Diffuse Large B Cell Lymphoma (DLBCL), Elderly Patients (>65 Years)
Conditions
Keywords
DLBCL, R-CHOP, R-CEOP, Elderly patients
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).
Interventions
DRUGCyclophosphamide
750 mg/mq IV, day 1
DRUGDoxorubicin
50 mg/mq IV, day1
DRUGVincristine
1,4 mg/mq (max 2 mg)IV, day 1
DRUGPrednisone
75 mg/mq IV, days 1-5
DRUGEpirubicin
50 mg/mq IV, day 1
DRUGVinblastine
5 mg/mq IV, day 1
DRUGRituximab
375 mg/mq IV, day 1
DRUGG-CSF
300 µg tot., SC; days 7-11
Sponsors
Fondazione Italiana Linfomi - ETS
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
66 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Patients with untreated DLBCL aged 66 to 80 years without major accompanying diseases and considered as non frail. 2. 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 3. Patients HIV negativity; 4. Concurrent malignancy; 5. Written Informed Consent.
Exclusion criteria
* All other patients were classified as unfit, and were excluded from randomization
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Event Free Survival (EFS) | 2 years |
Secondary
| Measure | Time frame |
|---|---|
| Complete Remission (CR) rate | 2 years |
| Disease Free Survival (DFS) | 2 years |
| Multidimensional Evaluation Scale for the definition of frail and non frail patients | 2 years |
Countries
Italy
Outcome results
None listed