Randomized Trial of Chlorambucil Versus Chlorambucil Plus Rituximab Versus Rituximab in MALT Lymphoma

PHASE3CompletedINTERVENTIONAL
Enrollment

454

Participants

Timeline

Start Date

January 31, 2003

Primary Completion Date

April 30, 2015

Study Completion Date

February 17, 2016

Conditions
Lymphoma, Mucosa-Associated Lymphoid Tissue
Interventions
DRUG

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)

DRUG

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

DRUG

rituximab

rituximab 375 mg/m2 iv on days 1, 8, 15, 22, 56, 84, 112, 140

Trial Locations (75)

6500

IOSI, Bellinzona

10134

A.O.U. San Giovanni Battista-Molinette, S.C. Ematologia 2, Torino

Unknown

ACZA Campus Stuivenberg, Antwerp

AZ StJan, Bruges

St Luc, Brussels

ULB Hopital Erasme, Brussels

CHNDRF, Charleroi

Hospital St Joseph, Gilly

UCL de Mont Godinne, Yvoir

Centre Hospitalier de Blois, Blois

Hopital Avicenne, Bobigny

CHU, Dijon

Centre Hospitalier, Lens

CHRU Lille, Lille

Centre Hospitalier Lyon Sud, Lyon

Centre Leon Berard, Lyon

Institut Paoli Calmettes, Marseille

Hopital Arnold Villeneuve, Monpellier

CHU, Nancy

CHU Hotel Dieu, Nantes

Centre R. Gauducheau, Nantes-St. Herblain

Hopital Henri-Mondor, Paris

Hopital St Louis, Paris

Necker, Paris

Centre Henri Becquerel, Rouen

Spedali Civili, Brescia

Azienda ULSS 15 Alta Padovana, Cittadella

IST, Genova

Humanitas, Milan

San Raffaele Hospital, Milan

IEO, Milan

INT, Milan

Policlinico, Modena

Ospedale Civile, Piacenza

A.O. Bianchi-Melacrino-Morelli, Divisione di Ematologia, Reggio Calabria

Arcispedale S. Maria Nuova, Reggio Emilia

S. Eugenio, Rome

Università Cattolica Sacro Cuore, Rome

Università La Sapienza, Rome

Sassuolo GISL, Sassuolo

AOU Senese, Siena

Trani GISL, Trani

Ospedale di Circolo Fondazione Macchi, Varese

Policlinico GB Rossi, Verona

Clinic Hospital Universitari, Barcelona

Hopital Mataro', Barcelona

Hopital Santa Creu i Sant Pau, Barcelona

University Hospital, Salamanca

Joan XXIII, Tarragona

Aberdeen Royal Infirmary, Aberdeen

Heartlands, Birmingham

Victoria Hospital, Blackpool

Royal Cornwall Hospital, Cornwall

Darent Valley Hospital, Dartford

Royal Devon &Exeter Healtcare NHS Trust, Devon

Russels Hall Hospital, Dudley

Western General Hospital, Edinburgh

Medway Hospital, Gillingham

Raigmore Hospital, Inverness

Liverpool Royal Hospital, Liverpool

University Hospital Aintree, Liverpool

Barts & the London NHS Trust, London

Royal Marsden NHS Foundation Trust, London

St Georges, London

Christie Hospital, Manchester

Mount Vernon Hospital, Middlesex

James Paget Hospital, Norfolk

Queen Elisabeth, Norfolk

Nottingham City Hospital, Nottingham

John Radcliffe, Oxford

Conquest Hospital, Saint Leonard on Sea

Weston Park, Sheffield

Southampton General Hospital, Southampton

Sandwell General Hospital, West Bromwich

Worchestershire Acute Hospital NHS Trust, Worcester

All Listed Sponsors
lead

International Extranodal Lymphoma Study Group (IELSG)

OTHER

NCT00210353 - Randomized Trial of Chlorambucil Versus Chlorambucil Plus Rituximab Versus Rituximab in MALT Lymphoma | Biotech Hunter | Biotech Hunter