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

Sponsor

Amgen (Industry)

Overall Status

Completed

CT.gov ID

NCT00115193

Collaborator

(none)

Enrollment

Arms

Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Non-Hodgkin's Lymphoma	Drug: pegfilgrastim Drug: pegfilgrastim	Phase 2

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 Design

Study Type:

Interventional

Actual Enrollment :

77 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

Quadruple (Participant, Care Provider, 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

Study Start Date :

Feb 1, 2003

Actual Primary Completion Date :

Aug 1, 2005

Actual Study Completion Date :

Aug 1, 2005

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Arm A Pegfilgrastim	Drug: pegfilgrastim pegfilgrastim 6 mg on day 1 of each cycle (within 4 hours of chemotherapy completion)
Active Comparator: Arm B Pegfilgrastim	Drug: pegfilgrastim pegfilgrastim 6 mg on day 2 of each cycle (at least 24 hours after chemotherapy completion)

Arm

Intervention/Treatment

Active Comparator: Arm A

Pegfilgrastim

Drug: pegfilgrastim

pegfilgrastim 6 mg on day 1 of each cycle (within 4 hours of chemotherapy completion)

Active Comparator: Arm B

Pegfilgrastim

Drug: pegfilgrastim

pegfilgrastim 6 mg on day 2 of each cycle (at least 24 hours after chemotherapy completion)

Outcome Measures

Primary Outcome Measures

Reduce the duration of neutropenia and incidence of febrile neutropenia. [The primary outcome will be evaluated at the end of the study.]

Secondary Outcome Measures

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.]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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