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Dose Finding Study of KRN125 (Pegfilgrastim) for Treatment of Neutropenic Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kyowa Hakko Kirin Co., Ltd
ClinicalTrials.gov Identifier:
NCT00364468
First received: August 14, 2006
Last updated: February 28, 2017
Last verified: February 2017

August 14, 2006
February 28, 2017
March 2006
March 2008   (Final data collection date for primary outcome measure)
To compare the duration of severe neutropenia
Same as current
Complete list of historical versions of study NCT00364468 on ClinicalTrials.gov Archive Site
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Dose Finding Study of KRN125 (Pegfilgrastim) for Treatment of Neutropenic Patients
A Randomized Dose Finding Study of KRN125 (Pegfilgrastim) for the Treatment of Chemotherapy - Induced Neutropenia in Malignant Lymphoma
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Treatment
Neutropenia
Drug: pegfilgrastim
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
107
March 2008
March 2008   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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 Criteria:

  • 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
Sexes Eligible for Study: All
20 Years to 74 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
 
NCT00364468
KRN125/05-A04
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Kyowa Hakko Kirin Co., Ltd
Kyowa Hakko Kirin Co., Ltd
Not Provided
Study Chair: Tomomitsu Hotta, MD Nagoya Medical Center
Kyowa Hakko Kirin Co., Ltd
February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP