Pegfilgrastim Administered on the Same Day as Chemotherapy in Non-Hodgkin's Lymphoma
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|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|
- Reduce the duration of neutropenia and incidence of febrile neutropenia. [ Time Frame: The primary outcome will be evaluated at the end of the study. ] [ Designated as safety issue: Yes ]
- 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. ] [ Designated as safety issue: Yes ]
|Study Start Date:||February 2003|
|Study Completion Date:||August 2005|
|Primary Completion Date:||August 2005 (Final data collection date for primary outcome measure)|
Active Comparator: Arm A
pegfilgrastim 6 mg on day 1 of each cycle (within 4 hours of chemotherapy completion)
Active Comparator: Arm B
pegfilgrastim 6 mg on day 2 of each cycle (at least 24 hours after chemotherapy completion)
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).