Trial | NCT01148446  Report issue

Title

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

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    226
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).
Study Started
Jan 31
2003
Primary Completion
Jan 31
2006
Last Update
Jun 22
2010
Estimate

Drug Cyclophosphamide

750 mg/mq IV, day 1

Drug Cyclophosphamide

50 mg/mq IV, day 1

Drug Doxorubicin

50 mg/mq IV, day1

Drug Vincristine

1,4 mg/mq (max 2 mg)IV, day 1

Drug Prednisone

75 mg/mq IV, days 1-5

Drug Prednisone

60 mg/mq IV/PO, days 1-5

Drug Epirubicin

50 mg/mq IV, day 1

Drug Vinblastine

5 mg/mq IV, day 1

Drug Rituximab

375 mg/mq IV, day 1

Drug G-CSF

300 µg tot., SC; days 7-11

R-CHOP Experimental

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

R-mini-CEOP Experimental

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

Criteria 

Inclusion Criteria:

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 Criteria:

All other patients were classified as "unfit", and were excluded from randomization
No Results Posted