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

Study Overview
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Brief Summary
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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).

Official 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)

Conditions
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Elderly Patients (>65 Years), Diffuse Large B Cell Lymphoma (DLBCL)

Intervention / Treatment
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* Drug: Cyclophosphamide
* Drug: Cyclophosphamide
* Drug: Doxorubicin
* Drug: Vincristine
* Drug: Prednisone
* Drug: Prednisone
* Drug: Epirubicin
* Drug: Vinblastine
* Drug: Rituximab
* Drug: G-CSF


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 66 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: R-CHOP<br>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<br>* 750 mg/mq IV, day 1<br>Drug: Doxorubicin<br>* 50 mg/mq IV, day1<br>Drug: Vincristine<br>* 1,4 mg/mq (max 2 mg)IV, day 1<br>Drug: Prednisone<br>* 75 mg/mq IV, days 1-5<br>Drug: Rituximab<br>* 375 mg/mq IV, day 1<br>Drug: G-CSF<br>* 300 µg tot., SC; days 7-11<br>|
| Experimental: R-mini-CEOP<br>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<br>* 50 mg/mq IV, day 1<br>Drug: Prednisone<br>* 60 mg/mq IV/PO, days 1-5<br>Drug: Epirubicin<br>* 50 mg/mq IV, day 1<br>Drug: Vinblastine<br>* 5 mg/mq IV, day 1<br>Drug: Rituximab<br>* 375 mg/mq IV, day 1<br>Drug: G-CSF<br>* 300 µg tot., SC; days 7-11<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Event Free Survival (EFS) |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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DLBCL, R-CHOP, R-CEOP, Elderly patients