- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00115193
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This was a multicenter, double-blind, randomized, phase 2 study of pegfilgrastim given either the same day as or the day after a chemotherapy regimen consisting of cyclophosphamide, doxorubicin, vincristine, prednisone, and rituximab (R-CHOP).
Chemotherapy was administered every 21 days for up to 6 cycles in subjects with aggressive non-Hodgkin's lymphoma (NHL; mantle cell or diffuse large B-cell lymphoma). Subjects were administered R-CHOP on day 1 of each cycle. All subjects were randomized to 1 of 2 treatment arms: arm A subjects were administered pegfilgrastim 6 mg on day 1 of each cycle (within 4 hours of chemotherapy completion); arm B subjects were administered pegfilgrastim 6 mg on day 2 of each cycle (at least 24 hours after chemotherapy completion). All subjects were administered placebo on the day they did not receive pegfilgrastim. A total of 77 subjects were enrolled at 24 centers across the US. Protocol treatment duration for subjects was up to 18 weeks (6 three-week cycles).
Study Type
Enrollment (Actual)
Phase
- Phase 2
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Arm A
Pegfilgrastim
|
pegfilgrastim 6 mg on day 1 of each cycle (within 4 hours of chemotherapy completion)
pegfilgrastim 6 mg on day 2 of each cycle (at least 24 hours after chemotherapy completion)
|
Active Comparator: Arm B
Pegfilgrastim
|
pegfilgrastim 6 mg on day 1 of each cycle (within 4 hours of chemotherapy completion)
pegfilgrastim 6 mg on day 2 of each cycle (at least 24 hours after chemotherapy completion)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Reduce the duration of neutropenia and incidence of febrile neutropenia.
Time Frame: The primary outcome will be evaluated at the end of the study.
|
The primary outcome will be evaluated at the end of the study.
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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.
Time Frame: The secondary outcome will be evaluated at the end of the study.
|
The secondary outcome will be evaluated at the end of the study.
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20020134
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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