Phase I/II Study of Vorinostat (SAHA), Cladribine, and Rituximab (SCR) in Mantle Cell Lymphoma, Chronic Lymphocytic Leukemia, and Relapsed B Cell Non-Hodgkin's Lymphoma
- To determine the maximum tolerated dose of vorinostat when administered in combination
with cladribine and rituximab in patients with mantle cell lymphoma, chronic
lymphocytic leukemia (CLL), or relapsed B-cell non-Hodgkin lymphoma (NHL).
- To determine the response rate in patients treated with this regimen.
- To determine the safety and efficacy of this regimen in these patients.
- To determine the progression-free survival of patients treated with this regimen.
- To determine the overall survival of patients treated with this regimen.
- To collect blood samples for genetic testing to help understand how NHL and CLL are
affected by vorinostat alone and by vorinostat in combination with cladribine and
OUTLINE: This is a phase I, dose-escalation study of vorinostat followed by a phase II
- Phase I: Patients receive oral vorinostat on days 1-14 and cladribine on days 1-5.
Patients also receive rituximab on days 3, 10, 17, and 24 of course 1 and on day 3 of
all subsequent courses. Treatment repeats every 28 days for up to 6 courses in the
absence of disease progression or unacceptable toxicity.
- Phase II: Patients receive vorinostat (at the maximum tolerated dose determined in
phase I), cladribine, and rituximab as in phase I.
Blood samples are collected periodically for laboratory studies.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum tolerated dose of vorinostat
Daily on days 1-14
Stephen Spurgeon, MD
OHSU Knight Cancer Institute
United States: Institutional Review Board
|OHSU Knight Cancer Institute||Portland, Oregon 97239|
|Penn State Hershey Cancer Institute||Hershey, Pennsylvania 17033|