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

Phase 3

Completed

• Conditions: Elderly Patients (>65 Years); Diffuse Large B Cell Lymphoma (DLBCL)
• Interventions: Drug: Cyclophosphamide; Drug: Doxorubicin; Drug: Epirubicin; Drug: Vincristine; Drug: Prednisone; Drug: Vinblastine; Drug: Rituximab; Drug: G-CSF

• Registration Number: NCT01148446
• Lead Sponsor: Fondazione Italiana Linfomi - ETS

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2003-01
• Primary Completion: 2006-01
• Status Verified: 2010-06
• Study First Submitted: 2010-06-21
• Study First Submitted QC: 2010-06-21
• Last Update Submitted: 2010-06-21
• Study First Posted: 2010-06-22
• Last Update Posted: 2010-06-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 226

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
R-mini-CEOP	Epirubicin	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
R-CHOP	Cyclophosphamide	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-CHOP	Doxorubicin	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-CHOP	Prednisone	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-CHOP	Vincristine	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-CHOP	Rituximab	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-CHOP	G-CSF	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	Cyclophosphamide	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
R-mini-CEOP	Prednisone	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
R-mini-CEOP	Rituximab	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
R-mini-CEOP	Vinblastine	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
R-mini-CEOP	G-CSF	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 Measures

Name	Time	Method
Event Free Survival (EFS)	2 years

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (11)

Ospedale San Sebastiano; 🇮🇹 Correggio (RE), Italy

Istituto Vito Fazzi; 🇮🇹 Lecce, Italy

S.C. di Ematologia, Spedali Civili; 🇮🇹 Brescia, Italy

Ospedale di Vigevano; 🇮🇹 Vigevano, Pavia, Italy

Ospedale Garibaldi-Nesima; 🇮🇹 Catania, Italy

Ospedale civile Divisione di Ematologia; 🇮🇹 Civitanova Marche (MC), Italy

AO Arcispedale S.Maria Nuova Ematologia; 🇮🇹 Reggio Emilia, Italy

Azienda Ospedaliera Policlinico; 🇮🇹 Modena, Italy

Ospedale civile DH oncologico; 🇮🇹 Sassuolo (MO), Italy

Ospedale San Giovanni Battista - Molinette; 🇮🇹 Torino, Italy

Presidio Ospedaliero Annunziata; 🇮🇹 Cosenza, Italy