Splenic Marginal Zone Lymphoma Clinical Trial
Official title:
Randomized Trial Comparing the Efficacy of Chlorambucil to Fludarabine in Patients With Advanced Waldenström Macroglobulinemia,Lymphoplasmacytic Lymphoma or Splenic Marginal Zone Lymphoma
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.
Status | Completed |
Enrollment | 414 |
Est. completion date | December 2014 |
Est. primary completion date | September 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: Established diagnosis of Waldenström macroglobulinemia (the 2nd Workshop on Waldenstrom's macroglobulinemia) or Lymphoplasmacytic lymphoma or Splenic Marginal Zone Lymphoma, needing a treatment - Life expectancy > 6 months - Creatinine < 200 µmol/l - SGPT and SGOT < 2x ULN - A negative direct Coombs test - Written informed consent Exclusion Criteria: - Past chemotherapy/radiotherapy/immunotherapy prior to the study for Waldenström macroglobulinemia - Previous malignancy less than 5 years ago except carcinoma in situ of the cervix and non-melanoma skin cancer - Positive HIV serology - Active Hepatitis B or C - Lactation/pregnancy - Impossible good compliance with the study protocol - Active infection not controlled - Psychological condition hampering understanding of the study - Transformation into large B cell lymphoma - Peripheral neuropathy > grade II |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
France | Hôpital La Pitié-Salpêtrière. 47-83 Bd de l'hôpital | Paris |
Lead Sponsor | Collaborator |
---|---|
French Study Group on Chronic Lymphoid Leukemia | Département de Biostatistiques et Informatique Médicale DBIM, Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang GOELAMS, Lymphoma Study Association |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Patient overall response | At the end of treatment whether 6 or 12 months | Yes | |
Secondary | Biological study | Whether 6 or 12 months | No | |
Secondary | Quality of life | Whether 6 or 12 months | No | |
Secondary | Response duration | 60 months | Yes | |
Secondary | Treatment toxicity | 60 months | Yes | |
Secondary | Event free survival | 60 months | Yes | |
Secondary | Overall survival | 60 months | Yes |
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