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Study on the Efficacy and Safety of Pegfilgrastim in Primary Prevention of Chemotherapy-induced Neutropenia in Non-Hodgkin Lymphoma

Study on the Efficacy and Safety of Pegfilgrastim in Primary Prevention of Chemotherapy-induced Neutropenia in Non-Hodgkin Lymphoma

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400087519
Enrollment
Unknown
Registered
2024-07-29
Start date
2024-07-30
Completion date
Unknown
Last updated
2024-08-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

non-Hodgkin lymphoma

Interventions

Primary Prevention Group:Subcutaneous injection of 2 mg of pegfilgrastim with in 24-48 hours after chemotherapy

Sponsors

Anqing Municipal Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Patients aged = 18 years; 2. Patients with non-Hodgkin lymphoma confirmed by histopathology or immunomolecular biology, starting from the first chemotherapy cycle, using chemotherapeutic drugs that suppress bone marrow, including: a.Patients receiving high-risk FN (febrile neutropenia) chemotherapy regimens; b. Patients receiving intermediate-risk FN chemotherapy regimens and having =1 individual risk factors; c.Patients undergoing curative or adjuvant chemotherapy to ensure full dosage of the treatment. 3.ECOG (Eastern Cooperative Oncology Group) performance status = 2; 4. Life expectancy of at least 8 months; 5. Written informed consent obtained.

Exclusion criteria

Exclusion criteria: 1. Patients currently participating in other drug clinical trials; 2.Patients who have previously received short-acting or other long-acting granulocyte colony-stimulating factor (G-CSF) treatments; 3.Patients receiving intermediate-risk FN (febrile neutropenia) chemotherapy regimens without any individual risk factors; 4. Patients undergoing low-risk FN chemotherapy regimens; 5.Patients with severe cardiac impairment (left ventricular ejection fraction EF 2.5 times the upper limit of normal; if due to liver metastasis, > 5 times the upper limit of normal; kidney function tests: serum creatinine (Cr) > 2 times the upper limit of normal; 7. Pregnant or breastfeeding female patients; 8. Other conditions that the researcher considers contraindications for this study.

Design outcomes

Primary

MeasureTime frame
Incidence of Grade 3-4 Neutropenia;

Countries

China

Contacts

Public ContactHaitao Xu

Hematology Department of Anqing Municipal Hospital

danielxu9@163.com+86 139 6663 5325

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026