Exploring treatments for severe aplastic anemia using PEG-rhG-CSF and rhG-CSF
A Randomized,Open-label Dose-discovery Study of PEG-rhG-CSF and rhG-CSF in the Adjuvant Therapy of Aplastic Anemia Granulocyte Deficiency
This study is testing whether a long-acting or short-acting treatment can help people with severe aplastic anemia improve their low white blood cell counts.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 45 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Institute of Hematology & Blood Diseases Hospital, China Academic / other |
| Locations | 1 site (Tianjin, Tianjin) |
| Trial ID | NCT05531279 on ClinicalTrials.gov |
What this trial studies
This study investigates the safety and dosing of PEG-rhG-CSF and rhG-CSF in patients with severe aplastic anemia characterized by low neutrophil counts. It is a single-center, open-label, randomized, dose-exploring prospective study that enrolls patients to receive either long-acting PEG-rhG-CSF or short-acting rhG-CSF. Clinical data, including demographics, disease characteristics, and adverse events, are collected to evaluate the effectiveness of these treatments. The goal is to determine the optimal injection frequency for PEG-rhG-CSF in treating granulocytotic aplastic anemia.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-70 with severe or very severe aplastic anemia and low absolute neutrophil counts.
Not a fit: Patients with clonal chromosomal abnormalities, previous malignancies, or severe organ dysfunction may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective treatment option for patients suffering from severe aplastic anemia.
How similar studies have performed: While this approach is being explored, similar studies have shown promise in using G-CSF for treating neutropenia, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Tianjin, Tianjin
- Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences — Tianjin, Tianjin, China (Recruiting)
Study contacts
- Study coordinator: Fengkui Zhang, Doctor
- Email: fkzhang@ihcams.ac.cn
- Phone: +862223909229
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.