Pre-phase Treatment Before R-CHOP Chemotherapy in Elderly Patients With Newly Diagnosed DLBCL

Study Overview
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Brief Summary
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A phase 2 trial of pre-phase treatment before R-CHOP chemotherapy in elderly patients with newly diagnosed DLBCL

Detailed Description
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R-CHOP Chemotherapy Cataract treatment with anterior steroids Phenotypic effects Evaluate the felony associated with the procedure for the primary purpose. This study evaluated efficacy, treatment outcome and safety for all patients.

Official Title
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A Phase 2 Trial of Pre-phase Treatment Before R-CHOP Chemotherapy in Elderly Patients With Newly Diagnosed DLBCL

Conditions
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Diffuse Large B Cell Lymphoma

Intervention / Treatment
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* Drug: PrednisoLONE 50 MG


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically the first large-scaled B-cell lymphoma patient Diagnosis time 65 years old or older Patients planning R-CHOP chemotherapy Ann Arbor stage 2 (bulky ≥ diameter of 7cm), stage 3 or stage 4 The International Prognostic Index (IPI) is a high intermediate or high risk Patients without prior history of lymphoma The decision to participate voluntarily in this study and the written consent of the patient Exclusion Criteria: Histologic subtypes other than CD20 positive broad-band macro-B cell lymphoma Large B-cell lymphoma involving the central nervous system Inadequate systemic disease A. Patients with clinically significant heart disease (congestive heart failure, symptomatic coronary artery disease, cardiac arrhythmia) or myocardial infarction within the past 6 months B. Serious neurological and psychiatric illness C. Serious active infection D. Other medical illnesses other than clinical trials If the drug used in this study is allergic If you do not agree to participate in the study

Ages Eligible for Study
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Minimum Age: 65 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: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prednisolone<br>Prednisolone 50mg bid po or iv (equivalent dose of other steroid) for 5 days ± 2 days Hydration, antibiotics, allopurinol, nutritional supplements, and so on. | Drug: PrednisoLONE 50 MG<br>* Prednisolone 50mg bid po or iv (equivalent dose of other steroid) for 5 days ± 2 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| (treatment-related mortality rate; TRM) | treatment-related mortality rate | an average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IMWG fragility score before and after pre-phase treatment | International Myeloma Working Group,( IMWG) | an average of 1 year | 
| TRM and RR according to IMWG fragility score | International Myeloma Working Group,( IMWG) | an average of 1 year | 
| response rate; RR | response rate | an average of 1 year | 
| Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 | safety | an average of 1 year | 
| Incidence of neutropenic fever | Incidence of neutropenic fever | an average of 1 year |