Lymphoma Clinical Trial
Official title:
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)
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing
so they stop growing or die. Monoclonal antibodies such as rituximab can locate cancer cells
and either kill them or deliver cancer-killing substances to them without harming normal
cells. Combining chemotherapy with monoclonal antibody therapy may kill more cancer cells.
PURPOSE: Phase II trial to study the effectiveness of combining pentostatin and rituximab in
treating patients who have non-Hodgkin's lymphoma or chronic lymphocytic leukemia.
OBJECTIVES:
- 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
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