Phase II Multicenter Trial Of Pentostatin and Rituximab In Patients With Previously Treated and Untreated Low Grade B-Cell Non-Hodgkin's Lymphoma (NHL) Including Chronic Lymphocytic Leukemia (CLL)
- Determine the response rate in patients with low-grade B-cell non-Hodgkin's lymphoma or
chronic lymphocytic leukemia treated with pentostatin and rituximab.
- Determine the duration of response, median time to progression, and survival of
patients treated with this regimen.
- Determine the safety of this regimen in these patients.
OUTLINE: This is a multicenter study.
Patients receive rituximab IV alone on day 1 of course 1 only. Patients then receive
rituximab IV and pentostatin IV on days 8, 15, and 22. An additional course with both drugs
is administered on days 36, 43, and 50. Patients with progressive disease or a complete
response receive no further treatment. Patients with responsive disease, but less than a
complete response, receive one additional course of therapy as above.
Patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 50 non-Hodgkin's lymphoma and 50 chronic lymphocytic leukemia
patients will be accrued for this study.
Masking: Open Label, Primary Purpose: Treatment
United States: Federal Government
|Cancer and Blood Institute of the Desert||Rancho Mirage, California 92270|
|North Shore Hematology/Oncology Associates, P.C.||East Setauket, New York 11733|
|Oncology-Hematology Associates, P.A.||Clinton, Maryland 20735|
|Redding Medical Center||Redding, California 96001|
|Hematology Oncology Associates of Central New York, P.C.||Syracuse, New York 13210|