Randomized, Open-label, Two-arms, Phase III Comparative Study Assessing the Role of Involved Mediastinal Radiotherapy After Rituximab Containing Chemotherapy Regimens to Patients With Newly Diagnosed Primary Mediastinal Large B-Cell Lymphoma
NCT ID: NCT01599559
Last Updated: 2026-01-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ACTIVE_NOT_RECRUITING
NA
540 participants
INTERVENTIONAL
2012-10-31
2029-12-17
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Following chemoimmunotherapy patients receive radiation therapy if they have residues which may be active tumour. However at the end of chemoimmunotherapy the majority of patients show tissue scarring that is not necessarily active tumor. In recent years, PET/CT has proved to be a good tool to accurately identify active tumor from scar tissue in patients treated for mediastinal lymphoma.The purpose of this trial is to test whether radiation therapy is really necessary in patients where PET/CT has shown that the tumor is no longer active. Therefore we will compare radiation treatment with careful observation.
Patients that at the end of conventional treatment of chemoimmunotherapy have a negative PET/CT (i.e., without residues suspected to contain active tumor), will randomly assigned to two different treatment groups: one treatment group will receive the radiation treatment, and the other treatment group will receive careful observation.
The trial is planned according to a non-inferiority design aimed at demonstrating that progression free survival after the experimental treatment (observation) is not worse than after the standard comparator (mediastinal irradiation.Participation in this study could spare patients with complete remission at the end of chemo immunotherapy (PET/CT negative) radiation therapy that may be unnecessary.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
131I-rituximab for Relapsed or Refractory Marginal Zone B-cell Lymphoma
NCT01678404
Relmacabtagene Autoleucel as First-Line Therapy for High-Risk Large B-Cell Lymphoma
NCT05590221
Radioimmunotherapy in Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma
NCT00005592
Large Fraction Radiation Therapy Combined With Lenalidomide, and Glofitamab in Refractory Relapsed DLBCL
NCT06651853
An Open-Label, Single Center Phase 2 Study of Magrolimab, Rituximab and Radiation as Bridging Strategy Before CAR T-Cell Therapy in Patients With Relapsed or Refractory Large B-cell Lymphoma
NCT05929716
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
observation
Follow up visits are scheduled from randomization. Patients will be seen at 3-months intervals for 24 months, then every 6 months until 5 years from randomization.
observation
observation
mediastinal irradiation
Radiotherapy will be delivered in this phase III protocol, as alternative to observation, as consolidation treatment in patients achieving a CR status (PET/CT scan negative) at the end of R-chemotherapy, with a total dose of 30 Gy.
3D-Conformal Radiotherapy (3D-CRT)
Radiation treatment should start within 6-8 weeks after the end of chemotherapy.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
observation
observation
3D-Conformal Radiotherapy (3D-CRT)
Radiation treatment should start within 6-8 weeks after the end of chemotherapy.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Patients must have histological confirmation of the diagnosis (it is recommended that the immunohistochemical panel includes: CD45, CD20, CD30, CD15, CD10, BCL6, BCL2, MUM-1), and in addition have a dominant mass within the anterior mediastinum.
* No evidence of extranodal disease outside the chest including spleen and bone marrow.
* Age at least 18 years.
* Fit to receive chemotherapy and radiotherapy with curative intent.
* Patients will be eligible if the treatment phase consisting in a Rituximab combined with any anthracycline-containing chemotherapy regimen without consolidation with autologous stem cell support (e.g., 6 cycles of CHOP14-21, DA-EPOCH, Mega-CHOP or 12 weeks of VACOP-B or MACOP-B).
* At least 6 courses of Rituximab should be administered
* Able and willing to give informed consent, and to undergo staging including PET scanning
* Willingness to comply with an appropriate contraceptive method in women of childbearing potential or men.
* Histological diagnostic material available for review.
Exclusion Criteria
* Evidence of clinically significant cardiac disease at diagnosis, as defined by history of symptomatic ventricular arrhythmias, congestive heart failure or myocardial infarction within 12 months before study entry. Cardiac impairment due to local extension of lymphoma will not be an exclusion criterion in the absence of other cardiac disease.
* Known HIV-positive serology.
* Pregnant or lactating women.
* Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
International Extranodal Lymphoma Study Group (IELSG)
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Maurizio Martelli, MD
Role: STUDY_CHAIR
Università La Sapienza (Rome - Italy)
Andrew J Davies, MD
Role: STUDY_CHAIR
University of Southampton (UK)
Mary Gospodarowicz, MD
Role: STUDY_CHAIR
Princess Margaret Hospital Toronto (Canada)
Sally F Barrington, MD
Role: STUDY_CHAIR
St. Thomas' - London (UK)
Alberto Biggi, MD
Role: STUDY_CHAIR
AO S. Croce e Carle, Cuneo (Italia)
Annibale Versari, MD
Role: STUDY_CHAIR
S.Maria Nuova Hospital, Reggio Emilia (Italia)
Gianni Ciccone, MD
Role: STUDY_CHAIR
CPO Torino (Italy)
Stèphane Chauvie, MD
Role: STUDY_CHAIR
AO S. Crtoce e Carle - Cuneo (Italy)
Luca Ceriani, MD
Role: STUDY_CHAIR
IOSI - Bellinzona (Switzerland)
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Norton Cancer Institute
Louisville, Kentucky, United States
Mayo Clinil Rocheser
Rochester, Minnesota, United States
MD Anderson Cancer Center
Houston, Texas, United States
Centro de Hematologia y Oncologia Pavlovsky
Buenos Aires, , Argentina
Princess Margaret Hospital
Toronto, , Canada
Ruijin Hospital
Shanghai, , China
Faculty Hospital Brno
Brno, , Czechia
University Hospital
Hradec Králové, , Czechia
Faculty Hospital Kralovske Vinohrady
Prague, , Czechia
General University Hospital
Prague, , Czechia
University of Duisburg-Essen, Campus Essen
Essen, , Germany
A.O. SS. Antonio e Biagio e Cesare Arrigo
Alessandria, , Italy
Clinica di Ematologia Ospedali Riuniti "Umberto I"
Ancona, , Italy
Centro di Riferimento Oncologico - Aviano
Aviano, , Italy
A.O.U Policlinico Consorziale di Bari
Bari, , Italy
Bari IRCCS Istituto Tumori
Bari, , Italy
Ospedale Mons. Dimiccoli
Barletta, , Italy
Ospedale Papa Giovanni Xxiii
Bergamo, , Italy
Sant'Orsola Malpighi
Bologna, , Italy
Comprensorio Sanitario di Bolzano
Bolzano, , Italy
Spedali Civili
Brescia, , Italy
Asl Uoc Ematologia A Perrino
Brindisi, , Italy
Ospedale Businco
Cagliari, , Italy
AO Garibaldi Nesima Catalia
Catania, , Italy
Ospedale S. Croce e Carle
Cuneo, , Italy
Unità Funzionale di Ematologia AOU Careggi
Florence, , Italy
U.O. Ematologia Vito Fazzi
Lecce, , Italy
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
Meldola, , Italy
SC Ematologia Azienda Ospedali Riuniti Papardo Piemonte
Messina, , Italy
Istituto Scientifico San Raffaele
Milan, , Italy
Milano Ieo
Milan, , Italy
SC Ematologia AO Niguarda
Milan, , Italy
AOU Policlinico di Modena
Modena, , Italy
Ematologia Università degli Studi di Federico II
Napoli, , Italy
Ospedale Umberto I
Nocera Inferiore, , Italy
Azienda Ospedaliera Universitaria
Padua, , Italy
Ospedali Riuniti Villa Sofia
Palermo, , Italy
AOU di Parma
Parma, , Italy
Fondazione IRCCS S. Matteo
Pavia, , Italy
S.C. Ematologia Ospedale S. Marid Della Misericordia
Perugia, , Italy
Ospedale Civile di Pescara
Pescara, , Italy
Ospedale Civico Guglielmo di Saliceto
Piacenza, , Italy
Ospedale San Carlo di Potenza
Potenza, , Italy
U.O. Oncologia Ematologia Ospedale S. Maria Delle Croci
Ravenna, , Italy
A.O. Bianchi-Melacrino-Morelli, Divisione di Ematologia
Reggio Calabria, , Italy
ICCRS Azienda Ospedaliera Arcipedale "Santa Maria Nuova"
Reggio Emilia, , Italy
Ospedale Degli Infermi
Rimini, , Italy
Fondazione PTV Policlinico Tor Vergata
Roma, , Italy
