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). |
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Condition | Elderly Patients (>65 Years) Diffuse Large B Cell Lymphoma (DLBCL) |
Intervention | Drug: Cyclophosphamide Drug: Cyclophosphamide Drug: Doxorubicin Drug: Vincristine Drug: Prednisone Drug: Prednisone Drug: Epirubicin Drug: Vinblastine Drug: Rituximab Drug: G-CSF |
Phase | Phase 3 |
Sponsor | Fondazione Italiana Linfomi ONLUS |
Responsible Party | Fondazione Italiana Linfomi ONLUS |
ClinicalTrials.gov Identifier | NCT01148446 |
First Received | June 21, 2010 |
Last Updated | June 21, 2010 |
Last verified | June 2010 |
Tracking Information[ + expand ][ + ]
First Received Date | June 21, 2010 |
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Last Updated Date | June 21, 2010 |
Start Date | January 2003 |
Estimated Primary Completion Date | Not Provided |
Current Primary Outcome Measures | Event Free Survival (EFS) [Time Frame: 2 years] [Designated as safety issue: No] |
Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
Brief Title | R-CHOP Versus R-mini-CEOP in Elderly Patients(>65)With DLBCL |
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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) |
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 Provided |
Study Type | Interventional |
Study Phase | Phase 3 |
Study Design | Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment |
Condition |
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Intervention | Drug: 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) |
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Recruitment Information[ + expand ][ + ]
Recruitment Status | Completed |
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Estimated Enrollment | 226 |
Estimated Completion Date | Not Provided |
Estimated Primary Completion Date | January 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 |
Gender | Both |
Ages | 66 Years |
Accepts Healthy Volunteers | No |
Contacts | Not Provided |
Location Countries | Italy |
Administrative Information[ + expand ][ + ]
NCT Number | NCT01148446 |
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Other Study ID Numbers | IIL ANZINTER3 |
Has Data Monitoring Committee | No |
Information Provided By | Fondazione Italiana Linfomi ONLUS |
Study Sponsor | Fondazione Italiana Linfomi ONLUS |
Collaborators | Not 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 Date | June 2010 |
Locations[ + expand ][ + ]
Ospedale di Vigevano | Vigevano, Pavia, Italy |
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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 |