Primary Mediastinal B-Cell LymphomaNCT00944567
A Clinico-Pathologic Study of Primary Mediastinal B-Cell Lymphoma
An observational study of Primary Mediastinal B-Cell Lymphoma, run by International Extranodal Lymphoma Study Group (IELSG) at 20 sites in 4 countries.
Trial summary
A non-profit study designed with the aim of analysing the phenotype and molecular characteristics (central review) and evaluating prospectively the role of PET-scans in the management of primary mediastinal lymphoma treated with conventional approaches. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Mediastinal B-Cell Lymphoma
- How many people
- 125 participants
- Where
- 20 sitesin 4 countries
- Study dates
- Jan 2007to 27 Feb 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: patient must have histological confirmation of the diagnodis of primary mediastinal diffuse large B cell lymphoma and have a dominant mass within the anterior mediastinum
Who may be able to join
- Primary mediastinal diffuse large B-cell lymphoma, CD20 positive. Patients must have histological confirmation of the diagnosis, and in addition have a dominant mass within the anterior mediastinum.
- No prior treatment of lymphoma. Patients may have received corticosteroids for up to 1 week for the relief of local compressive symptoms.
- Any stage of disease.
- Age at least 18 years.
- Fit to receive chemotherapy with curative intent.
- 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.
Who cannot join
- 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. Cardiac compromise due to local extension of lymphoma will not be an exclusion criterion in the absence of other cardiac disease.
- Impairment of bone marrow function (WBC <3.0x109/L, ANC <1.5x109/L, PLT <100x109/L), unless due to involvement by lymphoma.
- Major impairment of renal function (serum creatinine >2x upper normal) or liver function (ASAT/ALAT >2,5 upper normal, total bilirubin >2,5x upper normal), unless due to lymphoma involvement.
- Known HIV infection. Patients will not be tested routinely.
- Pregnant or lactating women.
- Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
Trial locations and contacts
20 sites in 4 countries.
20 sites in 4 countries
Italy16 sites
A.O. SS. Antonio e Biagio e Cesare Arrigo
Alessandria
IRCCS Ospedale Oncologico
Bari
Policlinico S. Orsola Malpighi
Bologna
Ospedale Oncologico
Cagliari
Policlinico Careggi
Florence
A.O.Papardo
Messina
Ospedale Niguarda Ca' Granda
Milan
Ospedale San Raffaele
Milan
Università di Modena, Policlinico
Modena
Policlinico S. Matteo
Pavia
A.O. Bianchi-Melacrino-Morelli
Reggio Calabria
Arcispedale S. Maria Nuova
Reggio Emilia
Università di Roma "La Sapienza" - DAI Ematologia
Rome, 00161
Humanitas
Rozzano
Ospedale Maggiore San Giovanni Battista
Torino
Ospedale di Circolo Fondazione Macchi
Varese
United Kingdom2 sites
Barts & the London NHS Trust
London
Royal Marsden NHS Foundation Trust
London
About this study
A non-profit study designed with the aim of analysing the phenotype and molecular characteristics (central review) and evaluating prospectively the role of PET-scans in the management of primary mediastinal lymphoma treated with conventional approaches.
- Conditions
- Primary Mediastinal B-Cell Lymphoma
- Keywords
- Primary Mediastinal B-Cell Lymphoma, Positron emission tomography
What is being measured
The primary outcome is the main question the study is designed to answer.
response rate on PET scanning following initial chemo-immunotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2009 (estimated)
- Study startJan 2007
- Primary completionMay 2011
- Study completion27 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- International Extranodal Lymphoma Study Group (IELSG)
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00944567
- Sponsor's protocol ID
- IELSG26
- Other IDs
- EudraCT number 2006-005794-22
- Status last verified
- Aug 2017
- First submitted
- 22 Jul 2009
- Last updated
- 15 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Ceriani L, Milan L, Martelli M, Ferreri AJM, Cascione L, Zinzani PL, Di Rocco A, Conconi A, Stathis A, Cavalli F, Bellei M, Cozens K, Porro E, Giovanella L, Johnson PW, Zucca E. Metabolic heterogeneity on baseline 18FDG-PET/CT scan is a predictor of outcome in primary mediastinal B-cell lymphoma. Blood. 2018 Jul 12;132(2):179-186. doi: 10.1182/blood-2018-01-826958. Epub 2018 May 2.
PubMed 29720487Ceriani L, Martelli M, Zinzani PL, Ferreri AJ, Botto B, Stelitano C, Gotti M, Cabras MG, Rigacci L, Gargantini L, Merli F, Pinotti G, Mannina D, Luminari S, Stathis A, Russo E, Cavalli F, Giovanella L, Johnson PW, Zucca E. Utility of baseline 18FDG-PET/CT functional parameters in defining prognosis of primary mediastinal (thymic) large B-cell lymphoma. Blood. 2015 Aug 20;126(8):950-6. doi: 10.1182/blood-2014-12-616474. Epub 2015 Jun 18.
