B-Cell LymphomasProDLBCLNCT01478269
Prognosis Of Patients With Aggressive B-Cell Lymphoma, Treated With Rituximab+Anthracycline Regimen
An observational study of B-Cell Lymphomas, run by Fondazione Italiana Linfomi - ETS at 39 sites in 2 countries.
Trial summary
This study is a retrospective analysis of an homogeneous population of patients with aggressive B-cell lymphoma and treated upfront with R-CHOP or R-CHOP like regimens to reassess the prognostic factors and hopefully to identify more accurate prognostic subgroups with a clinical and therapeutical relevance. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- B-Cell Lymphomas
- How many people
- 1,927 participants
- Where
- 39 sitesin 2 countries
- Study dates
- May 2009to May 2011
- 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: Cases of aggressive B-cell lymphoma diagnosed between 2001 to 2007 in Italy
Who may be able to join
- Histologically confirmed newly diagnosed aggressive B-cell lymphoma according to the current World Health Organisation Classification, from 2001 to 2007.
- Any stage of disease.
- Treatment with R-CHOP or R-CHOP like regimens (+/- transplant).
- Age at least 18 years.
- Availability of tissue biopsy at diagnosis for a possible centralized revision.
- Availability of data on clinical involvement, laboratory, treatment and follow up.
Who cannot join
- None
Trial locations and contacts
39 sites in 2 countries.
39 sites in 2 countries
Italy35 sites
A.O.SS. Biagio, Antonio e Cesare Arrigo
Alessandria
Centro di riferimento Oncologico Oncologia Medica A
Aviano (Pordenone)
USC Ematologia e Trapianto di Midollo Osseo Ospedali Riuniti di Bergamo
Bergamo
Presidio Ospedaliero A.Perrino - Divisione di Ematologia
Brindisi
U.O. di Oncologia Ospedale di Circolo di Busto Arsizio
Busto Arsizio
Ospedale Civile
Camposanpiero (PD)
A.O.Pugliese Ciaccio Diviisone di Ematologia
Catanzaro
Presidio Ospedaliero Annunziata U.O.C. di Ematologia
Cosenza
Clinica Ematologica Policlinico Carreggi
Florence, Firenze, 50134
Ematologia 1 Ospedale S. Martino
Genova, 16132
Oncologia Medica B e C IST Genova
Genova
Ospedale Felettino
La Spezia
Ospedale Madonna delle grazie U.O. Ematologia
Matera
A O Papardo
Messina
Azienda Ospedaliero Universitaria Policlinico Gaetano Martino
Messina
Ematologia e Trapianto IRCCS, Istituto Nazionale dei Tumori
Milan, Milano
Oncologia Medica 3 Istituto Nazionale dei Tumori di Milano
Milan
Osp. San Carlo Borromeo Divisione di Oncologia Medica
Milan
Ospedale Maggiore IRCCS-Dipartimento di Ematologia
Milan
Centro Oncologico Modenese
Modena
A.O. Maggiore della Carità S.C.D.U. Ematologia
Novara
A.O. di Padova Divisione di Oncologia Medica
Padova
Casa di cura La Maddalena Unita' di Ematologia
Palermo
Div. di Ematologia e TMO AOU Policlinico Giaccone di Palermo
Palermo
A O Universitaria di Parma
Parma
Ospedale Civile G.da Saliceto - UOA Ematologia
Piacenza
Azienda Ospedaliero Universitaria Pisana U.O. Ematologia
Pisa
AO Bianchi Melacrino Morelli UO Ematologia
Reggio Calabria
AO Arcispedale S.Maria Nuova Ematologia
Reggio Emilia
Ospedale Oncologico regionale CROB
Rionero in Vulture (PZ)
Dipartimento di biotecnologie cellulari ed ematologia Ospedale Umberto I - La Sapienza
Roma
Policlinico A. Gemelli Università Cattolica del Sacro Cuore
Roma
Clinica Humanitas
Rozzano (MI)
A.O.San Giovanni Battista
Torino
U.O. Oncologia Azienda ULSS7 P.O. di Vittorio Veneto
Vittorio Veneto
Brazil4 sites
Hemocentro-Unicamp
Campinas
Centro Medico
Santa Isabel
Centro Paulista de Oncologia
São Paulo
Santa Casa Medical School
São Paulo
About this study
Official title: Prognosis Of Patients With Aggressive B-Cell Lymphoma, Treated With Rituximab+Anthracycline Regimen (ProDLBCL)
This study is a retrospective analysis of an homogeneous population of patients with aggressive B-cell lymphoma and treated upfront with R-CHOP or R-CHOP like regimens to reassess the prognostic factors and hopefully to identify more accurate prognostic subgroups with a clinical and therapeutical relevance.
