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

• Status: Completed
• Trial end date: 2021-04-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fondazione Italiana Linfomi ONLUS

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