Lymphoma Clinical Trial
Official title:
Phase II Study of Pentostatin With Cyclophosphamide and Rituximab for Previously Untreated Patients With Chronic Lymphocytic Leukemia
RATIONALE: Pentostatin may stop the growth of cancer cells by blocking some of the enzymes
needed for cell growth. Drugs used in chemotherapy, such as cyclophosphamide, work in
different ways to stop the growth of cancer cells, either by killing the cells or by
stopping them from dividing. Monoclonal antibodies, such as rituximab, can block cancer
growth in different ways. Some block the ability of cancer cells to grow and spread. Others
find cancer cells and help kill them or carry cancer-killing substances to them. Giving
pentostatin together with cyclophosphamide and rituximab may kill more cancer cells.
PURPOSE: This phase II trial is studying the side effects and how well giving pentostatin
together with cyclophosphamide and rituximab works in treating patients with previously
untreated chronic lymphocytic leukemia.
OBJECTIVES:
- To determine the frequency of response in patients with previously untreated,
intermediate- or high-risk B-cell chronic lymphocytic leukemia (CLL) treated with
pentostatin, cyclophosphamide, and rituximab.
- To characterize the toxicity of this regimen in these patients.
OUTLINE: Patients receive cyclophosphamide IV followed by pentostatin IV on day 1 in course
1. Beginning in course 2 and in all subsequent courses, patients receive cyclophosphamide IV
on day 1, pentostatin IV on day 1, and rituximab IV on day 1 or on days 1 and 2. Treatment
repeats every 3 weeks for up to 6 courses in the absence of disease progression or
unacceptable toxicity.
After completion of study treatment, patients are followed at least every 3 months for 1
year.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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