- Conditions
- B-Cell Lymphomas
- Keywords
- Aggressive B-cell lymphoma, R-CHOP
- Medical subject headings
- Lymphoma, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cases of aggressive B-cell lymphoma | Cases of aggressive B-cell lymphoma diagnosed between 2001 to 2007 in Italy |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2011 (estimated)
- Study startMay 2009
- Primary completionMay 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for B-Cell LymphomasStudies 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
- Retrospective
- Enrolment
- 1,927 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondazione Italiana Linfomi - ETS
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Massimo Federico, MD, Study director, Oncologia II Azienda Ospedaliera Universitaria di ModenaStefano Luminari, MD, Principal investigator, Oncologia II Azienda Ospedaliera Universitaria di Modena
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01478269
- Sponsor's protocol ID
- IIL_ProDLBCL
- Acronym
- ProDLBCL
- Status last verified
- Nov 2011
- First submitted
- 12 Oct 2011
- Last updated
- 23 Nov 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognosis Of Patients With Aggressive B-Cell Lymphoma, Treated With Rituximab+Anthracycline Regimen (ProDLBCL)
- ClinicalTrials.gov ID
- NCT01478269
- Acronym / sponsor ID
- ProDLBCL / IIL_ProDLBCL
- Conditions
- B-Cell Lymphomas
- Keywords
- Aggressive B-cell lymphoma, R-CHOP
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,927 participants (actual)
- Lead sponsor
- Fondazione Italiana Linfomi - ETSUniversity, hospital or other
- Study start
- May 2009
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 23 Nov 2011 (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.
This study is a retrospective analysis of an homogeneous population of patients with aggressive B-cell lymphoma and treated upfront with R-CHOP or R-CHOP like regimens to reassess the prognostic factors and hopefully to identify more accurate prognostic subgroups with a clinical and therapeutical relevance.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cases of aggressive B-cell lymphoma | – | –Cases of aggressive B-cell lymphoma diagnosed between 2001 to 2007 in Italy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Cases of aggressive B-cell lymphoma diagnosed between 2001 to 2007 in Italy
Key inclusion criteria (6 listed)
- Histologically confirmed newly diagnosed aggressive B-cell lymphoma according to the current World Health Organisation Classification, from 2001 to 2007.
- Any stage of disease.
- Treatment with R-CHOP or R-CHOP like regimens (+/- transplant).
- Age at least 18 years.
- Availability of tissue biopsy at diagnosis for a possible centralized revision.
Key exclusion criteria (1 listed)
- None
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
Not reported in the source record.
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 23 Nov 2011.
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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.
Massimo Federico, MD study director
Oncologia II Azienda Ospedaliera Universitaria di Modena
Stefano Luminari, MD principal investigator
Oncologia II Azienda Ospedaliera Universitaria di Modena
39 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of B-Cell Lymphomas, run by Fondazione Italiana Linfomi - ETS at 39 sites in 2 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 6 inclusion and 1 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 23 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 39 sites in Italy, Brazil. 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.
Where can I read the original study information?
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 23 Nov 2011.