diagnosed severe aplastic anemia receivin — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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