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| Sponsored by: |
Amgen |
| Information provided by: | Amgen |
| ClinicalTrials.gov Identifier: | NCT00115193 |
Purpose
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.
| Condition | Intervention | Phase |
|
Non-Hodgkin's Lymphoma |
Drug: pegfilgrastim |
Phase II |
| MedlinePlus related topics: | Lymphoma |
| Drug Information available for: | Pegfilgrastim |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Single Group Assignment, Bio-availability Study |
| Official Title: | 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 |
| Study Start Date: | February 2003 |
| Estimated Study Completion Date: | September 2005 |
Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
More Information
AmgenTrials clinical trials website 
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| Responsible Party: | Amgen Inc. ( Global Development Leader ) |
| Study ID Numbers: | 20020134 |
| First Received: | June 21, 2005 |
| Last Updated: | December 20, 2007 |
| ClinicalTrials.gov Identifier: | NCT00115193 |
| Health Authority: | United States: Food and Drug Administration |
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