Phase I/II Trial of Maintenance Therapy With Lenalidomide and Rituximab Following High-Dose Chemotherapy and Autologous Stem Cell Transplantation for B-cell Non-Hodgkin Lymphoma
The study was originally intended to be Phase I/Phase II but it terminated early because of
toxicity of treatment and therefore never moved to the Phase II portion of the study.
PRIMARY OBJECTIVES: I. To establish the maximum tolerated dose (MTD) and safety of
lenalidomide in combination with rituximab in subjects with B-cell NHL following ASCT.
(Phase I) II. To evaluate the tolerability of maintenance therapy with lenalidomide and
rituximab after ASCT in subjects with B-cell NHL. (Phase II)
SECONDARY OBJECTIVES: I. To evaluate the progression-free survival of subjects with B-cell
NHL receiving maintenance therapy with lenalidomide and rituximab after ASCT. II. To
examine whether potential effects of lenalidomide and rituximab on progression-free survival
after ASCT, compared with historical controls, vary according to histologic subtype of
B-cell NHL. III. To correlate potential associations between peripheral blood levels of
lymphocyte subsets including NK, T, and B cells and progression-free survival after ASCT in
enrolled subjects. IV. To evaluate potential associations between progression-free survival
after ASCT and polymorphisms at position 158 of FCgammaRIIIa receptor in enrolled subjects.
OUTLINE: Patients receive oral lenalidomide once daily on days 1-21of all courses and
rituximab IV on day 1of courses 1, 3, 5, 7, 9, and 11. Treatment repeats every 28 days for
up to 12 courses in the absence of disease progression or unacceptable toxicity. After
completion of study treatment, patients are followed periodically for 2 years.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum tolerated dose of lenalidomide (Phase I)
Robert Dean, MD
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
United States: Food and Drug Administration
|Hillcrest Hospital Cancer Center||Mayfield Heights, Ohio 44124|
|Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center||Cleveland, Ohio 44195|
|Fairview Cancer Hospital||Cleveland, Ohio 44111|