Trial Information
A Multicenter, Double-Blind, Randomized Study of Pegfilgrastim Administered on the Same Day or the Next Day of R-Chop Chemotherapy in Subjects With Non-Hodgkin's Lymphoma
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Outcome Measure:
Reduce the duration of neutropenia and incidence of febrile neutropenia.
Principal Investigator
MD
Investigator Role:
Study Director
Investigator Affiliation:
Amgen
Authority:
United States: Food and Drug Administration
Study ID:
20020134
NCT ID:
NCT00115193
Start Date:
February 2003
Completion Date:
Related Keywords:
- Non-Hodgkin's Lymphoma
- Oncology
- NHL
- Mantle cell
- Diffuse large B-cell
- Chemotherapy
- RCHOP
- Neulasta®
- Neutropenia
- Pegfilgrastim
- Amgen
- Lymphoma
- Lymphoma, Non-Hodgkin