Clinical trial • Phase II • Oncology

Rituximab for Extranodal marginal zone B-cell lymphoma (MALT lymphoma)

Phase II trial of Rituximab for Extranodal marginal zone B-cell lymphoma (MALT lymphoma). 106 participants.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Extranodal marginal zone B-cell lymphoma (MALT lymphoma)
Trial Stage
Phase II
Drug Modality
Monoclonal antibody|Small molecule

Key dates

Initial CTIS Submission Date
09-08-2024
First CTIS Authorization Date
01-10-2024

Trial design

Phase II trial across 38 sites in France, Italy.

Target Sample Size
106
Trial Duration For Participant
912

Eligibility

Recruits 106 adults.

Inclusion criteria

  • {"criterion_text":"- Histologically proven diagnosis of CD20-positive marginal zone B-cell lymphoma of MALT type either de novo, or relapsed following local therapy (including surgery, radiotherapy and antibiotics for H. pylori-positive gastric lymphoma) arisen at any extranodal site"}
  • {"criterion_text":"- Measurable or evaluable disease"}
  • {"criterion_text":"- Any stage (Ann Arbor I-IV)"}
  • {"criterion_text":"- Age >= 18"}

Exclusion criteria

  • {"criterion_text":"- Evidence of histologic transformation to a high grade lymphoma"}
  • {"criterion_text":"- Prior chemotherapy"}
  • {"criterion_text":"- Prior radiotherapy in the last 6 weeks"}
  • {"criterion_text":"- Prior immunotherapy with any anti-CD20 monoclonal antibody"}
  • {"criterion_text":"- Known HIV, active Hepatitis B (HB) and Hepatitis C (HC) infections"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Complete Remission rate at the end of induction phase (6 months)","definition_or_measurement_approach":""}

Secondary endpoints

  • {"endpoint_text":"- Response Rate (Complete and partial remission rates) at the end of induction phase ( 6 months from study entry)","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Progression Free Survival","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Event-free-survival (EFS) at 5 years","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Overall survival","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Response duration","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Acute and long-term toxicity","definition_or_measurement_approach":""}

Recruitment

Planned Sample Size
106
Recruitment Window Months
144

Geography

Total Number Of Sites
38
Total Number Of Participants
106

France

Earliest CTIS Part Ii Submission Date
26-08-2024
Latest Decision Or Authorization Date
02-12-2024
Processing Time Days
98
Number Of Sites
14
Number Of Participants
40

Sites

Site Name
Institut Paoli-Calmettes
Department Name
Hematology
Contact Person Name
Jean-Marc Schiano De Colella
Contact Person Email
schianojm@ipc.unicancer.fr
Site Name
Assistance Publique Hopitaux De Paris
Department Name
Hematology
Contact Person Name
Catherine THIEBLEMONT
Contact Person Email
catherine.thieblemont@aphp.fr
Site Name
Centre Hospitalier Universitaire De Montpellier
Department Name
Hematology
Contact Person Name
Guillaume CARTRON
Contact Person Email
g-cartron@chu-montpellier.fr
Site Name
Centre Hospitalier Lyon Sud
Department Name
Hematology
Contact Person Name
Hervé Ghesquieres
Contact Person Email
herve.ghesquieres@chu-lyon.fr
Site Name
Centre Hospitalier Regional Universitaire De Tours
Department Name
Hematology
Contact Person Name
Emmanuel GYAN
Contact Person Email
e.gyan@chu-tours.fr
Site Name
Centre Hospitalier Universitaire De Rennes
Department Name
Hematology
Contact Person Name
Thierry Lamy de la Chapelle
Site Name
Centre Henri Becquerel
Department Name
Hematology
Contact Person Name
Hervé Tilly
Contact Person Email
herve.tilly@chb.unicancer.fr
Site Name
CHRU De Nancy
Department Name
Hematology
Contact Person Name
Pierre FEUGIER
Contact Person Email
p.feugier@chru-nancy.fr
Site Name
University Hospital Of Clermont-Ferrand
Department Name
Hematology
Contact Person Name
Benoit DE RENZIS
Site Name
Assistance Publique Hopitaux De Paris
Department Name
Hematology
Contact Person Name
Corinne Haioun
Contact Person Email
corinne.haioun@hmn.aphp.fr
Site Name
Centre Hospitalier Universitaire Grenoble Alpes
Department Name
Hematology
Contact Person Name
Rémy Gressin
Contact Person Email
rgressin@chu-grenoble.fr
Site Name
Centre Hospitalier Universitaire De Nantes
Department Name
Hematology
Contact Person Name
Thomas GASTINNE
Contact Person Email
thomas.gastinne@chu-nantes.fr
Site Name
Centre Hospitalier Universitaire De Dijon
Department Name
Hematology
Contact Person Name
Cédric ROSSI
Contact Person Email
cedric.rossi@chu-dijon.fr
Site Name
Centre Hospitalier Universitaire De Lille
Department Name
Hematology
Contact Person Name
Franck MORSCHHAUSER

Italy

Earliest CTIS Part Ii Submission Date
26-08-2024
Latest Decision Or Authorization Date
25-11-2025
Processing Time Days
456
Number Of Sites
24
Number Of Participants
66

