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

Kyowa Kirin

Status and phase: Completed; Phase 2

Conditions: Neutropenia

Treatments: Drug: pegfilgrastim

Study type: Interventional

Funder types: Industry

Identifiers

NCT00364468

KRN125/05-A04

Details and patient eligibility

About

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.

Enrollment: 107 patients

Sex: All

Ages: 20 to 74 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)