Status:
COMPLETED
R-CHOP Versus R-mini-CEOP in Elderly Patients(>65)With DLBCL
Lead Sponsor:
Fondazione Italiana Linfomi - ETS
Conditions:
Elderly Patients (>65 Years)
Diffuse Large B Cell Lymphoma (DLBCL)
Eligibility:
All Genders
66-80 years
Phase:
PHASE3
Brief Summary
The study has the purpose to compare R-CHOP versus R-mini-CEOP in elderly patients (\>65 years) with Diffuse Large B Cell Lymphoma (DLBCL).
Eligibility Criteria
Inclusion
- Patients with untreated DLBCL aged 66 to 80 years without major accompanying diseases and considered as "non frail".
- Patients were classified as "non frail" (fit) if they had
- ADL (Activity of Daily Living) score of 6
- less than three grade 3 Cumulative Illness Rating Score for Geriatrics (CIRS-G) co-morbidities and no grade 4 co-morbidities
- absence of geriatric syndrome
- Patients HIV negativity;
- Concurrent malignancy;
- Written Informed Consent.
Exclusion
- All other patients were classified as "unfit", and were excluded from randomization
Key Trial Info
Start Date :
January 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
226 Patients enrolled
Trial Details
Trial ID
NCT01148446
Start Date
January 1 2003
Last Update
June 22 2010
Active Locations (11)
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1
S.C. di Ematologia, Spedali Civili
Brescia, Brescia, Italy, 25123
2
Ospedale di Vigevano
Vigevano, Pavia, Italy
3
Ospedale Garibaldi-Nesima
Catania, Italy
4
Ospedale civile Divisione di Ematologia
Civitanova Marche (MC), Italy