PubMed 26089397Martelli M, Ceriani L, Zucca E, Zinzani PL, Ferreri AJ, Vitolo U, Stelitano C, Brusamolino E, Cabras MG, Rigacci L, Balzarotti M, Salvi F, Montoto S, Lopez-Guillermo A, Finolezzi E, Pileri SA, Davies A, Cavalli F, Giovanella L, Johnson PW. [18F]fluorodeoxyglucose positron emission tomography predicts survival after chemoimmunotherapy for primary mediastinal large B-cell lymphoma: results of the International Extranodal Lymphoma Study Group IELSG-26 Study. J Clin Oncol. 2014 Jun 10;32(17):1769-75. doi: 10.1200/JCO.2013.51.7524. Epub 2014 May 5.
PubMed 24799481
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinico-Pathologic Study of Primary Mediastinal B-Cell Lymphoma
- ClinicalTrials.gov ID
- NCT00944567
- Acronym / sponsor ID
- IELSG26
- Conditions
- Primary Mediastinal B-Cell Lymphoma
- Keywords
- Primary Mediastinal B-Cell Lymphoma, Positron emission tomography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- International Extranodal Lymphoma Study Group (IELSG)University, hospital or other
- Study start
- Jan 2007
- Primary completion
- May 2011 (actual)
- Study completion
- 27 Feb 2017 (actual)
- First posted
- 23 Jul 2009 (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.
A non-profit study designed with the aim of analysing the phenotype and molecular characteristics (central review) and evaluating prospectively the role of PET-scans in the management of primary mediastinal lymphoma treated with conventional approaches.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patient must have histological confirmation of the diagnodis of primary mediastinal diffuse large B cell lymphoma and have a dominant mass within the anterior mediastinum
Key inclusion criteria (7 listed)
- Primary mediastinal diffuse large B-cell lymphoma, CD20 positive. Patients must have histological confirmation of the diagnosis, and in addition have a dominant mass within the anterior mediastinum.
- No prior treatment of lymphoma. Patients may have received corticosteroids for up to 1 week for the relief of local compressive symptoms.
- Any stage of disease.
- Age at least 18 years.
- Fit to receive chemotherapy with curative intent.
Key exclusion criteria (6 listed)
- 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. Cardiac compromise due to local extension of lymphoma will not be an exclusion criterion in the absence of other cardiac disease.
- Impairment of bone marrow function (WBC <3.0x109/L, ANC <1.5x109/L, PLT <100x109/L), unless due to involvement by lymphoma.
- Major impairment of renal function (serum creatinine >2x upper normal) or liver function (ASAT/ALAT >2,5 upper normal, total bilirubin >2,5x upper normal), unless due to lymphoma involvement.
- Known HIV infection. Patients will not be tested routinely.
- Pregnant or lactating women.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
response rate on PET scanning following initial chemo-immunotherapy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2017.
- Derived from this study: PubMed 29720487Ceriani L, Milan L, Martelli M, Ferreri AJM, Cascione L, Zinzani PL, Di Rocco A, Conconi A, Stathis A, Cavalli F, Bellei M, Cozens K, Porro E, Giovanella L, Johnson PW, Zucca E. Metabolic heterogeneity on baseline 18FDG-PET/CT scan is a predictor of outcome in primary mediastinal B-cell lymphoma. Blood. 2018 Jul 12;132(2):179-186. doi: 10.1182/blood-2018-01-826958. Epub 2018 May 2.
- Derived from this study: PubMed 26089397Ceriani L, Martelli M, Zinzani PL, Ferreri AJ, Botto B, Stelitano C, Gotti M, Cabras MG, Rigacci L, Gargantini L, Merli F, Pinotti G, Mannina D, Luminari S, Stathis A, Russo E, Cavalli F, Giovanella L, Johnson PW, Zucca E. Utility of baseline 18FDG-PET/CT functional parameters in defining prognosis of primary mediastinal (thymic) large B-cell lymphoma. Blood. 2015 Aug 20;126(8):950-6. doi: 10.1182/blood-2014-12-616474. Epub 2015 Jun 18.
- Derived from this study: PubMed 24799481Martelli M, Ceriani L, Zucca E, Zinzani PL, Ferreri AJ, Vitolo U, Stelitano C, Brusamolino E, Cabras MG, Rigacci L, Balzarotti M, Salvi F, Montoto S, Lopez-Guillermo A, Finolezzi E, Pileri SA, Davies A, Cavalli F, Giovanella L, Johnson PW. [18F]fluorodeoxyglucose positron emission tomography predicts survival after chemoimmunotherapy for primary mediastinal large B-cell lymphoma: results of the International Extranodal Lymphoma Study Group IELSG-26 Study. J Clin Oncol. 2014 Jun 10;32(17):1769-75. doi: 10.1200/JCO.2013.51.7524. Epub 2014 May 5.
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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.
The record lists no contact. Use the official record to reach the sponsor.
20 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Primary Mediastinal B-Cell Lymphoma, run by International Extranodal Lymphoma Study Group (IELSG) at 20 sites in 4 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 7 inclusion and 6 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: finished, as of the sponsor's last update on 15 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in Italy, United Kingdom, Spain, Switzerland. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
response rate on PET scanning following initial chemo-immunotherapy. 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 NCT00944567, which also lists 3 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 Aug 2017.