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Sponsors and Collaborators: |
French Study Group on Chronic Lymphoid Leukemia Groupe d'Etudes des Lymphomes de l'Adulte GELA Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang GOELAMS Département de Biostatistiques et Informatique Médicale DBIM |
Information provided by: | French Study Group on Chronic Lymphoid Leukemia |
ClinicalTrials.gov Identifier: | NCT00566332 |
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.
Condition | Intervention | Phase |
Waldenström Macroglobulinemia Lymphoplasmacytic Lymphoma Splenic Marginal Zone Lymphoma |
Drug: Chlorambucil Drug: Fludarabine |
Phase III |
Genetics Home Reference related topics: | aceruloplasminemia hemophilia |
MedlinePlus related topics: | Leukemia, Adult Acute Leukemia, Adult Chronic Lymphoma |
ChemIDplus related topics: | Fludarabine Fludarabine monophosphate Chlorambucil |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Randomized Trial Comparing the Efficacy of Chlorambucil to Fludarabine in Patients With Advanced Waldenström Macroglobulinemia,Lymphoplasmacytic Lymphoma or Splenic Marginal Zone Lymphoma |
Estimated Enrollment: | 366 |
Study Start Date: | June 2001 |
Estimated Study Completion Date: | December 2008 |
Arms | Assigned Interventions |
1: Active Comparator
Chlorambucil 8mg/m² (6 mg/m² if patient aged more than 75 years old) 10 days every 28 days during 12 months
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Drug: Chlorambucil
Chlorambucil 8 mg/m² (6 mg/m² if patient aged more than 75 years old) 10 days every 28 days during 12 months By oral route
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2: Active Comparator
Fludarabine
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Drug: Fludarabine
Fludarabine 40 mg/m² (30 mg/m² if patient aged more than 75 years old) 5 days every 28 days during 6 cycles By oral route
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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
Exclusion Criteria:
Contact: Véronique LEBLOND, Professor | 33 1 42 16 28 24 | veronique.leblond@psl.aphp.fr |
France | |||||
Hôpital La Pitié-Salpêtrière. 47-83 Bd de l'hôpital | Recruiting | ||||
PARIS, France, 75013 | |||||
Principal Investigator: Véronique LEBLOND, Professor |
French Study Group on Chronic Lymphoid Leukemia |
Groupe d'Etudes des Lymphomes de l'Adulte GELA |
Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang GOELAMS |
Département de Biostatistiques et Informatique Médicale DBIM |
Principal Investigator: | Véronique LEBLOND, Professor | French Study Group on Chronic Lymphoid Leukemia |
Responsible Party: | French Study Group on Chronic Lymphoid Leukemia ( Pr Véronique LEBLOND ) |
Study ID Numbers: | WM1 |
First Received: | November 30, 2007 |
Last Updated: | November 30, 2007 |
ClinicalTrials.gov Identifier: | NCT00566332 |
Health Authority: | France: Afssaps - French Health Products Safety Agency |
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