Rituximab, Bendamustine and Lenalidomide in Patients With Aggressive B-cell Lymphoma Not Eligible for High Dose Chemotherapy or Anthracycline-Based Therapy. A Phase I/II Trial.
- To determine the maximum-tolerated dose of the combination of rituximab, bendamustine
hydrochloride, and lenalidomide in patients with aggressive B-cell lymphoma not
eligible for anthracycline-based first-line treatment or intensive regimens including
high-dose therapy (HDT) followed by autologous stem cell transplantation (ASCT) in
refractory or relapsing disease, or as treatment for patients relapsing after HDT with
ASCT. (phase I).
- To identify the recommended dose of this regimen for a phase II study (phase I).
- To determine the efficacy and safety of this regimen in these patients (phase II).
- To assess the quality of life (QOL) of patients treated with this regimen (phase II).
- To evaluate the usefulness and feasibility of the SAKK Cancer-Specific Geriatric
Assessment (C-SGA) in patients treated with this regimen (phase II).
- To assess the association between WHO performance status, QOL indicators, and SAKK
C-SGA scores (phase II).
- To describe changes in SAKK C-SGA scores from pre- to post-treatment and in QOL (phase
OUTLINE: This is a multicenter, phase I dose-escalation study of bendamustine hydrochloride
and lenalidomide followed by a phase II study.
Patients receive rituximab IV on day 1, bendamustine hydrochloride IV over 30-60 minutes on
days 1-2, and oral lenalidomide on days 1-21. Courses repeat every 28 days for up to 6
courses in the absence of disease progression or unacceptable toxicity.
Patients on phase II study complete the SAKK Cancer-Specific Geriatric Assessment at
baseline and after completion of course 1. Patients also complete quality-of-life
questionnaires at baseline and periodically during study.
After completion of study therapy, patients are followed for up to 2 years.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Dose-limiting toxicity (phase I)
at 4 weeks.
Felicitas Hitz, MD
Kantonsspital St. Gallen