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

This study has been completed.

Sponsored by:	Kyowa Hakko Kirin Company, Limited
Information provided by:	Kyowa Hakko Kirin Company, Limited
ClinicalTrials.gov Identifier:	NCT00364468

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 II

MedlinePlus related topics: Lymphoma

Drug Information available for: Pegfilgrastim

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	A Randomized Dose Finding Study of KRN125 (Pegfilgrastim) for the Treatment of Chemotherapy - Induced Neutropenia in Malignant Lymphoma

Further study details as provided by Kyowa Hakko Kirin Company, Limited:

Primary Outcome Measures:

To compare the duration of severe neutropenia

Estimated Enrollment:	100
Study Start Date:	March 2006
Estimated Primary Completion Date:	August 2008 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	20 Years to 74 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00364468

Locations

Japan
Hokkaido region
Hokkaido, Japan
Tohoku region
Miyagi, Japan
Kanto region
Gunma, Saitama, Tokyo, Kanagawa, Japan
Tokai region
Aichi, Japan
Kyusyu region
Fukuoka, Nagasaki, Japan
Kinki region
Kyoto, Mie, Shiga, Japan

Sponsors and Collaborators

Kyowa Hakko Kirin Company, Limited

Investigators

Study Chair:

Tomomitsu Hotta, MD

Nagoya Medical Center

More Information

Study ID Numbers:	KRN125/05-A04
Study First Received:	August 14, 2006
Last Updated:	February 12, 2008
ClinicalTrials.gov Identifier:	NCT00364468
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by Kyowa Hakko Kirin Company, Limited:

pegfilgrastim
neutropenia
cancer patients
lymphoma

Study placed in the following topic categories:

Signs and Symptoms
Neutropenia
Hematologic Diseases
Agranulocytosis

Leukocyte Disorders
Leukopenia
Granulocytopenia
Lymphoma

ClinicalTrials.gov processed this record on January 16, 2009