AO San Camillo Forlanini
Roma, , Italy
AOU S. Andrea Roma
Roma, , Italy
Ospedale S. Eugenio
Roma, , Italy
Policlinico Universitario Campus Bio-Medico
Roma, , Italy
Roma Regina Elena IFO
Roma, , Italy
Roma San Giovanni
Roma, , Italy
Università degli Studi La Sapienza
Roma, , Italy
Rozzano Humanitas
Rozzano, , Italy
Siena
Siena, , Italy
AOS Maria di Terni
Terni, , Italy
AOS S. Giovanni Battista "Molinette"
Torino, , Italy
Azienda Ospedaliera Citta Della Salute E Della Scienza Di Torino
Torino, , Italy
Ospedale Cardinale Panico
Tricase, , Italy
Azienda Ospedaliera Univesritaria
Udine, , Italy
Asst Settelaghi Ospedale Macchi
Varese, , Italy
Oslo University Hospital
Oslo, , Norway
St Olavs Hospital
Trondheim, , Norway
Warsaw Centrum Onkologi Instytucie
Warsaw, , Poland
Istituto Portugues de Oncologia de Lisboa
Lisbon, , Portugal
Lund Universitet
Lund, , Sweden
IOSI
Bellinzona, , Switzerland
Inselspital Bern
Bern, , Switzerland
Kantonsspital Olten
Olten, , Switzerland
Kantonsspital
Sankt Gallen, , Switzerland
Kyiv National Cancer Institute
Kiev, , Ukraine
Basingstoke & North Hamptshire Hospital
Basingstoke, , United Kingdom
Birmingham Heartlands Hospital
Birmingham, , United Kingdom
Glasgow Beatson Cancer Center
Glasgow, , United Kingdom
Leeds St. James's Hospital
Leeds, , United Kingdom
Royal Liverpool University Hospital
Liverpool, , United Kingdom
Guy's & St. Thomas London
London, , United Kingdom
UCLH St. Thomas
London, , United Kingdom
Manchester The Christie NHS Foundation Trust
Manchester, , United Kingdom
Newcastle Freeman Hospital
Newcastle, , United Kingdom
Norfolk & Norwich University Hospital
Norfolk, , United Kingdom
Nottingham University Hospital
Nottingham, , United Kingdom
General Hospital
Southampton, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Zucca E, Ceriani L, Ciccone G, Di Rocco A, Pirosa MC, Kriachok I, Botto B, Balzarotti M, Tucci A, Usai SV, Zilioli VR, Pennese E, Arcaini L, Dabrowska-Iwanicka A, Ferreri AJM, Merli F, Zhao W, Rigacci L, Cellini C, Hodgson D, Ionescu C, Minoia C, Lucchini E, Spina M, Fossa A, Janikova A, Cwynarski K, Mikhaeel NG, Jerkeman M, Stathis A, Cozens K, Ielmini N, De Martino I, Walewski J, Trneny M, Cavalli F, Ricardi U, Johnson PWM, Davies A, Martelli M. Impact of immunochemotherapy regimens on outcomes of patients with primary mediastinal B-cell lymphoma in the IELSG37 trial. Blood. 2025 Dec 4;146(23):2758-2764. doi: 10.1182/blood.2025028823.
Martelli M, Ceriani L, Ciccone G, Ricardi U, Kriachok I, Botto B, Balzarotti M, Tucci A, Usai SV, Zilioli VR, Pennese E, Arcaini L, Dabrowska-Iwanicka A, Ferreri AJM, Merli F, Zhao W, Rigacci L, Cellini C, Hodgson D, Ionescu C, Minoia C, Lucchini E, Spina M, Fossa A, Janikova A, Cwynarski K, Mikhaeel G, Jerkeman M, Di Rocco A, Stepanishyna Y, Vitolo U, Santoro A, Re A, Puccini B, Olivieri J, Petrucci L, Barrington SF, Malkowski B, Metser U, Versari A, Chauvie S, Walewski J, Trneny M, Cavalli F, Gospodarowicz M, Johnson PWM, Davies A, Zucca E; International Extranodal Lymphoma Study Group (IELSG). Omission of Radiotherapy in Primary Mediastinal B-Cell Lymphoma: IELSG37 Trial Results. J Clin Oncol. 2024 Dec;42(34):4071-4083. doi: 10.1200/JCO-24-01373. Epub 2024 Aug 19.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
IELSG37
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.