Status:
COMPLETED
R-CHOP14 or R-CHOP21 &Consolidation PET-Oriented Radiotherapy (RT) in DLBCL Patients
Lead Sponsor:
Fondazione Italiana Linfomi - ETS
Conditions:
Diffuse Large B Cell Lymphoma
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
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 t...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 18 2021
Estimated Enrollment :
109 Patients enrolled
Trial Details
Trial ID
NCT03364439
Start Date
January 1 2012
End Date
March 18 2021
Last Update
March 3 2022
Active Locations (19)
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1
A.O. Niguarda
Milan, MI, Italy, 20162
2
Centro di Riferimento Oncologico della Basilicata
Rionero in Vulture, PZ, Italy, 85028
3
A.O. SS. Antonio e Biagio e C. Arrigo
Alessandria, Italy, 15121
4
A.O. Universitaria Ospedali Riuniti - Ospedale Umberto I Di Ancona
Ancona, Italy, 60126