R-CHOP14 or R-CHOP21 &Consolidation PET-Oriented Radiotherapy (RT) in DLBCL Patients (FIL_DLCL10)

Fondazione Italiana Linfomi - ETS

Status and phase: Completed; Phase 2

Conditions: Diffuse Large B Cell Lymphoma

Treatments: Drug: Treatment plan

Study type: Interventional

Funder types: Other

Identifiers

NCT03364439

FIL_DLCL10

Details and patient eligibility

About

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

Full 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)

Enrollment: 109 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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109 participants in 1 patient group

One arm for all patients

Experimental group

Description:

Patients eligible for the study will receive 6 courses of R-CHOP14 or R-CHOP21.

Treatment:

Drug: Treatment plan