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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00364468
First Posted: August 15, 2006
Last Update Posted: March 3, 2017
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.
Information provided by (Responsible Party):
Kyowa Hakko Kirin Co., Ltd
  Purpose
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 Intervention Phase
Neutropenia Drug: pegfilgrastim Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Kyowa Hakko Kirin Co., Ltd:

Primary Outcome Measures:
  • To compare the duration of severe neutropenia

Enrollment: 107
Study Start Date: March 2006
Study Completion Date: March 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
  Eligibility

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
Criteria

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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00364468


Locations
Japan
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
Investigators
Study Chair: Tomomitsu Hotta, MD Nagoya Medical Center
  More Information

Responsible Party: Kyowa Hakko Kirin Co., Ltd
ClinicalTrials.gov Identifier: NCT00364468     History of Changes
Other Study ID Numbers: KRN125/05-A04
First Submitted: August 14, 2006
First Posted: August 15, 2006
Last Update Posted: March 3, 2017
Last Verified: February 2017

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

Additional relevant MeSH terms:
Neutropenia
Agranulocytosis
Leukopenia
Leukocyte Disorders
Hematologic Diseases