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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 : Active, not recruiting
First Posted : December 6, 2017
Last Update Posted : November 26, 2018
Sponsor:
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)
Actual 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
Actual Primary Completion Date : April 2018
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

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, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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


Locations
Italy
A.O. Niguarda
Milano, MI, Italy, 20162
Centro di Riferimento Oncologico della Basilicata
Rionero in Vulture, PZ, Italy, 85028
A.O. SS. Antonio e Biagio e C. Arrigo
Alessandria, Italy, 15121
A.O. Universitaria Ospedali Riuniti - Ospedale Umberto I Di Ancona
Ancona, Italy, 60126
Centro di riferimento Oncologico Oncologia Medica A
Aviano, Italy
Ospedale Degli Infermi - S.C. Oncologia
Biella, Italy
A.O. Spedali Civili di Brescia - Ematologia
Brescia, Italy
PO Perrino
Brindisi, Italy, 72100
Ospedale Businco
Cagliari, Italy
Ospedale di Castelfranco Veneto - Ematologia
Castelfranco Veneto, Italy
Osp.Generale Di Zona Valduce
Como, Italy, 22100
Ospedale Vito Fazzi - Ematologia
Lecce, Italy
Ospedali Riuniti Papardo
Messina, Italy, 98158
Osp. San Carlo Borromeo Divisione di Oncologia Medica
Milano, Italy
A.O. Universitaria Maggiore Della Carita' Di Novara
Novara, Italy, 28100
AOU di Parma - UO Ematologia e CTMO
Parma, Italy
Ausl Di Piacenza
Piacenza, Italy, 29121
AO Arcispedale S.Maria Nuova Ematologia
Reggio Emilia, Italy
Istituto Clinica Humanitas
Rozzano (MI), Italy
A.O.U. Citta della Salute e della Scienza di Torino - SC Ematologia
Torino, Italy, 10126
A.O.U. Citta della Salute e della Scienza di Torino - Ematologia Universitaria
Torino, Italy
Sponsors and Collaborators
Fondazione Italiana Linfomi ONLUS
Investigators
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: November 26, 2018
Last Verified: November 2018

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:
DLBCL

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