Clinical trial · Interventional
Evaluate the Efficacy and Safety of PEG-rhG-CSF in Preventing Neutropenia After Chemotherapy in Patients With Non-Hodgkin's Lymphoma
A Multi-center, Open-label, Single-arm Study to Evaluate the Efficacy and Safety of PEG-rhG-CSF(Jinyouli®) in Preventing Neutropenia After Chemotherapy in Patients With Non-Hodgkin's Lymphoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The main treatments for non-Hodgkin's lymphoma are surgery, radiotherapy, chemotherapy, and bone marrow transplantation. Neutropenia is the most common and serious complication of most chemotherapy. This study is a multi-center, open-label, single-arm clinical study to evaluate the efficacy and safety of jinyouli in preventing neutropenia in patients with non Hodgkin's lymphoma after chemotherapy.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non Hodgkin's Lymphoma | Non-Hodgkin Lymphoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PEG-rhG-CSF | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- PEG-rhG-CSF group
- description
- Patients received subcutaneous injection of PEG-rhG-CSF(Jinyouli®) 48 hours after the end of chemotherapy, 6mg for patients with body weight≥45kg and 3mg for patients with body weight less than 45kg, once per chemotherapy cycle
- interventionNames
- Drug: PEG-rhG-CSF
Primary outcomes (1)
- measure
- The incidence of grade Ⅲ/Ⅳ neutropenia
- timeFrame
- From date of randomization until the date of the study completion,up to 24 weeks
- description
- Grade Ⅲ neutropenia is defined as ANC≥0.5×10\^9/L, and \<1×10\^9/L; Grade Ⅳ neutropenia is defined as ANC\<0.5×10\^9/L
Secondary outcomes (3)
- measure
- Incidence of febrile neutropenia (FN)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age ≥ 18 years, gender is not limited; 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 ; According to the judgment of the investigator, there is a risk of FN occurrence if G-CSF support is not accepted, PEG-rhG-CSF should be used prophylactically from the first cycle; 5. Physical status (KPS) score ≥ 70 points; 6. Expected Survival period of more than 3 months; 7. Normal bone marrow hematopoietic function (ANC ≥1.5×10\^9/L, PLT≥80×10\^9/L, Hb≥75g/L, WBC≥3.0×10\^9/L); 8. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST)≤2.5 times the upper limit of normal value, or≤5 times the upper limit of normal value when there is liver metastasis; total bilirubin (TBIL)≤2.5 times the upper limit of normal value; serum creatinine (Cr)≤2 times the upper limit of normal value; 9. Female patients of childbearing age must be negative in urine pregnancy test before treatment; 10. The testers (or their legal representatives/guardians) must sign an informed consent form. Exclusion Criteria: 1. Lymphoma central involvement; 2. Hematopoietic stem cell transplantation or organ transplantation; 3. Local or systemic infection without adequate control; 4. Severe internal organ dysfunction and occurred in the last 6 months Myocardial infarction; 5. Those who used other test drugs of the same kind or accepted other clinical trials within 4 weeks before enrollmen; 6. Allergy to PEG-rhG-CSF, rhG-CSF and other preparations or proteins expressed by Escherichia coli; 7. Severe mental illness, affecting informed consent and/or adverse reaction expression or observation; 8. Pregnant or lactating female patients; women who refuse to accept contraceptive measures ; 9. Researchers determine unsuited to participate in this trial.
References
Publications (0)
Data not yet available