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Spots Global Cancer Trial Database for Pegfilgrastim Administered on the Same Day as Chemotherapy in Non-Hodgkin's Lymphoma

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Trial Identification

Brief Title: Pegfilgrastim Administered on the Same Day as Chemotherapy in Non-Hodgkin's Lymphoma

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 ID: NCT00115193

Study Description

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.

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).

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Contact Details

Name: MD

Affiliation: Amgen

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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