Clinical trial NCT03364439: R-CHOP14 or R-CHOP21 &Consolidation PET-Oriented Radiotherapy (RT) in DLBCL Patients
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diffuse Large B Cell Lymphoma
Keywords: DLBCL
Lead sponsor: Fondazione Italiana Linfomi - ETS
Sponsor class: OTHER
First posted: 2017-12-06
Enrollment: 109
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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)

Eligibility 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

Primary outcomes:
measure: PFS Progression Free Survival
timeFrame: 24 months
Secondary outcomes:
measure: OS Overall Survival
timeFrame: 48 months
Other outcomes:
Locations:
city: Milano
country: Italy
facility: A.O. Niguarda
state: MI
city: Rionero in Vulture
country: Italy
facility: Centro di Riferimento Oncologico della Basilicata
state: PZ
city: Alessandria
country: Italy
facility: A.O. SS. Antonio e Biagio e C. Arrigo
city: Ancona
country: Italy
facility: A.O. Universitaria Ospedali Riuniti - Ospedale Umberto I Di Ancona
city: Aviano
country: Italy
facility: Centro di riferimento Oncologico Oncologia Medica A
city: Biella
country: Italy
facility: Ospedale Degli Infermi - S.C. Oncologia
city: Brescia
country: Italy
facility: A.O. Spedali Civili di Brescia - Ematologia
city: Brindisi
country: Italy
facility: PO Perrino
city: Cagliari
country: Italy
facility: Ospedale Businco
city: Castelfranco Veneto
country: Italy
facility: Ospedale di Castelfranco Veneto - Ematologia
city: Como
country: Italy
facility: Osp.Generale Di Zona Valduce
city: Milano
country: Italy
facility: Osp. San Carlo Borromeo Divisione di Oncologia Medica
city: Novara
country: Italy
facility: A.O. Universitaria Maggiore Della Carita' Di Novara
city: Parma
country: Italy
facility: AOU di Parma UO Ematologia e CTMO
city: Piacenza
country: Italy
facility: Ausl Di Piacenza
city: Reggio Emilia
country: Italy
facility: AO Arcispedale S.Maria Nuova Ematologia
city: Rozzano (MI)
country: Italy
facility: Istituto Clinica Humanitas
city: Torino
country: Italy
facility: A.O.U. Citta della Salute e della Scienza di Torino - SC Ematologia
city: Torino
country: Italy
facility: A.O.U. Citta della Salute e della Scienza di Torino - Ematologia Universitaria
Study officials:
affiliation: Ospedale Businco di Cagliari
name: Maria Giuseppina Cabras
role: PRINCIPAL_INVESTIGATOR
References: