Prognosis Of Patients With Aggressive B-Cell Lymphoma, Treated With Rituximab+Anthracycline Regimen (ProDLBCL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01478269
Recruitment Status : Completed
First Posted : November 23, 2011
Last Update Posted : November 23, 2011
Information provided by (Responsible Party):
Fondazione Italiana Linfomi ONLUS

Brief 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.

Condition or disease
B-Cell Lymphomas

Study Type : Observational
Actual Enrollment : 1927 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Prognosis Of Patients With Aggressive B-Cell Lymphoma, Treated With Rituximab+Anthracycline Regimen (ProDLBCL)
Study Start Date : May 2009
Actual Primary Completion Date : May 2011
Actual Study Completion Date : May 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma
Drug Information available for: Rituximab

Cases of aggressive B-cell lymphoma
Cases of aggressive B-cell lymphoma diagnosed between 2001 to 2007 in Italy

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Cases of aggressive B-cell lymphoma diagnosed between 2001 to 2007 in Italy

Inclusion Criteria:

  1. Histologically confirmed newly diagnosed aggressive B-cell lymphoma according to the current World Health Organisation Classification, from 2001 to 2007.
  2. Any stage of disease.
  3. Treatment with R-CHOP or R-CHOP like regimens (+/- transplant).
  4. Age at least 18 years.
  5. Availability of tissue biopsy at diagnosis for a possible centralized revision.
  6. Availability of data on clinical involvement, laboratory, treatment and follow up.

Exclusion Criteria:

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01478269

Campinas, Brazil
Centro Medico
Santa Isabel, Brazil
Centro Paulista de Oncologia
Sao Paolo, Brazil
Santa Casa Medical School
Sao Paolo, Brazil
A.O.SS. Biagio, Antonio e Cesare Arrigo
Alessandria, Italy
Centro di riferimento Oncologico Oncologia Medica A
Aviano (Pordenone), Italy
USC Ematologia e Trapianto di Midollo Osseo Ospedali Riuniti di Bergamo
Bergamo, Italy
Presidio Ospedaliero A.Perrino - Divisione di Ematologia
Brindisi, Italy
U.O. di Oncologia Ospedale di Circolo di Busto Arsizio
Busto Arsizio, Italy
Ospedale Civile
Camposanpiero (PD), Italy
A.O.Pugliese Ciaccio Diviisone di Ematologia
Catanzaro, Italy
Presidio Ospedaliero Annunziata U.O.C. di Ematologia
Cosenza, Italy
Clinica Ematologica Policlinico Carreggi
Firenze, Italy, 50134
Ematologia 1 Ospedale S. Martino
Genova, Italy, 16132
Oncologia Medica B e C IST Genova
Genova, Italy
Ospedale Felettino
La Spezia, Italy
Ospedale Madonna delle grazie U.O. Ematologia
Matera, Italy
A O Papardo
Messina, Italy
Azienda Ospedaliero Universitaria Policlinico Gaetano Martino
Messina, Italy
Ematologia e Trapianto IRCCS, Istituto Nazionale dei Tumori
Milano, Italy
Oncologia Medica 3 Istituto Nazionale dei Tumori di Milano
Milano, Italy
Osp. San Carlo Borromeo Divisione di Oncologia Medica
Milano, Italy
Ospedale Maggiore IRCCS-Dipartimento di Ematologia
Milano, Italy
Centro Oncologico Modenese
Modena, Italy
A.O. Maggiore della Carità S.C.D.U. Ematologia
Novara, Italy
A.O. di Padova Divisione di Oncologia Medica
Padova, Italy
Casa di cura La Maddalena Unita' di Ematologia
Palermo, Italy
Div. di Ematologia e TMO AOU Policlinico Giaccone di Palermo
Palermo, Italy
A O Universitaria di Parma
Parma, Italy
Ospedale Civile G.da Saliceto - UOA Ematologia
Piacenza, Italy
Azienda Ospedaliero Universitaria Pisana U.O. Ematologia
Pisa, Italy
AO Bianchi Melacrino Morelli UO Ematologia
Reggio Calabria, Italy
AO Arcispedale S.Maria Nuova Ematologia
Reggio Emilia, Italy
Ospedale Oncologico regionale CROB
Rionero in Vulture (PZ), Italy
Dipartimento di biotecnologie cellulari ed ematologia Ospedale Umberto I - La Sapienza
Roma, Italy
Policlinico A. Gemelli Università Cattolica del Sacro Cuore
Roma, Italy
Clinica Humanitas
Rozzano (MI), Italy
A.O.San Giovanni Battista
Torino, Italy
U.O. Oncologia Azienda ULSS7 P.O. di Vittorio Veneto
Vittorio Veneto, Italy
Sponsors and Collaborators
Fondazione Italiana Linfomi ONLUS
Study Director: Massimo Federico, MD Oncologia II Azienda Ospedaliera Universitaria di Modena
Principal Investigator: Stefano Luminari, MD Oncologia II Azienda Ospedaliera Universitaria di Modena

Responsible Party: Fondazione Italiana Linfomi ONLUS Identifier: NCT01478269     History of Changes
Other Study ID Numbers: IIL_ProDLBCL
First Posted: November 23, 2011    Key Record Dates
Last Update Posted: November 23, 2011
Last Verified: November 2011

Keywords provided by Fondazione Italiana Linfomi ONLUS:
Aggressive B-cell lymphoma

Additional relevant MeSH terms:
Lymphoma, B-Cell
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Behavioral Symptoms
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents