Trial Comparing Chlorambucil to Fludarabine in Patients With Advanced Waldenström Macroglobulinemia
Recruitment status was Recruiting
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Purpose
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 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Randomized Trial Comparing the Efficacy of Chlorambucil to Fludarabine in Patients With Advanced Waldenström Macroglobulinemia,Lymphoplasmacytic Lymphoma or Splenic Marginal Zone Lymphoma |
- Patient overall response [ Time Frame: At the end of treatment whether 6 or 12 months ] [ Designated as safety issue: Yes ]
- Biological study [ Time Frame: Whether 6 or 12 months ] [ Designated as safety issue: No ]
- Quality of life [ Time Frame: Whether 6 or 12 months ] [ Designated as safety issue: No ]
- Response duration [ Time Frame: 60 months ] [ Designated as safety issue: Yes ]
- Treatment toxicity [ Time Frame: 60 months ] [ Designated as safety issue: Yes ]
- Event free survival [ Time Frame: 60 months ] [ Designated as safety issue: Yes ]
- Overall survival [ Time Frame: 60 months ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 366 |
| Study Start Date: | June 2001 |
| Estimated Study Completion Date: | December 2008 |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 1
Chlorambucil 8mg/m² (6 mg/m² if patient aged more than 75 years old) 10 days every 28 days during 12 months
|
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
|
|
Active Comparator: 2
Fludarabine
|
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
|
Eligibility| 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
- 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
Contacts and Locations| 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 | |
| Principal Investigator: | Véronique LEBLOND, Professor | French Study Group on Chronic Lymphoid Leukemia |
More Information
No publications provided by French Study Group on Chronic Lymphoid Leukemia
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Pr Véronique LEBLOND, French Study Group on Chronic Lymphoid Leukemia |
| ClinicalTrials.gov Identifier: | NCT00566332 History of Changes |
| Other Study ID Numbers: | WM1 |
| Study First Received: | November 30, 2007 |
| Last Updated: | November 30, 2007 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Keywords provided by French Study Group on Chronic Lymphoid Leukemia:
|
Waldenström Macroglobulinemia Lymphoplasmacytic lymphoma Splenic Marginal Zone Lymphoma Fludarabine Chlorambucil |
Additional relevant MeSH terms:
|
Lymphoma Waldenstrom Macroglobulinemia Lymphoma, B-Cell, Marginal Zone Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Neoplasms, Plasma Cell Hemostatic Disorders Vascular Diseases Cardiovascular Diseases Paraproteinemias Blood Protein Disorders |
Hematologic Diseases Hemorrhagic Disorders Lymphoma, B-Cell Lymphoma, Non-Hodgkin Chlorambucil Fludarabine Fludarabine monophosphate Vidarabine Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Immunosuppressive Agents |
ClinicalTrials.gov processed this record on May 19, 2013