R-CHOP Versus R-mini-CEOP in Elderly Patients(>65)With DLBCL (ANZINTER3)

Fondazione Italiana Linfomi - ETS

Status and phase: Completed; Phase 3

Conditions: Elderly Patients (>65 Years); Diffuse Large B Cell Lymphoma (DLBCL)

Treatments: Drug: Vinblastine; Drug: G-CSF; Drug: Vincristine; Drug: Epirubicin; Drug: Rituximab; Drug: Prednisone; Drug: Doxorubicin; Drug: Cyclophosphamide

Study type: Interventional

Funder types: Other

Identifiers

NCT01148446

IIL ANZINTER3

Details and patient eligibility

About

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).

Enrollment: 226 patients

Sex: All

Ages: 66 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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226 participants in 2 patient groups

R-CHOP

Experimental group

Description:

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

Treatment:

Drug: Cyclophosphamide

Drug: Prednisone

Drug: Cyclophosphamide

Drug: Rituximab

Drug: Prednisone

Drug: Doxorubicin

Drug: G-CSF

Drug: Vincristine

R-mini-CEOP

Experimental group

Description:

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

Treatment:

Drug: Cyclophosphamide

Drug: Prednisone

Drug: Epirubicin

Drug: Cyclophosphamide

Drug: Rituximab

Drug: Prednisone

Drug: G-CSF

Drug: Vinblastine