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PEG-rhG-CSF in Patients With Lymphoma Receiving Chemotherapy

The Multi-center,Open-label,Single Arm Clinical Trial of Efficacy and Safety of PEG-rhG-CSF in Patients With Lymphoma Receiving Chemotherapy

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02805218
Enrollment
410
Registered
2016-06-17
Start date
2013-09-30
Completion date
2016-02-29
Last updated
2016-06-20

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

Conditions

Lymphoma

Brief summary

The purpose of this study is to estimate the safety and efficacy of PEG-rhG-CSF in patients with lymphoma receiving chemotherapy.

Interventions

DRUGPEG-rhG-CSF

Sponsors

CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.
Lead SponsorINDUSTRY

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patients with age ≥ 18 years * diagnosis of lymphoma(Hodgkin's lymphoma and non-Hodgkin's lymphoma) patients * Karnofsky Performance Status Z70 * life expectancy of at least 8 months * normal white blood cell count and platelet count * Written informed consent are acquired

Exclusion criteria

* uncontrolled infection * pregnancy * Have accepted any other anti-tumor drug within 4 weeks before anticipated the study * Other situations that investigators consider as contra-indication for this study

Design outcomes

Primary

MeasureTime frame
The occurrence rate of adverse eventup to 30 days after the patient study completion
The severity of adverse eventup to 30 days after the patient study completion

Secondary

MeasureTime frame
the occurrence rate of grade III/ IV neutropenia during chemotherapy cyclesthrough the study completion,an average of 5 months

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026