Ignite Creation Date:
2025-12-24 @ 9:30 PM
Ignite Modification Date:
2026-01-01 @ 6:55 PM
Study NCT ID:
NCT00566332
Status:
COMPLETED
Last Update Posted:
2015-08-19
First Post:
2007-11-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Trial Comparing Chlorambucil to Fludarabine in Patients With Advanced Waldenström Macroglobulinemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008258', 'term': 'Waldenstrom Macroglobulinemia'}, {'id': 'D018442', 'term': 'Lymphoma, B-Cell, Marginal Zone'}], 'ancestors': [{'id': 'D054219', 'term': 'Neoplasms, Plasma Cell'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D020141', 'term': 'Hemostatic Disorders'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010265', 'term': 'Paraproteinemias'}, {'id': 'D001796', 'term': 'Blood Protein Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D006474', 'term': 'Hemorrhagic Disorders'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D016393', 'term': 'Lymphoma, B-Cell'}, {'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'id': 'D008223', 'term': 'Lymphoma'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002699', 'term': 'Chlorambucil'}, {'id': 'C024352', 'term': 'fludarabine'}], 'ancestors': [{'id': 'D009588', 'term': 'Nitrogen Mustard Compounds'}, {'id': 'D009150', 'term': 'Mustard Compounds'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 414}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-08', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-08-18', 'studyFirstSubmitDate': '2007-11-30', 'studyFirstSubmitQcDate': '2007-11-30', 'lastUpdatePostDateStruct': {'date': '2015-08-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-12-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patient overall response', 'timeFrame': 'At the end of treatment whether 6 or 12 months'}], 'secondaryOutcomes': [{'measure': 'Biological study', 'timeFrame': 'Whether 6 or 12 months'}, {'measure': 'Quality of life', 'timeFrame': 'Whether 6 or 12 months'}, {'measure': 'Response duration', 'timeFrame': '60 months'}, {'measure': 'Treatment toxicity', 'timeFrame': '60 months'}, {'measure': 'Event free survival', 'timeFrame': '60 months'}, {'measure': 'Overall survival', 'timeFrame': '60 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Waldenström Macroglobulinemia', 'Lymphoplasmacytic lymphoma', 'Splenic Marginal Zone Lymphoma', 'Fludarabine', 'Chlorambucil'], 'conditions': ['Waldenström Macroglobulinemia', 'Lymphoplasmacytic Lymphoma', 'Splenic Marginal Zone Lymphoma']}, 'referencesModule': {'references': [{'pmid': '23233721', 'type': 'DERIVED', 'citation': 'Leblond V, Johnson S, Chevret S, Copplestone A, Rule S, Tournilhac O, Seymour JF, Patmore RD, Wright D, Morel P, Dilhuydy MS, Willoughby S, Dartigeas C, Malphettes M, Royer B, Ewings M, Pratt G, Lejeune J, Nguyen-Khac F, Choquet S, Owen RG. Results of a randomized trial of chlorambucil versus fludarabine for patients with untreated Waldenstrom macroglobulinemia, marginal zone lymphoma, or lymphoplasmacytic lymphoma. J Clin Oncol. 2013 Jan 20;31(3):301-7. doi: 10.1200/JCO.2012.44.7920. Epub 2012 Dec 10.'}, {'pmid': '23065509', 'type': 'DERIVED', 'citation': "Nguyen-Khac F, Lambert J, Chapiro E, Grelier A, Mould S, Barin C, Daudignon A, Gachard N, Struski S, Henry C, Penther D, Mossafa H, Andrieux J, Eclache V, Bilhou-Nabera C, Luquet I, Terre C, Baranger L, Mugneret F, Chiesa J, Mozziconacci MJ, Callet-Bauchu E, Veronese L, Blons H, Owen R, Lejeune J, Chevret S, Merle-Beral H, Leblondon V; Groupe Francais d'Etude de la Leucemie Lymphoide Chronique et Maladie de Waldenstrom (GFCLL/MW); Groupe Ouest-Est d'etude des Leucemie Aigues et Autres Maladies du Sang (GOELAMS); Groupe d'Etude des Lymphomes de l'Adulte (GELA). Chromosomal aberrations and their prognostic value in a series of 174 untreated patients with Waldenstrom's macroglobulinemia. Haematologica. 2013 Apr;98(4):649-54. doi: 10.3324/haematol.2012.070458. Epub 2012 Oct 12."}]}, 'descriptionModule': {'briefSummary': "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.\n\nThe 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\n\nThis 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.\n\nThe 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).\n\nThe 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\nEstablished diagnosis of Waldenström macroglobulinemia (the 2nd Workshop on Waldenstrom's macroglobulinemia) or Lymphoplasmacytic lymphoma or Splenic Marginal Zone Lymphoma, needing a treatment\n\n* Life expectancy \\> 6 months\n* Creatinine \\< 200 µmol/l\n* SGPT and SGOT \\< 2x ULN\n* A negative direct Coombs test\n* Written informed consent\n\nExclusion Criteria:\n\n* Past chemotherapy/radiotherapy/immunotherapy prior to the study for Waldenström macroglobulinemia\n* Previous malignancy less than 5 years ago except carcinoma in situ of the cervix and non-melanoma skin cancer\n* Positive HIV serology\n* Active Hepatitis B or C\n* Lactation/pregnancy\n* Impossible good compliance with the study protocol\n* Active infection not controlled\n* Psychological condition hampering understanding of the study\n* Transformation into large B cell lymphoma\n* Peripheral neuropathy \\> grade II"}, 'identificationModule': {'nctId': 'NCT00566332', 'briefTitle': 'Trial Comparing Chlorambucil to Fludarabine in Patients With Advanced Waldenström Macroglobulinemia', 'organization': {'class': 'NETWORK', 'fullName': 'French Study Group on Chronic Lymphoid Leukemia'}, 'officialTitle': 'Randomized Trial Comparing the Efficacy of Chlorambucil to Fludarabine in Patients With Advanced Waldenström Macroglobulinemia,Lymphoplasmacytic Lymphoma or Splenic Marginal Zone Lymphoma', 'orgStudyIdInfo': {'id': 'WM1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'Chlorambucil 8mg/m² (6 mg/m² if patient aged more than 75 years old) 10 days every 28 days during 12 months', 'interventionNames': ['Drug: Chlorambucil']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'Fludarabine', 'interventionNames': ['Drug: Fludarabine']}], 'interventions': [{'name': 'Chlorambucil', 'type': 'DRUG', 'description': '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', 'armGroupLabels': ['1']}, {'name': 'Fludarabine', 'type': 'DRUG', 'description': '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', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75013', 'city': 'Paris', 'country': 'France', 'facility': "Hôpital La Pitié-Salpêtrière. 47-83 Bd de l'hôpital", 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'Véronique LEBLOND, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'French Study Group on Chronic Lymphoid Leukemia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'French Study Group on Chronic Lymphoid Leukemia', 'class': 'NETWORK'}, 'collaborators': [{'name': 'Lymphoma Study Association', 'class': 'OTHER'}, {'name': 'French Innovative Leukemia Organisation', 'class': 'OTHER'}, {'name': 'Département de Biostatistiques et Informatique Médicale DBIM', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}