Lymphoma Clinical Trial
Official title:
Phase II Trial of Rituximab and 2-Chlorodeoxyadenosine (2-CDA) in Newly Diagnosed Mantle Cell Lymphoma (MCL)
RATIONALE: Monoclonal antibodies such as rituximab can locate cancer cells and either kill
them or deliver cancer-killing substances to them without harming normal cells. Drugs used
in chemotherapy such as cladribine work in different ways to stop cancer cells from dividing
so they stop growing or die. Combining rituximab with cladribine may kill more cancer cells.
PURPOSE: This phase II trial is studying how well giving rituximab together with cladribine
works in treating patients with newly-diagnosed mantle cell lymphoma.
OBJECTIVES:
- Determine whether rituximab and cladribine will increase the complete remission rate
and the unconfirmed complete remission rate in patients with mantle cell lymphoma.
- Determine the time to progression in patients treated with this regimen.
- Determine the toxic effects of this regimen in these patients.
OUTLINE: This is a multicenter study.
An initial cohort of 6 patients at Mayo Clinic receives rituximab IV over 4-8 hours on day 1
and cladribine IV over 2 hours on days 4-8. If 2 or more patients experience unacceptable
toxicity during the first course, the study is discontinued; otherwise, the study is opened
for enrollment at all NCCTG sites. (The phase II study is open for enrollment as of
5/14/04.)
Treatment repeats every 28 days for a total of 2-6 courses in the absence of disease
progression or unacceptable toxicity.
Patients are followed every 2 months for 1 year, every 4 months for 1 year, every 6 months
for 1 year, and then annually for 2 years.
;
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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