Randomized Phase II Study About the Application of Pegfilgrastim (Neulasta) at Day 2 or Day 4 Within the Treatment in Patients With Aggressive Non-Hodgkin's Lymphoma Aged 61 to 80 Years With 6 or 8 Cycles of Chemotherapy With CHOP (Cyclophosphamide, Doxorubicin, Vincristine and Prednisone) at 14-day Intervals (CHOP-14), Both With or Without the Monoclonal Anti-CD20 Antibody Rituximab
- Determine the side effects of pegfilgrastim and cyclophosphamide, doxorubicin
hydrochloride, vincristine, and prednisone (CHOP) with or without rituximab in older
patients with aggressive B-cell non-Hodgkin lymphoma.
- Determine adherence to therapy regimens in these patients.
- Determine antitumor effectivity of immunochemotherapy.
OUTLINE: This is a multicenter study.
All patients receive prephase treatment comprising vincristine on day -6 and prednisone on
days -6 to 0. Patients are then randomized to 1 of 2 treatment arms.
- Arm I (without rituximab): Patients receive pegfilgrastim subcutaneously (SC) on day 2
or 4 and CHOP comprising cyclophosphamide IV, doxorubicin hydrochloride IV, and
vincristine IV on day 1, and oral prednisone on days 1-5. Treatment repeats every 2
weeks for up to 6-8 courses in the absence of disease progression or unacceptable
- Arm II (with rituximab): Patients receive pegfilgrastim and CHOP for up to 6-8 courses
as in arm I. They also receive rituximab (administered 2 hours before beginning CHOP)
on day 1. Treatment with rituximab repeats every 2 weeks for up to 8 courses.
Patients with bulky disease or extranodal disease also undergo radiotherapy.
Allocation: Randomized, Primary Purpose: Treatment
Frank Hartmann, MD
Universitaetsklinikum des Saarlandes
United States: Federal Government