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R-CHOP14 or R-CHOP21 &Consolidation PET-Oriented Radiotherapy (RT) in DLBCL Patients (FIL_DLCL10)

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ClinicalTrials.gov Identifier: NCT03364439
Recruitment Status : Recruiting
First Posted : December 6, 2017
Last Update Posted : December 6, 2017
Information provided by (Responsible Party):
Fondazione Italiana Linfomi ONLUS

Brief Summary:
Prospective, multicentre phase II study with R-CHOP- 14 or R-CHOP-21 & consolidation PET-oriented radiotherapy (RT) in diffuse large B cell lymphoma (DLBCL) patients

Condition or disease Intervention/treatment Phase
Diffuse Large B Cell Lymphoma Drug: Treatment plan Phase 2

Detailed Description:
Prospective, multicentre phase II study with R-CHOP- 14 or R-CHOP-21 & consolidation PET-oriented radiotherapy (RT) in diffuse large B cell lymphoma (DLBCL) patients with low risk profile according to age-adjusted IPI (0 with bulky or 1)

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 112 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective, Multicentre Phase II Study With R-CHOP- 14 or R-CHOP-21 & Consolidation PET-Oriented Radiotherapy (RT) in Diffuse Large B Cell Lymphoma (DLBCL) Patients With Low Risk Profile According to Age-adjusted IPI (0 With Bulky or 1)
Study Start Date : January 2012
Estimated Primary Completion Date : January 2018
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma
U.S. FDA Resources

Arm Intervention/treatment
Experimental: One arm for all patients
Patients eligible for the study will receive 6 courses of R-CHOP14 or R-CHOP21.
Drug: Treatment plan
R-CHOP14 or R-CHOP21 for 6 cycles Restaging after 2, 4, 6 cycles Consolidation therapy with RT (36 Gy) if PET positive (PET after 6 R-CHOP cycles)

Primary Outcome Measures :
  1. PFS Progression Free Survival [ Time Frame: 24 months ]
    defined as non response after 4 or 6 cycles of chemotherapy or progression of disease after consolidation RT or at any time of therapy, relapse or death from any cause.

Secondary Outcome Measures :
  1. OS Overall Survival [ Time Frame: 48 months ]
    OS will be defined as the time between the date of initiation of therapy and the date of death from any cause or the date of last follow up

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Histological diagnosis of DLBCL (CD20+), follicular lymphoma grade IIIB, T-cell rich large B cell lymphoma
  • Age 18-80 years (patients >70 years old: FIT according to VGM evaluation).
  • aaIPI=1 +/- bulky and aaIPI=0 with bulky (>7.5 cm)
  • ECOG-PS < 3 unless due to lymphoma
  • Ventricular ejection fraction ≥ 50%
  • Pulmonary, renal and hepatic tests within normal range
  • Negative HIV and HBV tests. In case of HBcAb positive and HBsAb +/-, which is indicative of a past infection (occult carriers) the subject can be included, but antiviral prophylaxis with lamivudine must be given from the beginning of treatment until 12 months after treatment completion. Anti-HCV positive patients can be included in the absence of viral replication (HVR-RNA absent or less than 500 copies/ml.
  • Written informed consent
  • Life-expectancy > 3 months

Main Exclusion Criteria:

  • T-cell lymphoma
  • Follicular lymphoma (grade I, II, IIIA), marginal zone and mantle lymphoma
  • PS> 3 (if not due to lymphoma)
  • Age-adjusted IPI = 0 in the absence of bulky disease
  • Age> 80 and <18 years (see inclusion criteria)
  • HIV positivity
  • significant cardiopathy

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 ClinicalTrials.gov identifier (NCT number): NCT03364439

