A Randomised Trial of Chlorambucil Versus Fludarabine as Initial Therapy of Waldenström's Macroglobulinaemia and Splenic Lymphoma With Villous Lymphocytes
- 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
Patients undergo quality of life assessment at baseline.
Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
Response to therapy (complete and partial response rates)
Roger G. Owen, MD, MRCP
Leeds Cancer Centre at St. James's University Hospital