Lymphoma Clinical Trial
Official title:
A PHASE II TRIAL OF 2-CDA IN PREVIOUSLY TREATED OR UNTREATED PATIENTS WITH MANTLE CELL LYMPHOMA (MCL)
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing
so they stop growing or die.
PURPOSE: Phase II trial to study the effects of cladribine in previously treated or
untreated patients with mantle cell lymphoma.
OBJECTIVES: I. Determine the efficacy of cladribine (2-chlorodeoxyadenosine; 2-CdA) as
treatment for mantle cell lymphoma (MCL) either as initial therapy or for
relapsed/refractory disease. II. Determine by flow cytometry immunophenotyping of blood
lymphocytes the number of patients with peripheral blood involvement at the time of
diagnosis and compare the presence or absence of peripheral blood involvement with response
data. III. Detect rearrangements involving the bcl-1 gene and immunoglobulin heavy chain
locus by molecular techniques (e.g., polymerase chain reaction, Southern blotting, or in
situ hybridization), and compare these results with immunohistochemical demonstration of
bcl-1 protein expression. VI. Determine the proliferative rate of MCL by
immunohistochemistry and DNA content flow cytometry. V. Summarize the toxic effects
associated with this treatment.
OUTLINE: Patients receive cladribine (2-chlorodeoxyadenosine; 2-CdA) daily for 5 days every
4 weeks for a maximum of 6 courses; response is assessed after every 2 courses. Patients in
complete remission or with stable disease discontinue treatment and are followed; those with
disease progression at any time are removed from study. Patients are followed every 2 months
for 1 year, every 4 months for 1 year, every 6 months for 1 year, and annually for 2 years.
;
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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