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

Diffuse Large B Cell Lymphoma (DLBCL) Clinical Trial

— ANZINTER3  

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01148446
• Other study ID #: IIL ANZINTER3
• Status: Completed
• Phase: Phase 3
• First received: June 21, 2010
• Last updated: June 21, 2010
• Start date: January 2003

Study information

• Verified date: June 2010
• Source: Fondazione Italiana Linfomi ONLUS
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: The Italian Medicines Agency
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 226
• Est. primary completion date: January 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 66 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
Italy	S.C. di Ematologia, Spedali Civili	Brescia
Italy	Ospedale Garibaldi-Nesima	Catania
Italy	Ospedale civile Divisione di Ematologia	Civitanova Marche (MC)
Italy	Ospedale San Sebastiano	Correggio (RE)
Italy	Presidio Ospedaliero Annunziata	Cosenza
Italy	Istituto Vito Fazzi	Lecce
Italy	Azienda Ospedaliera Policlinico	Modena
Italy	AO Arcispedale S.Maria Nuova Ematologia	Reggio Emilia
Italy	Ospedale civile DH oncologico	Sassuolo (MO)
Italy	Ospedale San Giovanni Battista - Molinette	Torino
Italy	Ospedale di Vigevano	Vigevano	Pavia

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Italiana Linfomi ONLUS

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Event Free Survival (EFS)		2 years	No
Secondary	Complete Remission (CR) rate		2 years	No
Secondary	Disease Free Survival (DFS)		2 years	No
Secondary	Multidimensional Evaluation Scale for the definition of "frail" and "non frail" patients		2 years	Yes