Severe Aplastic Anemia
Conditions
Keywords
G-CSF
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.
Interventions
DRUGPEG-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.
Sponsors
Institute of Hematology & Blood Diseases Hospital, China
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Countries
China
Contacts
Primary ContactFengkui Zhang, Doctor
Backup ContactHuihui Fan, Doctor
Outcome results
None listed