R-CHOP Versus R-mini-CEOP in Elderly Patients(>65)With DLBCL

Sponsor
Fondazione Italiana Linfomi - ETS
Study ID
NCT01148446
Phase
PHASE3
Status
Completed

Conditions

  • Diffuse Large B Cell Lymphoma (DLBCL)
  • Elderly Patients (>65 Years)

Eligibility Criteria

Sex
ALL
Age
66 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Cyclophosphamide — DRUG
    750 mg/mq IV, day 1
  • Cyclophosphamide — DRUG
    50 mg/mq IV, day 1
  • Doxorubicin — DRUG
    50 mg/mq IV, day1
  • Vincristine — DRUG
    1,4 mg/mq (max 2 mg)IV, day 1
  • Prednisone — DRUG
    75 mg/mq IV, days 1-5
  • Prednisone — DRUG
    60 mg/mq IV/PO, days 1-5
  • Epirubicin — DRUG
    50 mg/mq IV, day 1
  • Vinblastine — DRUG
    5 mg/mq IV, day 1
  • Rituximab — DRUG
    375 mg/mq IV, day 1
  • G-CSF — DRUG
    300 µg tot., SC; days 7-11

Study Details

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).

Key Dates

Start date
Jan 31, 2003
Status verified
Jun 2010
Primary completion
Jan 31, 2006

Study Design

Enrollment
226 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: R-CHOP
    R-CHOP (every 21 days) for six courses Cyclophosphamide: 750 mg/m2, IV, day 1 Doxorubicin: 50 mg/m2, IV, day 1 Vincristine: 1.4 (max 2) mg/m2, IV, day 1 Prednisone: 75 mg/m2, IV, days 1-5 Rituximab: 375 mg/m2, IV, day 1 G-CSF: 300 µg tota, SC; days 7-11
  • Experimental: R-mini-CEOP
    R-miniCEOP (every 21 days)for six courses Cyclophosphamide: 50 mg/m2, IV, day 1 Epirubicin: 50 mg/m2, IV, day 1 Vinblastine: 5 mg/m2, IV, day 1 Prednisone: 60 mg/m2, IV/PO, days 1-5 Rituximab: 375 mg/m2, IV, day 1 G-CSF: 300 µg tota, SC; days 7-11

Primary Outcome Measure

Event Free Survival (EFS) [ Time Frame: 2 years ]

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