ANZINTER3: R-CHOP Versus R-mini-CEOP in Elderly Patients(>65)With DLBCL
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 |
---|---|---|
Phase 3 |
Study Design
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
|
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
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
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IIL ANZINTER3