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 Company, Limited
ClinicalTrials.gov Identifier:
NCT00364468
First received: August 14, 2006
Last updated: August 23, 2012
Last verified: August 2012

August 14, 2006
August 23, 2012
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
Not Provided
Not Provided
Not Provided
Not Provided
 
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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Neutropenia
Drug: pegfilgrastim
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
107
Not Provided
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
Both
20 Years to 74 Years
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT00364468
KRN125/05-A04
Not Provided
Kyowa Hakko Kirin Company, Limited
Kyowa Hakko Kirin Company, Limited
Not Provided
Study Chair: Tomomitsu Hotta, MD Nagoya Medical Center
Kyowa Hakko Kirin Company, Limited
August 2012

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