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

Neutropenia Clinical Trial

Official title:

A Randomized Dose Finding Study of KRN125 (Pegfilgrastim) for the Treatment of Chemotherapy - Induced Neutropenia in Malignant Lymphoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00364468
• Other study ID #: KRN125/05-A04
• Status: Completed
• Phase: Phase 2
• First received: August 14, 2006
• Last updated: February 28, 2017
• Start date: March 2006
• Est. completion date: March 2008

Study information

• Verified date: February 2017
• Source: Kyowa Hakko Kirin Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 107
• Est. completion date: March 2008
• Est. primary completion date: March 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 74 Years

Eligibility

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

Related Conditions & MeSH terms

• Neutropenia

Intervention

Drug:
• pegfilgrastim

Locations

Country	Name	City	State
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

Sponsors (1)

Lead Sponsor	Collaborator
Kyowa Hakko Kirin Co., Ltd

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To compare the duration of severe neutropenia