Trial Comparing Chlorambucil to Fludarabine in Patients With Advanced Waldenström Macroglobulinemia
Status:
Completed
Trial end date:
2014-12-01
Target enrollment:
Participant gender:
Summary
Waldenström's macroglobulinaemia (WM) is a lymphoproliferative disorder characterized by a
monoclonal IgM paraprotein and morphological evidence of lymphoplasmacytic lymphoma: the
cells are IgM+, IgD+, CD19+ and CD20+ but usually CD5-, CD10- and CD23-. The treatment
efficacy is difficult to assess because of the lack of clear diagnostic criteria , good
response criteria, and of randomized trials.
The actual treatment is Chlorambucil, an alkylating agent. A purine analogue such as
Fludarabine has proven its efficacy on 30 % to 80 % as first line therapy
This study is a phase II b open, prospective, international multicenter trial (England, Dr
Johnson, Dr Catovsky, Australia: Dr Seymour) promoted by the French Cooperative Group on
Chronic Lymphoid Leukemia in untreated WM, or closely related disorders ( Lymphoplasmacytic
lymphoma or splenic marginal zone lymphoma). 366 patients must be included, among them 180
patients in France. Patients will be stratified according to the lymphoproliferative
disorder.
The patients will receive Chlorambucil by oral route for 10 days every 28 days (12 cycles) (8
MG/M², 6 MG/M² if patient is more than 75 years old) or Fludarabine by oral route for 5 days
every 28 days (6 cycles) (40MG/M², 30 MG/M² if patient is more than 75 years old).
The primary objective is to compare the efficacy (response rate) of Chlorambucil to
Fludarabine in previously untreated patients. The secondary objectives are the duration of
response, the improvement of hematological parameters, the toxicity, the quality of life, the
event free survival and the overall survival.
Phase:
Phase 3
Details
Lead Sponsor:
French Study Group on Chronic Lymphoid Leukemia
Collaborators:
Département de Biostatistiques et Informatique Médicale DBIM French Innovative Leukemia Organisation Lymphoma Study Association