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Trial Comparing Chlorambucil to Fludarabine in Patients With Advanced Waldenström Macroglobulinemia

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2007 by French Study Group on Chronic Lymphoid Leukemia.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Lymphoma Study Association
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
First received: November 30, 2007
Last updated: NA
Last verified: November 2007
History: No changes posted
  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

Resource links provided by NLM:


Further study details as provided by French Study Group on Chronic Lymphoid Leukemia:

Primary Outcome Measures:
  • Patient overall response [ Time Frame: At the end of treatment whether 6 or 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00566332

Contacts
Contact: Véronique LEBLOND, Professor 33 1 42 16 28 24 veronique.leblond@psl.aphp.fr

Locations
France
Hôpital La Pitié-Salpêtrière. 47-83 Bd de l'hôpital Recruiting
Paris, France, 75013
Principal Investigator: Véronique LEBLOND, Professor         
Sponsors and Collaborators
French Study Group on Chronic Lymphoid Leukemia
Lymphoma Study Association
Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang GOELAMS
Département de Biostatistiques et Informatique Médicale DBIM
Investigators
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:
Waldenstrom Macroglobulinemia
Lymphoma
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 July 23, 2014