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

• Status: Completed
• Trial end date: 2008-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kyowa Hakko Kirin Company, Limited; Kyowa Kirin Co., Ltd.

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