Status:
COMPLETED
Dose Finding Study of KRN125 (Pegfilgrastim) for Treatment of Neutropenic Patients
Lead Sponsor:
Kyowa Kirin Co., Ltd.
Conditions:
Neutropenia
Eligibility:
All Genders
20-74 years
Phase:
PHASE2
Brief Summary
To assess the duration of severe neutropenia in cycle 1 of chemotherapy after treatment with a single injection of KRN125 or multiple daily injections of filgrastim.
Eligibility Criteria
Inclusion
- patients diagnosed as malignant lymphoma
- patients who were refractory to anthracycline or anthraquinone containing chemotherapy
- patients who are going to receive ESHAP or CHASE treatment regimen
- ECOG performance status =\< 2
- patients who have appropriate bone marrow, hepatic and renal functions
- written informed consent
Exclusion
- double cancer
- history of bone marrow transplantation or PBSCT
- more than 2 prior chemotherapy regimens
- primary hematologic disease such as myelodysplastic syndrome
- previous radiotherapy within 4 weeks of enrollment
- woman of childbearing potential who were either pregnant, breast feeding
- patients who participated in other clinical trials within the last 4 weeks of enrollment
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2008
Estimated Enrollment :
107 Patients enrolled
Trial Details
Trial ID
NCT00364468
Start Date
March 1 2006
End Date
March 1 2008
Last Update
March 3 2017
Active Locations (6)
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1
Tokai region
Aichi, Japan
2
Kyusyu region
Fukuoka, Nagasaki, Japan
3
Kanto region
Gunma, Saitama, Tokyo, Kanagawa, Japan
4
Hokkaido region
Hokkaido, Japan