Overview

Pegfilgrastim Administered on the Same Day as Chemotherapy in Non-Hodgkin's Lymphoma

Status:
Completed
Trial end date:
2005-08-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to provide data on the safety and efficacy of pegfilgrastim when administered on the same day versus the next day of chemotherapy, as measured by the duration of grade 4 neutropenia.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Amgen
Criteria
Inclusion Criteria: - Histologically proven mantle cell lymphoma or histologically proven
diffuse large B-cell non-Hodgkin's lymphoma (NHL) according to the REAL classification -
Measurable and/or evaluable disease - Previously untreated patients Exclusion Criteria: -
Burkitt's or B-lymphoblastic lymphoma - Central nervous system (CNS) involvement - Active
infection requiring treatment with systemic anti-infectives within 72 hours of chemotherapy
- Prior malignancy within the last 5 years - T-cell lymphoma or history of indolent
lymphoma - Prior bone marrow or stem cell transplantation - Known sensitivity to E. coli
derived drug products