Contact: Uffici Studi FIL Fondazione Italiana Linfomi 0039 ext 0131206288

U.O.C. Garibaldi Nesima Active, not recruiting
Catania, CT, Italy, 95125
A.O. Niguarda Recruiting
Milano, MI, Italy, 20162
Contact: Chiara Rusconi, MD    +39 02 - 64442668    chiara.rusconi@ospedaleniguarda.it   
Principal Investigator: Chiara Rusconi, MD         
AO Ospedali Riuniti Villa Sofia - Cervello (Presidio Cervello) Not yet recruiting
Palermo, PA, Italy, 90146
Contact: Caterina Patti, MD    0039 0917803162    kpatti@ospedaliriunitipalermo.it   
Principal Investigator: Caterina Patti, MD         
Centro di Riferimento Oncologico della Basilicata Recruiting
Rionero in Vulture, PZ, Italy, 85028
Contact: Pellegrino Musto       pellegrino.musto@crob.it   
Principal Investigator: Pellegrino Musto, MD         
A.O. SS. Antonio e Biagio e C. Arrigo Recruiting
Alessandria, Italy, 15121
Contact: Flavia Salvi, MD    +39 0131206440    flaviasalvi@hotmail.com   
Principal Investigator: Flavia Salvi, MD         
A.O. Universitaria Ospedali Riuniti - Ospedale Umberto I Di Ancona Recruiting
Ancona, Italy, 60126
Contact: Guido Gini       g.gini@ospedaliriuniti.marche.it   
Principal Investigator: Guido Gini, MD         
Centro di riferimento Oncologico Oncologia Medica A Recruiting
Aviano, Italy
Contact: Michele Spina, MD    +39 0434/659730    mspina@cro.it   
Principal Investigator: Michele Spina, MD         
Ospedale Degli Infermi - S.C. Oncologia Recruiting
Biella, Italy
Contact: Annarita Conconi, MD       annarita.conconi@aslbi.piemonte.it   
Principal Investigator: Annarita Conconi, MD         
A.O. Spedali Civili di Brescia - Ematologia Recruiting
Brescia, Italy
Contact: Alessandra Tucci       alessandra.tucci@asst-spedalicivili.it   
Principal Investigator: Alessandra Tucci, MD         
Ospedale Businco Recruiting
Cagliari, Italy
Contact: Maria Giuseppina Cabras       cabras.giuseppina@tiscali.it   
Principal Investigator: Maria Giuseppina Cabras, MD         
Ospedale Roberto Binaghi Active, not recruiting
Cagliari, Italy
Ospedale di Castelfranco Veneto - Ematologia Recruiting
Castelfranco Veneto, Italy
Contact: Roberto Sartori, MD       roberto.sartori@aulss2.veneto.it   
Principal Investigator: Roberto Sartori, MD         
HSR Giglio - Oncologia Active, not recruiting
Cefalù, Italy
Osp.Generale Di Zona Valduce Recruiting
Como, Italy, 22100
Contact: Erika Ravelli       erikaravelli@gmail.com   
Principal Investigator: Erika Ravelli, MD         
Ospedale Santa Maria Goretti Latina Active, not recruiting
Latina, Italy, 39100
Ospedale Vito Fazzi - Ematologia Recruiting
Lecce, Italy
Contact: Nicola Di Renzo, MD       direnzo.ematolecce@gmail.com   
Principal Investigator: Nicola Di Renzo, MD         
A.O. Universitaria Policlinico Martino Di Messina Active, not recruiting
Messina, Italy, 98158
Ospedali Riuniti Papardo Recruiting
Messina, Italy, 98158
Contact: Donato Mannina    090-3992250    donamanni@gmail.com   
Principal Investigator: Donato Mannina, MD         
Osp. San Carlo Borromeo Divisione di Oncologia Medica Recruiting
Milano, Italy
Contact: Lucilla Tedeschi       tedeschi.lucilla@sancarlo.mi.it   
Principal Investigator: Lucilla Tedeschi, MD         
A.O. Universitaria Maggiore Della Carita' Di Novara Recruiting
Novara, Italy, 28100
Contact: Gianluca Gaidano       gaidano@med.uniupo.it   
Principal Investigator: Gianluca Gaidano, Prof.         
AOU di Parma - UO Ematologia e CTMO Recruiting
Parma, Italy
Contact: Francesca Re, MD       fre@ao.pr.it   
Principal Investigator: Francesca Re, MD         
A.O. di Perugia - Santa Maria della Misericordia Active, not recruiting
Perugia, Italy, 06132
Ausl Di Piacenza Recruiting
Piacenza, Italy, 29121
Contact: Annalisa Arcari       a.arcari@ausl.pc.it   
Principal Investigator: Annalisa Arcari, MD         
AO Arcispedale S.Maria Nuova Ematologia Recruiting
Reggio Emilia, Italy
Contact: Francesco Merli       merli.francesco@ausl.re.it   
Principal Investigator: Francesco Merli, MD         
Ematologia Ospedale S.Camillo Forlanini Active, not recruiting
Roma, Italy, 00149
Dipartimento di biotecnologie cellulari ed ematologia Ospedale Umberto I - La Sapienza Active, not recruiting
Roma, Italy
Istituto Clinica Humanitas Recruiting
Rozzano (MI), Italy
Contact: Monica Balzarotti       monica.balzarotti@cancercenter.humanitas.it   
Principal Investigator: Monica Balzarotti, MD         
Sponsors and Collaborators
Fondazione Italiana Linfomi ONLUS
Principal Investigator: Maria Giuseppina Cabras Ospedale Businco di Cagliari

Responsible Party: Fondazione Italiana Linfomi ONLUS
ClinicalTrials.gov Identifier: NCT03364439     History of Changes
Other Study ID Numbers: FIL_DLCL10
First Posted: December 6, 2017    Key Record Dates
Last Update Posted: December 6, 2017
Last Verified: December 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Fondazione Italiana Linfomi ONLUS:

Additional relevant MeSH terms:
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin