Pegfilgrastim Administered on the Same Day as Chemotherapy in Non-Hodgkin's Lymphoma
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
1 other identifier
interventional
77
0 countries
N/A
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Feb 2003
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2003
CompletedFirst Submitted
Initial submission to the registry
June 21, 2005
CompletedFirst Posted
Study publicly available on registry
June 22, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2005
CompletedAugust 29, 2013
August 1, 2013
2.5 years
June 21, 2005
August 27, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Reduce the duration of neutropenia and incidence of febrile neutropenia.
The primary outcome will be evaluated at the end of the study.
Secondary Outcomes (1)
On the same day as chemotherapy as measured by the incidence of hematologic and non-hematologic toxicities, the number of subjects who received planned doses of chemotherapy on time and response rates.
The secondary outcome will be evaluated at the end of the study.
Study Arms (2)
Arm A
ACTIVE COMPARATORPegfilgrastim
Arm B
ACTIVE COMPARATORPegfilgrastim
Interventions
pegfilgrastim 6 mg on day 1 of each cycle (within 4 hours of chemotherapy completion)
Eligibility Criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Amgenlead
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
MD
Amgen
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 21, 2005
First Posted
June 22, 2005
Study Start
February 1, 2003
Primary Completion
August 1, 2005
Study Completion
August 1, 2005
Last Updated
August 29, 2013
Record last verified: 2013-08