Clinical trial · Interventional
A Study Comparing Pegylated Filgrastim and Filgrastim in Support for Chemotherapy
A Multicenter, Randomized, Cross-over Phase 3 Comparing Preventive Pegylated Filgrastim and Filgrastim in Cancer Patients Receiving Myelosuppressive Chemotherapy
- 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 delay the schedule of chemotherapy. Preventive filgrastim administration has long been established as the standard of care. A pegylated filgrastim was independently developed by GeneLeuk Biopharmaceutical Co., Ltd, Shandong, China. It composed of filgrastim and a 20 kd polyethylene glycol molecule covalently bound at the N-terminal residue. Preclinical studies phase 1 and phase 2 trials have shown that pegylated filgrastim has decreased renal clearance, increased plasma half-life, and prolonged efficacy in compare with filgrastim. These characters were similar to those of Neulasta. The investigators designed a multicenter, randomized, cross-over phase Ⅲ trial to compare the efficacy and safety of a single injection of pegylated filgrastim and daily injections of filgrastim in chemotherapy naive patients receiving commonly used regimens. The hypothesis is that pegylated filgrastim is similarly effective and safe with regular filgrastim.
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 |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| filgrastim and pegylated filgrastim | Drug | — | UNRESOLVED |
| pegylated filgrastim and filgrastim | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- AOB,pegylated filgrastim to filgrastim
- description
- patients were administered pegylated filgrastim 100 ug/kg in cycle 1 and filgrastim 5 ug/kg/d in cycle 2
- interventionNames
- Drug: pegylated filgrastim and filgrastim
- type
- ACTIVE_COMPARATOR
- label
- BOA,filgrastim to pegylated filgrastim
- description
- patients received filgrastim 5 ug/kg/d in cycle 1 and pegylated filgrastim 100 ug/kg in cycle 2
- interventionNames
- Drug: filgrastim and pegylated filgrastim
Primary outcomes (1)
- measure
- Protective rate of grade 4 neutropenia
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * diagnosis of malignant solid tumours (excluding highly aggressive lymphomas such as lymphoblastic lymphoma and Burkitt lymphoma) * chemotherapy naive * Karnofsky Performance Status ≥70 * age 18-70 years; normal white blood cell (WBC) count and platelet count * adequate renal, hepatic and cardiac function * life expectancy ≥3 months * normal bone marrow function Exclusion Criteria: * history of systematic chemotherapy (including adjuvant therapy) * large area radiotherapy (\>25% of bone marrow volume) * uncontrolled infection * bone marrow involvement * pregnancy, lactation * history of blood stem cell or organ transplantation * antibiotic administration within 72 hours of enrolment * long time exposure to glucocorticoids and immunosuppressive agents
References
Publications (1)
- DERIVEDYang S, He X, Liu P, Zhou S, Dong M, Qin Y, Yang J, Zhang C, Han X, Shi Y. [Duration of filgrastim prophylaxis for chemotherapy-induced neutropenia and its predictors]. Zhonghua Zhong Liu Za Zhi. 2016 Jan;38(1):69-72. doi: 10.3760/cma.j.issn.0253-3766.2016.01.013. Chinese. PMID 26796810