KCT0002244
Recruiting
未知
A phase I clinical trial to investigate the safety, tolerability, and pharmacokinetics/pharmacodynamics of Tripegfilgrastim after single administration in pediatric solid tumor/lymphoma patients
Dong-A ST0 sites32 target enrollmentTBD
ConditionsNeoplasms
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Neoplasms
- Sponsor
- Dong-A ST
- Enrollment
- 32
- Status
- Recruiting
- Last Updated
- 7 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\>\=6 and \<19 year\-old pediatrics with solid tumor/lymphoma • Scheduled for chemotherapy requiring G\-CSF support or having given an experience of ANC\> \< 0\.5 x 10^9/L
- •ANC \> 0\.75 x 10^9/L, platelet \> 75 x 10^9/L
- •ECOG performance status 0 or 1
Exclusion Criteria
- •Patients with leukemia, myelodysplastic syndrome or uncontrolled infectious/nervous diseases
- •History of allergy to filgrastim, pegfilgrastim or known hypersensitivity to E\-coli derived proteins
- •Women who are pregnant or lactating
Outcomes
Primary Outcomes
Not specified
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