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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT01148446 |
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Date of registration:
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21/06/2010 |
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Primary sponsor: |
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Public title:
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R-CHOP Versus R-mini-CEOP in Elderly Patients(>65)With DLBCL
ANZINTER3 |
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Scientific title:
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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) |
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Date of first enrolment:
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January 2003 |
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Target sample size:
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226 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01148446 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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Italy
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Contacts
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Name:
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Francesco Merli, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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U.O.A. di Ematologia Azienda Ospedale S. Maria Nuova |
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Name:
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Marilena Bertini, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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U.O.A. di Ematologia Ospedale Molinette |
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Key inclusion & exclusion criteria
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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
Age minimum:
66 Years
Age maximum:
80 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Diffuse Large B Cell Lymphoma (DLBCL)
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Elderly Patients (>65 Years)
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Intervention(s)
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Drug: Cyclophosphamide
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Drug: Doxorubicin
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Drug: Epirubicin
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Drug: G-CSF
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Drug: Prednisone
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Drug: Rituximab
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Drug: Vinblastine
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Drug: Vincristine
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Primary Outcome(s)
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Event Free Survival (EFS)
[Time Frame: 2 years]
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Secondary Outcome(s)
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Complete Remission (CR) rate
[Time Frame: 2 years]
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Disease Free Survival (DFS)
[Time Frame: 2 years]
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Multidimensional Evaluation Scale for the definition of "frail" and "non frail" patients
[Time Frame: 2 years]
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Secondary ID(s)
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IIL ANZINTER3
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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