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Multi-center, open, one-arm clinical study evaluates the efficacy and safety of pegfegistim in preventing neutropenia in elderly patients with lymphoma after chemotherapy

Multi-center, open, one-arm clinical study evaluates the efficacy and safety of pegfegistim in preventing neutropenia in elderly patients with lymphoma after chemotherapy

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1900021514
Enrollment
Unknown
Registered
2019-02-25
Start date
2019-02-22
Completion date
Unknown
Last updated
2019-03-04

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

Conditions

Senile lymphoma

Interventions

Case series:The first cycle of chemotherapy, subcutaneous injection of pegfilgrasim 24-72 hours after the end of chemotherapy

Sponsors

Sun Yat-sen University Cancer Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
65 Years to No maximum

Inclusion criteria

Inclusion criteria: (1) Aged = 65 years male and female; (2) Patients with lymphoma diagnosed by histopathology or cytology; (3) Patients requiring multi-cycle chemotherapy; (4) Planned chemotherapy regimen FN risk = 20 %, or 10% <FN risk < 20% with high risk factors for at least one FN ; (5) Physical status (KPS) score = 70 points; (6) The expected survival time is more than 3 months; (7) The bone marrow hematopoietic function is normal (ANC =1.5×10^9/L, PLT=100×10^9/L, Hb=80g/L, WBC=3.0×10^9/L); (8) Subjects (or their legal representatives/guardians) must sign an informed consent form.

Exclusion criteria

Exclusion criteria: (1) lymphoma central involvement; (2) those who have undergone hematopoietic stem cell transplantation or organ transplantation; (3) local or systemic infections that are not adequately controlled; (4) severe visceral dysfunction and have occurred in the last 6 months Myocardial infarction; (5) liver function tests total bilirubin (TBIL), alanine aminotransferase (ALT), aspartate aminotransferase (AST) are > 2.5 times the upper limit of normal, if due to liver metastasis, the above indicators > 5 times Upper limit of normal value; renal function test: serum creatinine (Cr) > 2 times normal upper limit; (6) allergic to PEG-rhG-CSF, rhG-CSF and other preparations or proteins expressed by Escherichia coli; (7) Severe mental illness affects informed consent and/or adverse reaction presentation or observation; (8) The investigator judges patients who are not suitable for participation.

Design outcomes

Primary

MeasureTime frame
Incidence of neutropenic fever (FN) in each cycle of chemotherapy;

Secondary

MeasureTime frame
Incidence of IV degree ANC reduction in each chemotherapy cycle;Incidence of dose adjustment of chemotherapy drugs in each chemotherapy cycle;Incidence of chemotherapy delays in each chemotherapy cycle;Proportion of patients receiving antibiotics during the entire chemotherapy period;Occurrence and severity of adverse reactions;

Countries

China

Contacts

Public ContactHuiqiang Huang

Sun Yat-sen University Cancer Hospital

huanghq@sysucc.org.cn+86 13808885154

Outcome results

None listed

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