Dose Finding Study of KRN125 (Pegfilgrastim) for Treatment of Neutropenic Patients
NCT ID: NCT00364468
Last Updated: 2017-03-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
107 participants
INTERVENTIONAL
2006-03-31
2008-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Interventions
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pegfilgrastim
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
20 Years
74 Years
ALL
No
Sponsors
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Kyowa Kirin Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Tomomitsu Hotta, MD
Role: STUDY_CHAIR
Nagoya Medical Center
Locations
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Tokai region
Aichi, , Japan
Kyusyu region
Fukuoka, Nagasaki, , Japan
Kanto region
Gunma, Saitama, Tokyo, Kanagawa, , Japan
Hokkaido region
Hokkaido, , Japan
Kinki region
Kyoto, Mie, Shiga, , Japan
Tohoku region
Miyagi, , Japan
Countries
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Other Identifiers
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KRN125/05-A04
Identifier Type: -
Identifier Source: org_study_id
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