A Randomized Phase III Randomized Study to Compare R-CHOP Versus R-mini-CEOP in Elderly Patients (>65 Years) With Diffuse Large B Cell Lymphoma (DLBCL)
Phase 3
66 Years
80 Years
66 Years
80 Years
Not Enrolling
Both
Elderly Patients (>65 Years), Diffuse Large B Cell Lymphoma (DLBCL)
Both
Elderly Patients (>65 Years), Diffuse Large B Cell Lymphoma (DLBCL)
Trial Information
A Randomized Phase III Randomized Study to Compare R-CHOP Versus R-mini-CEOP in Elderly Patients (>65 Years) With Diffuse Large B Cell Lymphoma (DLBCL)
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Event Free Survival (EFS)
Outcome Time Frame:
2 years
Safety Issue:
No
Principal Investigator
Francesco Merli, MD
Investigator Role:
Study Chair
Investigator Affiliation:
U.O.A. di Ematologia Azienda Ospedale S. Maria Nuova
Authority:
Italy: The Italian Medicines Agency
Study ID:
IIL ANZINTER3
NCT ID:
NCT01148446
Start Date:
January 2003
Completion Date:
Related Keywords:
- Elderly Patients (>65 Years)
- Diffuse Large B Cell Lymphoma (DLBCL)
- DLBCL
- R-CHOP
- R-CEOP
- Elderly patients
- Lymphoma
- Lymphoma, B-Cell
- Lymphoma, Large B-Cell, Diffuse
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