R-CHOP14 or R-CHOP21 &Consolidation PET-Oriented Radiotherapy (RT) in DLBCL Patients
- Conditions
- Diffuse Large B Cell Lymphoma
- Interventions
- Drug: Treatment plan
- Registration Number
- NCT03364439
- Lead Sponsor
- Fondazione Italiana Linfomi - ETS
- 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)
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 109
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description One arm for all patients Treatment plan Patients eligible for the study will receive 6 courses of R-CHOP14 or R-CHOP21.
- Primary Outcome Measures
Name Time Method PFS Progression Free Survival 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
Name Time Method OS Overall Survival 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
Trial Locations
- Locations (19)
Ospedale di Castelfranco Veneto - Ematologia
🇮🇹Castelfranco Veneto, Italy
A.O. SS. Antonio e Biagio e C. Arrigo
🇮🇹Alessandria, Italy
Ospedale Businco
🇮🇹Cagliari, Italy
A.O. Niguarda
🇮🇹Milano, MI, Italy
Centro di Riferimento Oncologico della Basilicata
🇮🇹Rionero in Vulture, PZ, Italy
A.O. Universitaria Ospedali Riuniti - Ospedale Umberto I Di Ancona
🇮🇹Ancona, Italy
Ospedale Degli Infermi - S.C. Oncologia
🇮🇹Biella, Italy
Osp.Generale Di Zona Valduce
🇮🇹Como, Italy
Istituto Clinica Humanitas
🇮🇹Rozzano (MI), Italy
A.O.U. Citta della Salute e della Scienza di Torino - Ematologia Universitaria
🇮🇹Torino, Italy
Centro di riferimento Oncologico Oncologia Medica A
🇮🇹Aviano, Italy
A.O. Spedali Civili di Brescia - Ematologia
🇮🇹Brescia, Italy
PO Perrino
🇮🇹Brindisi, Italy
Ausl Di Piacenza
🇮🇹Piacenza, Italy
AO Arcispedale S.Maria Nuova Ematologia
🇮🇹Reggio Emilia, Italy
AOU di Parma UO Ematologia e CTMO
🇮🇹Parma, Italy
Osp. San Carlo Borromeo Divisione di Oncologia Medica
🇮🇹Milano, Italy
A.O. Universitaria Maggiore Della Carita' Di Novara
🇮🇹Novara, Italy
A.O.U. Citta della Salute e della Scienza di Torino - SC Ematologia
🇮🇹Torino, Italy