Primary Mediastinal B-cell LymphomaNCT01599559
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
A study testing observation and 3D-Conformal Radiotherapy (3D-CRT) in people with Primary Mediastinal B-cell Lymphoma, run by International Extranodal Lymphoma Study Group (IELSG) at 85 sites in 14 countries.
Trial summary
Primary mediastinal large B cell lymphoma is treated with a combination of chemotherapy and the monoclonal antibody rituximab (chemoimmunotherapy). Following chemoimmunotherapy patients receive radiation therapy if they have residues which may be active tumour. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Mediastinal B-cell Lymphoma
- What is being tested?
- observation and 3D-Conformal Radiotherapy (3D-CRT)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 540 participants
- Where
- 85 sitesin 14 countries
- Study dates
- Oct 2012to 17 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Previously untreated primary mediastinal diffuse large B-cell lymphoma, CD20 positive.
- 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).
Show all 10Show fewer
- 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.
Who cannot join
- History of malignancy other than squamous cell carcinoma, basal cell carcinoma of the skin or carcinoma in situ of the cervix within the last 5 years.
- 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.
Trial locations and contacts
85 sites in 14 countries.
85 sites in 14 countries
Italy52 sites
A.O. SS. Antonio e Biagio e Cesare Arrigo
Alessandria
Clinica di Ematologia Ospedali Riuniti "Umberto I"
Ancona
Centro di Riferimento Oncologico - Aviano
Aviano
A.O.U Policlinico Consorziale di Bari
Bari
Bari IRCCS Istituto Tumori
Bari
Ospedale Mons. Dimiccoli
Barletta
Ospedale Papa Giovanni Xxiii
Bergamo
Sant'Orsola Malpighi
Bologna
Comprensorio Sanitario di Bolzano
Bolzano
Spedali Civili
Brescia
Asl Uoc Ematologia A Perrino
Brindisi
Ospedale Businco
Cagliari
AO Garibaldi Nesima Catalia
Catania
Ospedale S. Croce e Carle
Cuneo
Unità Funzionale di Ematologia AOU Careggi
Florence
U.O. Ematologia Vito Fazzi
Lecce
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
Meldola
SC Ematologia Azienda Ospedali Riuniti Papardo Piemonte
Messina
Istituto Scientifico San Raffaele
Milan
Milano Ieo
Milan
SC Ematologia AO Niguarda
Milan
AOU Policlinico di Modena
Modena
Ematologia Università degli Studi di Federico II
Naples
Ospedale Umberto I
Nocera Inferiore
Azienda Ospedaliera Universitaria
Padova
Ospedali Riuniti Villa Sofia
Palermo
AOU di Parma
Parma
Fondazione IRCCS S. Matteo
Pavia
S.C. Ematologia Ospedale S. Marid Della Misericordia
Perugia
Ospedale Civile di Pescara
Pescara
Ospedale Civico Guglielmo di Saliceto
Piacenza
Ospedale San Carlo di Potenza
Potenza
U.O. Oncologia Ematologia Ospedale S. Maria Delle Croci
Ravenna
A.O. Bianchi-Melacrino-Morelli, Divisione di Ematologia
Reggio Calabria
ICCRS Azienda Ospedaliera Arcipedale "Santa Maria Nuova"
Reggio Emilia
Ospedale Degli Infermi
Rimini
Fondazione PTV Policlinico Tor Vergata
Roma, 00133
AO San Camillo Forlanini
Roma
AOU S. Andrea Roma
Roma
Ospedale S. Eugenio
Roma
Policlinico Universitario Campus Bio-Medico
Roma
Roma Regina Elena IFO
Roma
Roma San Giovanni
Roma
Università degli Studi La Sapienza
Roma
Rozzano Humanitas
Rozzano
Siena
Siena
AOS Maria di Terni
Terni
AOS S. Giovanni Battista "Molinette"
Torino
Azienda Ospedaliera Citta Della Salute E Della Scienza Di Torino
Torino
Ospedale Cardinale Panico
Tricase
Azienda Ospedaliera Univesritaria
Udine
Asst Settelaghi Ospedale Macchi
Varese
United Kingdom12 sites
Basingstoke & North Hamptshire Hospital
Basingstoke
Birmingham Heartlands Hospital
Birmingham
Glasgow Beatson Cancer Center
Glasgow
Leeds St. James's Hospital
Leeds
Royal Liverpool University Hospital
Liverpool
Guy's & St. Thomas London
London
UCLH St. Thomas
London
Manchester The Christie NHS Foundation Trust
Manchester
Newcastle Freeman Hospital
Newcastle
Norfolk & Norwich University Hospital
Norfolk
Nottingham University Hospital
Nottingham
General Hospital
Southampton
Czechia4 sites
Faculty Hospital Brno
Brno
University Hospital
Hradec Králové
Faculty Hospital Kralovske Vinohrady
Prague
General University Hospital
Prague
Switzerland4 sites
IOSI
Bellinzona, 6500
Inselspital Bern
Bern
Kantonsspital Olten
Olten
Kantonsspital
Sankt Gallen
United States3 sites
MD Anderson Cancer Center
Houston, Texas
Norton Cancer Institute
Louisville, Kentucky
Mayo Clinil Rocheser
Rochester, Minnesota, 55905
About this study
Official title: IELSG37: A Randomized, Open-label, Multicentre, Two-arm 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 (PMLBCL)
Primary mediastinal large B cell lymphoma is treated with a combination of chemotherapy and the monoclonal antibody rituximab (chemoimmunotherapy).
