A Phase II Randomized Study of Lenalidomide or Lenalidomide and Rituximab as Maintenance Therapy Following Standard Chemotherapy for Patients With High/High-intermediate Risk Diffuse Large B-Cell Lymphoma
- To assess the 1-year disease-free and relapse-free survival of patients with high- or
high/intermediate-risk diffuse large B-cell non-Hodgkin lymphoma treated with
maintenance therapy comprising lenalidomide with or without rituximab following
- To assess the 2-year disease-free survival of patients treated with these regimens.
- To define the safety and toxicity profile of these regimens.
- To perform antibody-dependent cellular cytotoxicity assays using peripheral blood
mononuclear cell samples from these patients.
- To assess the change in the number of natural killer cells by flow cytometric analysis.
- To evaluate cytokines including, but not limited to, sIL-2R, IL-6, IL-15, IL-12, TNF-α,
and IFN-γ in these patients.
- To study the KIR genotype receptor and FCγR polymorphisms.
OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive oral lenalidomide once daily on days 1-21. Treatment repeats
every 28 days for 12 courses in the absence of disease progression or unacceptable
- Arm II: Patients receive lenalidomide as in arm I and rituximab IV on day 8 of courses
1, 3, 5, 7, 9, and 11 in the absence of disease progression or unacceptable toxicity.
Peripheral blood mononuclear cells are collected periodically for correlative studies.
Samples are analyzed for change in the number of natural killer cells by flow cytometry;
antibody-dependent cellular cytotoxicity by assay; cytokines; KIR genotype receptor; and
After completion of study therapy, patients are followed at 30 days and then every 3 months
for 1 year.
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Disease-free survival at 1 year
1 year after completing treatment
Nishitha Reddy, MD
Vanderbilt-Ingram Cancer Center
United States: Food and Drug Administration
VICC HEM 0835
|Vanderbilt-Ingram Cancer Center||Nashville, Tennessee 37232-6838|
|Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill||Chapel Hill, North Carolina 27599-7570|
|Vanderbilt-Ingram Cancer Center - Cool Springs||Nashville, Tennessee 37064|
|Vanderbilt-Ingram Cancer Center at Franklin||Nashville, Tennessee 37064|