Diffuse Large B Cell Lymphoma
Conditions
Keywords
DLBCL
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)
Interventions
DRUGTreatment 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)
Sponsors
Fondazione Italiana Linfomi - ETS
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Italy
Outcome results
None listed