Clinical trial · Interventional
PEG-rhG-CSF in Patients With Non-Hodgkin Lymphoma Receiving Chemotherapy to Prevent Neutropenia
NCT02996617CI-TRIAL-00025216unknownPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- 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)
Neutropenia is one of the most frequent adverse effects of chemotherapy, and the main factor to limit the dosage and the continuation of chemotherapy. The PEG-rhG-CSF has increased plasma half-life, and prolonged efficacy in compare with rhG-CSF. The purpose of this study is to determine the safety and effectiveness of PEG-rhG-CSF in preventing neutropenia following chemotherapy in patients with non-Hodgkin lymphoma.
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 |
|---|---|---|---|
| Lymphoma,Non-Hodgkin | Non-Hodgkin Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Pegylated rhG-CSF regimen | Drug | — | UNRESOLVED |
| rhG-CSF regimen | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- rhG-CSF regimen
- description
- Patients weren't preventive use of rhG-CSF（ruibai 100ug）.If their WBC≤1×10\^ 9/L,they were administered rhG-CSF:5ug/kg/day until their WBC≥4×10\^ 9/L for total 4 courses.
- interventionNames
- Drug: rhG-CSF regimen
- type
- EXPERIMENTAL
- label
- Pegylated rhG-CSF regimen
- description
- Patients were administered pegylated rhG-CSF 6mg（weight≥45Kg）or 3mg（weight≤45Kg）once 24 hours after the end of chemotherapy drugs of every chemotherapy cycle for total 4 courses.
- interventionNames
- Drug: Pegylated rhG-CSF regimen
Primary outcomes (1)
- measure
- Rate of grade 3/4 neutropenia（neutrophils≤1×10^ 9/L） in every cycle
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Investigator diagnosis of non-Hodgkin lymphoma(Highly invasive lymphoma/Burkitt lymphoma were excluded) * Age 18 to 80 years * ECOG performance status ≤ 2 * receive multi-cycle Chemotherapy naive * grade 3/4 neutropenia occurred in the patient's first cycle chemotherapy or the risk of neutropenia \>20% without rhG-CSF support * Expected survival time≥3 months; cNormal bone marrow function(absolute neutrophil count ≥1.5 × 109/L; platelet count ≥ 80 × 109/L) * Liver function: transaminase≤2.5× upper limit of normal value，bilirubin≤2.5×upper limit of normal value; serum creatinine≤2×upper limit of normal value; Exclusion Criteria: * Patients with severe complications or severe infection; * Invasion of central nervous system; * Patients with severe visceral organ dysfunction, heart block, myocardial infarction within 6 months; * Prior bone marrow stem cell or organ transplantation * patients with severe allergic constitution, or those who are allergic to Escherichia coli products; 5. Patients participate in other clinical studies within 4 weeks; * Pregnancy, lactation * Other patients who are not suitable for the study.
References
Publications (7)
- BACKGROUNDGreen MD, Koelbl H, Baselga J, Galid A, Guillem V, Gascon P, Siena S, Lalisang RI, Samonigg H, Clemens MR, Zani V, Liang BC, Renwick J, Piccart MJ; International Pegfilgrastim 749 Study Group. A randomized double-blind multicenter phase III study of fixed-dose single-administration pegfilgrastim versus daily filgrastim in patients receiving myelosuppressive chemotherapy. Ann Oncol. 2003 Jan;14(1):29-35. doi: 10.1093/annonc/mdg019. PMID 12488289
- BACKGROUNDHolmes FA, Jones SE, O'Shaughnessy J, Vukelja S, George T, Savin M, Richards D, Glaspy J, Meza L, Cohen G, Dhami M, Budman DR, Hackett J, Brassard M, Yang BB, Liang BC. Comparable efficacy and safety profiles of once-per-cycle pegfilgrastim and daily injection filgrastim in chemotherapy-induced neutropenia: a multicenter dose-finding study in women with breast cancer. Ann Oncol. 2002 Jun;13(6):903-9. doi: 10.1093/annonc/mdf130. PMID 12123336
- BACKGROUNDJohnston E, Crawford J, Blackwell S, Bjurstrom T, Lockbaum P, Roskos L, Yang BB, Gardner S, Miller-Messana MA, Shoemaker D, Garst J, Schwab G. Randomized, dose-escalation study of SD/01 compared with daily filgrastim in patients receiving chemotherapy. J Clin Oncol. 2000 Jul;18(13):2522-8. doi: 10.1200/JCO.2000.18.13.2522. PMID 10893282
- BACKGROUNDHadji P, Kostev K, Schroder-Bernhardi D, Ziller V. Cost comparison of outpatient treatment with granulocyte colony-stimulating factors (G-CSF) in Germany. Int J Clin Pharmacol Ther. 2012 Apr;50(4):281-9. doi: 10.5414/cp201633. PMID 22456299
- BACKGROUNDWen TJ, Wen YW, Chien CR, Chiang SC, Hsu WW, Shen LJ, Hsiao FY. Cost-effectiveness of granulocyte colony-stimulating factor prophylaxis in chemotherapy-induced febrile neutropenia among breast cancer and Non-Hodgkin's lymphoma patients under Taiwan's national health insurance system. J Eval Clin Pract. 2017 Apr;23(2):288-293. doi: 10.1111/jep.12597. Epub 2016 Aug 4. PMID 27491287
- BACKGROUNDShi YK, Chen Q, Zhu YZ, He XH, Wang HQ, Jiang ZF, Chang JH, Liu YP, Wang AL, Luo DY, Zhang Y, Ke XY, Li WL, Zhang WJ, Wang XW, Zhang YP, Wang JM, Liu XQ. Pegylated filgrastim is comparable with filgrastim as support for commonly used chemotherapy regimens: a multicenter, randomized, crossover phase 3 study. Anticancer Drugs. 2013 Jul;24(6):641-7. doi: 10.1097/CAD.0b013e3283610b5d.