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

Overview[ - collapse ][ - ]

Purpose 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).
ConditionElderly Patients (>65 Years)
Diffuse Large B Cell Lymphoma (DLBCL)
InterventionDrug: Cyclophosphamide
Drug: Cyclophosphamide
Drug: Doxorubicin
Drug: Vincristine
Drug: Prednisone
Drug: Prednisone
Drug: Epirubicin
Drug: Vinblastine
Drug: Rituximab
Drug: G-CSF
PhasePhase 3
SponsorFondazione Italiana Linfomi ONLUS
Responsible PartyFondazione Italiana Linfomi ONLUS
ClinicalTrials.gov IdentifierNCT01148446
First ReceivedJune 21, 2010
Last UpdatedJune 21, 2010
Last verifiedJune 2010

Tracking Information[ + expand ][ + ]

First Received DateJune 21, 2010
Last Updated DateJune 21, 2010
Start DateJanuary 2003
Estimated Primary Completion DateNot Provided
Current Primary Outcome MeasuresEvent Free Survival (EFS) [Time Frame: 2 years] [Designated as safety issue: No]
Current Secondary Outcome Measures
  • Complete Remission (CR) rate [Time Frame: 2 years] [Designated as safety issue: No]
  • Disease Free Survival (DFS) [Time Frame: 2 years] [Designated as safety issue: No]
  • Multidimensional Evaluation Scale for the definition of "frail" and "non frail" patients [Time Frame: 2 years] [Designated as safety issue: Yes]

Descriptive Information[ + expand ][ + ]

Brief TitleR-CHOP Versus R-mini-CEOP in Elderly Patients(>65)With DLBCL
Official TitleA 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)
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 DescriptionNot Provided
Study TypeInterventional
Study PhasePhase 3
Study DesignAllocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Condition
  • Elderly Patients (>65 Years)
  • Diffuse Large B Cell Lymphoma (DLBCL)
InterventionDrug: Cyclophosphamide
750 mg/mq IV, day 1
Drug: Cyclophosphamide
50 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: 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
Study Arm (s)
  • 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
  • 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

Recruitment Information[ + expand ][ + ]

Recruitment StatusCompleted
Estimated Enrollment226
Estimated Completion DateNot Provided
Estimated Primary Completion DateJanuary 2006
Eligibility Criteria
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
GenderBoth
Ages66 Years
Accepts Healthy VolunteersNo
ContactsNot Provided
Location CountriesItaly

Administrative Information[ + expand ][ + ]

NCT Number NCT01148446
Other Study ID NumbersIIL ANZINTER3
Has Data Monitoring CommitteeNo
Information Provided ByFondazione Italiana Linfomi ONLUS
Study SponsorFondazione Italiana Linfomi ONLUS
CollaboratorsNot Provided
Investigators Study Chair: Francesco Merli, MD U.O.A. di Ematologia Azienda Ospedale S. Maria NuovaStudy Chair: Marilena Bertini, MD U.O.A. di Ematologia Ospedale Molinette
Verification DateJune 2010

Locations[ + expand ][ + ]

Ospedale di Vigevano
Vigevano, Pavia, Italy
S.C. di Ematologia, Spedali Civili
Brescia, Italy, 25123
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