Neutropenia
Conditions
Keywords
pegfilgrastim, neutropenia, cancer patients, lymphoma
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.
Interventions
DRUGpegfilgrastim
Sponsors
Kyowa Kirin Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 74 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the duration of severe neutropenia | — |
Countries
Japan
Outcome results
None listed