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

Sponsor

Fondazione Italiana Linfomi ONLUS (Other)

Overall Status

Completed

CT.gov ID

NCT01148446

Collaborator

(none)

226

Enrollment

Locations

Arms

20.5

Patients Per Site

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Elderly Patients (>65 Years) Diffuse Large B Cell Lymphoma (DLBCL)	Drug: Cyclophosphamide Drug: Cyclophosphamide Drug: Doxorubicin Drug: Vincristine Drug: Prednisone Drug: Prednisone Drug: Epirubicin Drug: Vinblastine Drug: Rituximab Drug: G-CSF	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

226 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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)

Study Start Date :

Jan 1, 2003

Actual Primary Completion Date :

Jan 1, 2006

Arms and Interventions

Arm	Intervention/Treatment
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	Drug: Cyclophosphamide 750 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: Rituximab 375 mg/mq IV, day 1 Drug: G-CSF 300 µg tot., 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	Drug: Cyclophosphamide 50 mg/mq IV, day 1 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

Arm

Intervention/Treatment

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

Drug: Cyclophosphamide

750 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: Rituximab

375 mg/mq IV, day 1

Drug: G-CSF

300 µg tot., 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

Drug: Cyclophosphamide

50 mg/mq IV, day 1

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

Outcome Measures

Primary Outcome Measures

Event Free Survival (EFS) [2 years]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

66 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ospedale di Vigevano	Vigevano	Pavia	Italy
2	S.C. di Ematologia, Spedali Civili	Brescia		Italy	25123
3	Ospedale Garibaldi-Nesima	Catania		Italy
4	Ospedale civile Divisione di Ematologia	Civitanova Marche (MC)		Italy
5	Ospedale San Sebastiano	Correggio (RE)		Italy
6	Presidio Ospedaliero Annunziata	Cosenza		Italy
7	Istituto Vito Fazzi	Lecce		Italy
8	Azienda Ospedaliera Policlinico	Modena		Italy
9	AO Arcispedale S.Maria Nuova Ematologia	Reggio Emilia		Italy
10	Ospedale civile DH oncologico	Sassuolo (MO)		Italy
11	Ospedale San Giovanni Battista - Molinette	Torino		Italy

Sponsors and Collaborators

Fondazione Italiana Linfomi ONLUS

Investigators

Study Chair: Francesco Merli, MD, U.O.A. di Ematologia Azienda Ospedale S. Maria Nuova
Study Chair: Marilena Bertini, MD, U.O.A. di Ematologia Ospedale Molinette