Randomized Trial of Chlorambucil Versus Chlorambucil Plus Rituximab Versus Rituximab in MALT Lymphoma
NCT ID: NCT00210353
Last Updated: 2019-06-06
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
454 participants
INTERVENTIONAL
2003-01-31
2016-02-17
Brief Summary
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In April 2006, a third arm of treatment was added to compare the antitumor activity and safety of rituximab alone vs chlorambucil alone
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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ARM A
chlorambucil 6 mg/m2 daily during the first 6 weeks of treatment; two weeks rest; chlorambucil 6 mg/m2 daily during the first two of a four weeks cycles (total of 4 cycles)
chlorambucil (drug)
chlorambucil 6 mg/m2 daily during the first 6 weeks of treatment, two weeks rest, chlorambucil 6 mg/m2 daily during the first two of a four weeks cycles (total of 4 cycles)
ARM B
rituximab 375 mg/m2 iv, d1, d8, d15, d22 chlorambucil 6 mg/m2 os, daily during the first 6 weeks of treatment two weeks rest chlorambucil 6 mg/m2 os daily during the first two of a four weeks cycles (total of 4 cycles) rituximab 375 mg/m2 iv at day 1 of each cycle
rituximab+chlorambucil
rituximab 375 mg/m2 iv, d1, 8, 15, 22, chlorambucil 6 mg/m2 os, daily during the first 6 weeks of treatment, ; two weeks rest; chlorambucil 6 mg/m2 os, daily during the first two of a four weeks cycles (total of 4 cycles) rituximab 375 mg/m2 iv at day 1 of each cycle
ARM C (Since April 2006)
rituximab 375 mg/m2 iv on days 1, 8, 15, 22, 56, 84, 112, 140
rituximab
rituximab 375 mg/m2 iv on days 1, 8, 15, 22, 56, 84, 112, 140
Interventions
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chlorambucil (drug)
chlorambucil 6 mg/m2 daily during the first 6 weeks of treatment, two weeks rest, chlorambucil 6 mg/m2 daily during the first two of a four weeks cycles (total of 4 cycles)
rituximab+chlorambucil
rituximab 375 mg/m2 iv, d1, 8, 15, 22, chlorambucil 6 mg/m2 os, daily during the first 6 weeks of treatment, ; two weeks rest; chlorambucil 6 mg/m2 os, daily during the first two of a four weeks cycles (total of 4 cycles) rituximab 375 mg/m2 iv at day 1 of each cycle
rituximab
rituximab 375 mg/m2 iv on days 1, 8, 15, 22, 56, 84, 112, 140
Eligibility Criteria
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Inclusion Criteria
2. any stage (Ann Arbor I-IV)
3. either de novo, or relapsed disease following local therapy (including surgery, radiotherapy and antibiotics for H. pylori-positive gastric lymphoma)
4. no evidence of histologic transformation to a high grade lymphoma
5. measurable or evaluable disease
6. age \> 18
7. life expectancy of at least 1 year
8. ECOG performance status 0-2
9. no prior diagnosis of neoplasm within 5 years, except cervical intraepithelial neoplasia type 1 (CIN1) or localized non-melanomatous skin cancer
10. no prior chemotherapy
11. no prior immunotherapy with any anti-CD20 monoclonal antibody
12. no prior radiotherapy in the last 6 weeks
13. no corticosteroids during the last 28 days, unless prednisone chronically administered at a dose \<20 mg/day for indications other than lymphoma or lymphoma-related symptoms
14. no evidence of clinically significant cardiac disease, as defined by history of symptomatic ventricular arrhythmias, congestive heart failure or myocardial infarction within 12 months before study entry
15. no evidence of symptomatic central nervous system (CNS) disease
16. no impairment of bone marrow function (WBC \>3.0x109/L, ANC \>1.5x109/L, PLT \>100x109/L), unless due to lymphoma involvement
17. no major impairment of renal function (serum creatinine \<1,5x upper normal) or liver function (ASAT/ALAT \<2,5 upper normal, total bilirubin \<2,5x upper normal), unless due to lymphoma involvement
18. no evidence of active opportunistic infections
19. no known HIV infection
20. no active HBV and/or HCV infection
21. no pregnant or lactating status
22. appropriate contraceptive method in women of childbearing potential or men
23. absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
24. informed consent must be given according to national/local regulations before randomization
18 Years
ALL
No
Sponsors
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International Extranodal Lymphoma Study Group (IELSG)
OTHER
Responsible Party
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Principal Investigators
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Emanuele Zucca, MD
Role: STUDY_CHAIR
International Extranodal Lymphoma Study Group/Oncology Institute of Southern Switzerland. Bellinzona
Emilio Montserrat, MD
Role: STUDY_CHAIR
Clinic Hospital Universitari, Hematology. Barcelona
Catherine Thieblemont, MD
Role: STUDY_CHAIR
Centre Hospitalier Lyon Sud, Hematology. Lyon
Giovanni Martinelli, MD
Role: STUDY_CHAIR
Hemato-oncology. European Oncology Institute. Milan
Peter Johnson, MD
Role: STUDY_CHAIR
Oncology Unit. Southampton General Hospital. Southampton
Maurizio Martelli, MD
Role: STUDY_CHAIR
Hematology. Università La Sapienza. Roma
Locations
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ACZA Campus Stuivenberg
Antwerp, , Belgium
AZ StJan
Bruges, , Belgium
St Luc
Brussels, , Belgium
ULB Hopital Erasme
Brussels, , Belgium
CHNDRF
Charleroi, , Belgium
Hospital St Joseph
Gilly, , Belgium
UCL de Mont Godinne
Yvoir, , Belgium
Centre Hospitalier de Blois
Blois, , France
Hopital Avicenne
Bobigny, , France
CHU
Dijon, , France
Centre Hospitalier
Lens, , France
CHRU Lille
Lille, , France
Centre Hospitalier Lyon Sud
Lyon, , France
Centre Leon Berard
Lyon, , France
Institut Paoli Calmettes
Marseille, , France
Hopital Arnold Villeneuve
Monpellier, , France
CHU
Nancy, , France
CHU Hotel Dieu
Nantes, , France
Centre R. Gauducheau
Nantes-St. Herblain, , France
Hopital Henri-Mondor
Paris, , France
Hopital St Louis
Paris, , France
Necker
Paris, , France
Centre Henri Becquerel
Rouen, , France
Spedali Civili
Brescia, , Italy
Azienda ULSS 15 Alta Padovana
Cittadella, , Italy
IST
Genova, , Italy
Humanitas
Milan, , Italy
San Raffaele Hospital
Milan, , Italy
IEO
Milan, , Italy
INT
Milan, , Italy
Policlinico
Modena, , Italy
Ospedale Civile
Piacenza, , Italy
A.O. Bianchi-Melacrino-Morelli, Divisione di Ematologia
Reggio Calabria, , Italy
Arcispedale S. Maria Nuova
Reggio Emilia, , Italy
S. Eugenio
Rome, , Italy
Università Cattolica Sacro Cuore
Rome, , Italy
Università La Sapienza
Rome, , Italy
Sassuolo GISL
Sassuolo, , Italy
AOU Senese
Siena, , Italy
A.O.U. San Giovanni Battista-Molinette, S.C. Ematologia 2
Torino, , Italy
Trani GISL
Trani, , Italy
Ospedale di Circolo Fondazione Macchi
Varese, , Italy
Policlinico GB Rossi
Verona, , Italy
Clinic Hospital Universitari
Barcelona, , Spain
Hopital Mataro'
Barcelona, , Spain
Hopital Santa Creu i Sant Pau
Barcelona, , Spain
University Hospital
Salamanca, , Spain
Joan XXIII
Tarragona, , Spain
IOSI
Bellinzona, , Switzerland
Aberdeen Royal Infirmary
Aberdeen, , United Kingdom
Heartlands
Birmingham, , United Kingdom
Victoria Hospital
Blackpool, , United Kingdom
Royal Cornwall Hospital
Cornwall, , United Kingdom
Darent Valley Hospital
Dartford, , United Kingdom
Royal Devon &Exeter Healtcare NHS Trust
Devon, , United Kingdom
Russels Hall Hospital
Dudley, , United Kingdom
Western General Hospital
Edinburgh, , United Kingdom
Medway Hospital
Gillingham, , United Kingdom
Raigmore Hospital
Inverness, , United Kingdom
Liverpool Royal Hospital
Liverpool, , United Kingdom
University Hospital Aintree
Liverpool, , United Kingdom
Barts & the London NHS Trust
London, , United Kingdom
Royal Marsden NHS Foundation Trust
London, , United Kingdom
St Georges
London, , United Kingdom
Christie Hospital
Manchester, , United Kingdom
Mount Vernon Hospital
Middlesex, , United Kingdom
James Paget Hospital
Norfolk, , United Kingdom
Queen Elisabeth
Norfolk, , United Kingdom
Nottingham City Hospital
Nottingham, , United Kingdom
John Radcliffe
Oxford, , United Kingdom
Conquest Hospital
Saint Leonard on Sea, , United Kingdom
Weston Park
Sheffield, , United Kingdom
Southampton General Hospital
Southampton, , United Kingdom
Sandwell General Hospital
West Bromwich, , United Kingdom
Worchestershire Acute Hospital NHS Trust
Worcester, , United Kingdom
Countries
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References
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Bommier C, Zucca E, Chevret S, Conconi A, Nowakowski G, Maurer MJ, Cerhan JR, Thieblemont C, Lambert J. Early complete response as a validated surrogate marker in extranodal marginal zone lymphoma systemic therapy. Blood. 2024 Feb 1;143(5):422-428. doi: 10.1182/blood.2023020984.
Zucca E, Conconi A, Laszlo D, Lopez-Guillermo A, Bouabdallah R, Coiffier B, Sebban C, Jardin F, Vitolo U, Morschhauser F, Pileri SA, Copie-Bergman C, Campo E, Jack A, Floriani I, Johnson P, Martelli M, Cavalli F, Martinelli G, Thieblemont C. Addition of rituximab to chlorambucil produces superior event-free survival in the treatment of patients with extranodal marginal-zone B-cell lymphoma: 5-year analysis of the IELSG-19 Randomized Study. J Clin Oncol. 2013 Feb 10;31(5):565-72. doi: 10.1200/JCO.2011.40.6272. Epub 2013 Jan 7.
Related Links
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Click here for more information about this study
Other Identifiers
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IELSG19
Identifier Type: -
Identifier Source: org_study_id
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