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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00364468
Recruitment Status : Completed
First Posted : August 15, 2006
Last Update Posted : March 3, 2017
Information provided by (Responsible Party):
Kyowa Hakko Kirin Co., Ltd

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.

Condition or disease Intervention/treatment Phase
Neutropenia Drug: pegfilgrastim Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 107 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Dose Finding Study of KRN125 (Pegfilgrastim) for the Treatment of Chemotherapy - Induced Neutropenia in Malignant Lymphoma
Study Start Date : March 2006
Actual Primary Completion Date : March 2008
Actual Study Completion Date : March 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. To compare the duration of severe neutropenia

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 74 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00364468

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
Sponsors and Collaborators
Kyowa Hakko Kirin Co., Ltd
Study Chair: Tomomitsu Hotta, MD Nagoya Medical Center

Responsible Party: Kyowa Hakko Kirin Co., Ltd Identifier: NCT00364468     History of Changes
Other Study ID Numbers: KRN125/05-A04
First Posted: August 15, 2006    Key Record Dates
Last Update Posted: March 3, 2017
Last Verified: February 2017

Keywords provided by Kyowa Hakko Kirin Co., Ltd:
cancer patients

Additional relevant MeSH terms:
Leukocyte Disorders
Hematologic Diseases