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

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.

Study Overview

• Status: Completed
• Conditions: B-Cell Lymphomas

• Study Type: Observational
• Enrollment (Actual): 1927

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Cases of aggressive B-cell lymphoma; Cases of aggressive B-cell lymphoma diagnosed between 2001 to 2007 in Italy

Collaborators and Investigators

• Sponsor: 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

Study record dates

Study Major Dates

• Study Start: May 1, 2009
• Primary Completion (Actual): May 1, 2011
• Study Completion (Actual): May 1, 2011

Study Registration Dates

• First Submitted: October 12, 2011
• First Submitted That Met QC Criteria: November 22, 2011
• First Posted (Estimate): November 23, 2011

Study Record Updates

• Last Update Posted (Estimate): November 23, 2011
• Last Update Submitted That Met QC Criteria: November 22, 2011
• Last Verified: November 1, 2011

More Information

Terms related to this study

• Keywords: R-CHOP; Aggressive B-cell lymphoma
• Additional Relevant MeSH Terms: Behavioral Symptoms; Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Aggression; Lymphoma; Lymphoma, B-Cell
• Other Study ID Numbers: IIL_ProDLBCL