Randomized Trial of Chlorambucil Versus Chlorambucil Plus Rituximab Versus Rituximab in MALT Lymphoma
Multicenter Randomized Trial of Chlorambucil Versus Chlorambucil Plus Rituximab Versus Rituximab in Extranodal Marginal Zone B-cell Lymphoma of Mucosa Associated Lymphoid Tissue (MALT Lymphoma)
1 other identifier
interventional
454
6 countries
75
Brief Summary
Assess the therapeutic activity and safety of the combination of Chlorambucil and Rituximab in MALT lymphomas and determine whether the addition of Rituximab to Chlorambucil will improve the outcome of MALT lymphoma in comparison to treatment with Chlorambucil alone. In April 2006, a third arm of treatment was added to compare the antitumor activity and safety of rituximab alone vs chlorambucil alone
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jan 2003
Longer than P75 for phase_3
75 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2003
CompletedFirst Submitted
Initial submission to the registry
September 13, 2005
CompletedFirst Posted
Study publicly available on registry
September 21, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
February 17, 2016
CompletedResults Posted
Study results publicly available
June 6, 2019
CompletedJune 6, 2019
October 1, 2018
12.3 years
September 13, 2005
October 17, 2018
March 1, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Event-free-survival (EFS)
Percentage of patients without events (failure of treatment or Death from any cause) after 5 years from trial registration
5 years
Secondary Outcomes (4)
Complete and Partial Remission Rate - Percentage of Patients With Complete and Partial Response at the End of Treatment
End of treatment (after 24 weeks of therapy)
Response Duration (Time to Relapse or Progression) - Percentage of Patients in Continuous Remission at Five Years From Trial Registration
5 years
Progression-free-survival (PFS)
5 years
Overall Survival
5 years
Study Arms (3)
ARM A
ACTIVE COMPARATORchlorambucil 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
EXPERIMENTALrituximab 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
ARM C (Since April 2006)
EXPERIMENTALrituximab 375 mg/m2 iv on days 1, 8, 15, 22, 56, 84, 112, 140
Interventions
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 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
Eligibility Criteria
You may qualify if:
- histologically proven diagnosis of CD20-positive marginal zone B-cell lymphoma of MALT type arisen at any extranodal site
- any stage (Ann Arbor I-IV)
- either de novo, or relapsed disease following local therapy (including surgery, radiotherapy and antibiotics for H. pylori-positive gastric lymphoma)
- no evidence of histologic transformation to a high grade lymphoma
- measurable or evaluable disease
- age \> 18
- life expectancy of at least 1 year
- ECOG performance status 0-2
- no prior diagnosis of neoplasm within 5 years, except cervical intraepithelial neoplasia type 1 (CIN1) or localized non-melanomatous skin cancer
- no prior chemotherapy
- no prior immunotherapy with any anti-CD20 monoclonal antibody
- no prior radiotherapy in the last 6 weeks
- 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
- 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
- no evidence of symptomatic central nervous system (CNS) disease
- +9 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (75)
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, 10134, 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, 6500, 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
Related Publications (2)
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.
PMID: 37801707DERIVEDZucca 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.
PMID: 23295789DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Prof. Emanuele Zucca MD, Scientific and Medical Director
- Organization
- International Extranodal Lymphoma Study Group (IELSG)
Study Officials
- STUDY CHAIR
Emanuele Zucca, MD
International Extranodal Lymphoma Study Group/Oncology Institute of Southern Switzerland. Bellinzona
- STUDY CHAIR
Emilio Montserrat, MD
Clinic Hospital Universitari, Hematology. Barcelona
- STUDY CHAIR
Catherine Thieblemont, MD
Centre Hospitalier Lyon Sud, Hematology. Lyon
- STUDY CHAIR
Giovanni Martinelli, MD
Hemato-oncology. European Oncology Institute. Milan
- STUDY CHAIR
Peter Johnson, MD
Oncology Unit. Southampton General Hospital. Southampton
- STUDY CHAIR
Maurizio Martelli, MD
Hematology. Università La Sapienza. Roma
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 13, 2005
First Posted
September 21, 2005
Study Start
January 1, 2003
Primary Completion
April 1, 2015
Study Completion
February 17, 2016
Last Updated
June 6, 2019
Results First Posted
June 6, 2019
Record last verified: 2018-10