Lymphoma Clinical Trial
Official title:
A Randomised Trial of Chlorambucil Versus Fludarabine as Initial Therapy of Waldenström's Macroglobulinaemia and Splenic Lymphoma With Villous Lymphocytes
RATIONALE: Drugs used in chemotherapy, such as chlorambucil and fludarabine, work in
different ways to stop the growth of cancer cells, either by killing the cells or by
stopping them from dividing. It is not yet known whether chlorambucil is more effective than
fludarabine in treating Waldenström macroglobulinemia, splenic lymphoma, or
lymphoplasmacytic lymphoma.
PURPOSE: This randomized phase III trial is studying chlorambucil to see how well it works
compared with fludarabine as first-line therapy in treating patients with previously
untreated Waldenström macroglobulinemia, splenic lymphoma, or lymphoplasmacytic lymphoma.
OBJECTIVES:
- Compare the efficacy of first-line therapy comprising chlorambucil vs fludarabine
phosphate in patients with previously untreated Waldenström macroglobulinemia, splenic
lymphoma with villous lymphocytes, or non-IgM lymphoplasmacytic lymphoma.
OUTLINE: This is a multicenter study. Patients are stratified according to disease
(Waldenström macroglobulinemia vs splenic lymphoma with villous lymphocytes vs non-IgM
lymphoplasmacytic lymphoma). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive oral chlorambucil on days 1-10. Treatment repeats every 28 days
for up to 12 courses in the absence of disease progression or unacceptable toxicity.
- Arm II: Patients receive fludarabine phosphate orally or IV on days 1-5. Treatment
repeats every 28 days for 3-6 courses in the absence of disease progression or
unacceptable toxicity.
Patients undergo quality of life assessment at baseline.
;
Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
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