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.
Read more
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.
- Conditions
- Primary Mediastinal B-cell Lymphoma
- Being tested
- observation, 3D-Conformal Radiotherapy (3D-CRT)
- Keywords
- previously, untreated
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
observationOther
observation
3D-Conformal Radiotherapy (3D-CRT)Radiation
Radiation treatment should start within 6-8 weeks after the end of chemotherapy.
| Study group | Role | What they receive |
|---|---|---|
| observation | Experimental | 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. Receives: Other: observation |
| mediastinal irradiation | Active comparator | 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. Receives: Radiation: 3D-Conformal Radiotherapy (3D-CRT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival (PFS)
The primary outcome endpoint will be Progression Free Survival (PFS) in patients PET-negative after R-chemotherapy.
Failure events for PFS are progression (defined as an increase in size of existing masses or the development of new sites of disease using the same radiological investigations CT or PET/CT and/or MRI - as for the pre-chemotherapy assessment) or death from any cause.
Measured: 30 months from the randomization
Secondary outcomes (2)
Overall survival (OS)
OS is defined as the time from registration until death as a result of any cause until five years from registration
Measured: 5 years from registration
Long term toxicity
Reporting of any adverse event which is judged in the opinion of investigator to be possibly treatment-related up to 10 years from randomization (including all cardiac and pulmonary events, relapses and second cancers and deaths)
Measured: 10 years from registration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2012 (estimated)
- Study startOct 2012
- Primary completion17 Jun 2022
- Study completion17 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Primary Mediastinal B-cell LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 540 participants (estimated)
Sponsor and investigators
- Lead sponsor
- International Extranodal Lymphoma Study Group (IELSG)
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maurizio Martelli, MD, Study chair, Università La Sapienza (Rome - Italy)Andrew J Davies, MD, Study chair, University of Southampton (UK)Mary Gospodarowicz, MD, Study chair, Princess Margaret Hospital Toronto (Canada)Sally F Barrington, MD, Study chair, St. Thomas' - London (UK)Alberto Biggi, MD, Study chair, AO S. Croce e Carle, Cuneo (Italia)Annibale Versari, MD, Study chair, S.Maria Nuova Hospital, Reggio Emilia (Italia)Gianni Ciccone, MD, Study chair, CPO Torino (Italy)Stèphane Chauvie, MD, Study chair, AO S. Crtoce e Carle - Cuneo (Italy)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01599559
- Sponsor's protocol ID
- IELSG37
- Status last verified
- Jan 2026
- First submitted
- 10 May 2012
- Last updated
- 15 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 40939190Martelli 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.
PubMed 39159403
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IELSG37: A Randomized, Open-label, Multicentre, Two-arm 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 (PMLBCL)
- ClinicalTrials.gov ID
- NCT01599559
- Acronym / sponsor ID
- IELSG37
- Conditions
- Primary Mediastinal B-cell Lymphoma
- Keywords
- previously, untreated
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 540 participants (estimated)
- Lead sponsor
- International Extranodal Lymphoma Study Group (IELSG)University, hospital or other
- Study start
- Oct 2012 (actual)
- Primary completion
- 17 Jun 2022 (actual)
- Study completion
- 17 Dec 2029 (estimated)
- First posted
- 16 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Primary mediastinal large B cell lymphoma is treated with a combination of chemotherapy and the monoclonal antibody rituximab (chemoimmunotherapy).
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| observation | Experimental | Other: observationFollow 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. |
| mediastinal irradiation | Active comparator | Radiation: 3D-Conformal Radiotherapy (3D-CRT)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Previously untreated primary mediastinal diffuse large B-cell lymphoma, CD20 positive.
- 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.
Key exclusion criteria (5 listed)
- History of malignancy other than squamous cell carcinoma, basal cell carcinoma of the skin or carcinoma in situ of the cervix within the last 5 years.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| observationobservation | Other | observation |
| 3D-Conformal Radiotherapy (3D-CRT)Radiation treatment should start within 6-8 weeks after the end of chemotherapy. | Radiation | mediastinal irradiation |
Primary outcome
Progression free survival (PFS)
Time frame: 30 months from the randomization
The primary outcome endpoint will be Progression Free Survival (PFS) in patients PET-negative after R-chemotherapy. Failure events for PFS are progression (defined as an increase in size of existing masses or the development of new sites of disease using the same radiological investigations CT or PET/CT and/or MRI - as for the pre-chemotherapy assessment) or death from any cause.
2 secondary outcomes
Overall survival (OS)
Time frame: 5 years from registration
Long term toxicity
Time frame: 10 years from registration
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2026.
- Derived from this study: PubMed 40939190Zucca 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.
- Derived from this study: PubMed 39159403Martelli 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maurizio Martelli, MD study chair
Università La Sapienza (Rome - Italy)
Andrew J Davies, MD study chair
University of Southampton (UK)
Mary Gospodarowicz, MD study chair
Princess Margaret Hospital Toronto (Canada)
85 sites in 14 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing observation and 3D-Conformal Radiotherapy (3D-CRT) in people with Primary Mediastinal B-cell Lymphoma, run by International Extranodal Lymphoma Study Group (IELSG) at 85 sites in 14 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 15 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 85 sites in Italy, United Kingdom, Czechia, Switzerland, United States and 9 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression free survival (PFS) (time frame: 30 months from the randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01599559, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2026.