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

Phase 2

Completed

• Conditions: Neutropenia

• Registration Number: NCT00364468
• Lead Sponsor: Kyowa 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-03
• Study First Submitted: 2006-08-14
• Study First Submitted QC: 2006-08-14
• Study First Posted: 2006-08-15
• Primary Completion: 2008-03
• Study Completion: 2008-03
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-28
• Last Update Posted: 2017-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 107

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
To compare the duration of severe neutropenia

Trial Locations

Locations (6)

Kyusyu region; 🇯🇵 Fukuoka, Nagasaki, Japan

Tokai region; 🇯🇵 Aichi, Japan

Kanto region; 🇯🇵 Gunma, Saitama, Tokyo, Kanagawa, Japan

Hokkaido region; 🇯🇵 Hokkaido, Japan

Tohoku region; 🇯🇵 Miyagi, Japan

Kinki region; 🇯🇵 Kyoto, Mie, Shiga, Japan