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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Fondazione Italiana Linfomi ONLUS
ClinicalTrials.gov Identifier:
NCT01478269
First received: October 12, 2011
Last updated: November 22, 2011
Last verified: November 2011
History of Changes
  Purpose

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
B-Cell Lymphomas

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Prognosis Of Patients With Aggressive B-Cell Lymphoma, Treated With Rituximab+Anthracycline Regimen (ProDLBCL)

Resource links provided by NLM:

MedlinePlus related topics: Lymphoma
Drug Information available for: Rituximab
U.S. FDA Resources

Further study details as provided by Fondazione Italiana Linfomi ONLUS:

Enrollment: 1927
Study Start Date: May 2009
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Cases of aggressive B-cell lymphoma
Cases of aggressive B-cell lymphoma diagnosed between 2001 to 2007 in Italy

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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:

  • None
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01478269

Locations
Brazil
Hemocentro-Unicamp
Campinas, Brazil
Centro Medico
Santa Isabel, Brazil
Centro Paulista de Oncologia
Sao Paolo, Brazil
Santa Casa Medical School
Sao Paolo, Brazil
Italy
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
Oncologia Medica B e C IST Genova
Genova, Italy
Ematologia 1 Ospedale S. Martino
Genova, Italy, 16132
Ospedale Felettino
La Spezia, Italy
Ospedale Madonna delle grazie U.O. Ematologia
Matera, Italy
Azienda Ospedaliero Universitaria Policlinico Gaetano Martino
Messina, Italy
A O Papardo
Messina, Italy
Ematologia e Trapianto IRCCS, Istituto Nazionale dei Tumori
Milano, Italy
Ospedale Maggiore IRCCS-Dipartimento di Ematologia
Milano, Italy
Osp. San Carlo Borromeo Divisione di Oncologia Medica
Milano, Italy
Oncologia Medica 3 Istituto Nazionale dei Tumori di Milano
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
Div. di Ematologia e TMO AOU Policlinico Giaccone di Palermo
Palermo, Italy
Casa di cura La Maddalena Unita' di Ematologia
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
Policlinico A. Gemelli Università Cattolica del Sacro Cuore
Roma, Italy
Dipartimento di biotecnologie cellulari ed ematologia Ospedale Umberto I - La Sapienza
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
Investigators
Study Director: Massimo Federico, MD Oncologia II Azienda Ospedaliera Universitaria di Modena
Principal Investigator: Stefano Luminari, MD Oncologia II Azienda Ospedaliera Universitaria di Modena
  More Information

No publications provided

Responsible Party: Fondazione Italiana Linfomi ONLUS
ClinicalTrials.gov Identifier: NCT01478269     History of Changes
Other Study ID Numbers: IIL_ProDLBCL
Study First Received: October 12, 2011
Last Updated: November 22, 2011
Health Authority: Italy: The Italian Medicines Agency

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

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

ClinicalTrials.gov processed this record on May 19, 2013