Sites

Site Name
Azienda Sanitaria Locale Di Pescara
Department Name
UOC Ematologia Dipartimento Oncologico Ematologico - ASL Pescara - P.O. Spirito Santo di Pescara
Contact Person Name
Elsa Pennese
Contact Person Email
elsa.pennese@asl.pe.it
Site Name
Centro Di Riferimento Oncologico Di Aviano
Department Name
Divisione di Oncologia e dei Tumori immuno-correlati
Contact Person Name
Michele Spina
Contact Person Email
mspina@cro.it
Site Name
Azienda Unita Sanitaria Locale Della Romagna
Department Name
Ematologia - Ospedale delle Croci
Contact Person Name
Monica Tani
Contact Person Email
monica.tani@auslromagna.it
Site Name
Azienda USL IRCCS Di Reggio Emilia
Department Name
Ematologia
Contact Person Name
Francesco Merli
Contact Person Email
merli.francesco@ausl.re.it
Site Name
Azienda Unita' Sanitaria Locale Toscana Nord Ovest
Department Name
Ematologia - Ospedale di Livorno
Contact Person Name
Enrico Capochiani
Contact Person Email
e.capochiani@usl6.toscana.it
Site Name
Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
Department Name
Ematologia Universitaria
Contact Person Name
Federica Cavallo
Contact Person Email
f.cavallo@unito.it
Site Name
Azienda Socio Sanitaria Territoriale Dei Sette Laghi
Department Name
U.O.C Ematologia
Contact Person Name
Marco Brociner
Site Name
Azienda Sanitaria Locale Di Salerno
Department Name
U.O. Onco-ematologia - Presidio ospedaliero "A. TORTORA"
Contact Person Name
Catello Califano
Contact Person Email
c.califano@aslsalerno.it
Site Name
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
Department Name
Ematologia
Contact Person Name
Gerardo Musuraca
Contact Person Email
gerardo.musuraca@irst.emr.it
Site Name
Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
Department Name
S.C.Ematologia
Contact Person Name
Carola Boccomini
Site Name
Azienda Ospedaliera S Maria Di Terni
Department Name
S.C. Oncoematologia
Contact Person Name
Arcangelo Liso
Contact Person Email
arcangelo.liso@aospterni.it
Site Name
Istituto Di Ricovero E Cura A Carattere Scientifico Centro Di Riferimento Oncologico Della Basilicata
Department Name
UO di ematologia e Trapianto Cellule Staminali
Contact Person Name
Giuseppe Pietrantuono
Contact Person Email
ematologia45@alice.it
Site Name
Fondazione IRCCS Istituto Nazionale Dei Tumori
Department Name
Ematologia
Contact Person Name
Liliana Franca Devizzi
Site Name
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Department Name
Ematologia
Contact Person Name
Francesca Gaia Rossi
Site Name
Azienda Sanitaria Locale Della Provincia Di Biella
Department Name
SSD Ematologia
Contact Person Name
Annarita Conconi
Site Name
Azienda Unita' Sanitaria Locale Toscana Sud Est
Department Name
U.O. Ematologia - Ospedale San Donato - USL8 - Arezzo
Contact Person Name
Alessandra Caremani
Site Name
Istituto Oncologico Veneto
Department Name
Oncologia 1
Contact Person Name
Dario Marino
Contact Person Email
dario.marino@iov.veneto.it
Site Name
Azienda Ospedaliero-Universitaria Ss.Antonio E Biagio E C.Arrigo Alessandria
Department Name
SCDU Ematologia
Contact Person Name
Manuela Zanni
Contact Person Email
manuela.zanni@ospedale.al.it
Site Name
ARNAS G. Brotzu
Department Name
SC Ematologia e CTMO - Ospedale Businco
Contact Person Name
Sara Veronica Usai
Contact Person Email
sara.v.usai@aob.it
Site Name
I.F.O. Istituti Fisioterapici Ospitalieri
Department Name
Ematologia e Trapianto
Contact Person Name
Francesca Palombi
Contact Person Email
francesca.palombi@ifo.it
Site Name
Azienda Unita Sanitaria Locale Della Romagna
Department Name
U.O. di Ematologia -Ospedale degli Infermi di Rimini
Contact Person Name
Melania Celli
Contact Person Email
melania.celli@auslromagna.it
Site Name
Azienda Ospedaliero Universitaria Parma
Department Name
UOC Ematologia e CTMO
Contact Person Name
Filomena Russo
Contact Person Email
milenarusso4@gmail.com
Site Name
Azienda Ospedaliero-Universitaria Policlinico Umberto I
Department Name
Istituto Ematologia -Dipartimento di Medicina Traslazionale e di Precisione
Contact Person Name
Ilaria Del Giudice
Contact Person Email
ilaria.delgiudice@uniroma1.it
Site Name
Azienda Ospedaliero Universitaria Delle Marche
Department Name
Clinica di Ematologia - AOU Ospedali Riuniti
Contact Person Name
Guido Gini

Sponsor

Primary sponsor

Full Name
Association International Extranodal Lymphoma Study Group (IELSG)
Organisation Type
Laboratory/Research/Testing facility
Country Of Registered Address
Switzerland

Third parties

  • {"country":"France","full_name":"LYSARC","duties_or_roles":"codes: 1,12,2","organisation_type":"Laboratory/Research/Testing facility"}

Investigational products

Investigational Product Name
MabThera 500 mg concentrate for solution for infusion
Active Substance
Rituximab
Modality
Monoclonal antibody
Routes Of Administration
INTRAVENOUS USE
Route
Intravenous
Authorisation Status
Marketing authorisation: EU/1/98/067/002
Maximum Dose
375 mg/m2
Investigational Product Name
MabThera 1400 mg solution for subcutaneous injection
Active Substance
Rituximab
Modality
Monoclonal antibody
Routes Of Administration
SUBCUTANEOUS
Route
Subcutaneous
Authorisation Status
Marketing authorisation: EU/1/98/067/003
Maximum Dose
1400 mg
Investigational Product Name
CHLORAMBUCIL
Active Substance
Chlorambucil
Modality
Small molecule
Routes Of Administration
ORAL USE
Route
Oral
Authorisation Status
Marketing authorisation: -
Maximum Dose
6 mg/m2
Combination Treatment
Yes

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