Diffuse Large B Cell Lymphoma
Conditions
Brief summary
A phase 2 trial of pre-phase treatment before R-CHOP chemotherapy in elderly patients with newly diagnosed DLBCL
Detailed description
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.
Interventions
DRUGPrednisoLONE 50 MG
Prednisolone 50mg bid po or iv (equivalent dose of other steroid) for 5 days ± 2 days
Sponsors
Kosin University Gospel Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Histologically the first large-scaled B-cell lymphoma patient 2. Diagnosis time 65 years old or older 3. Patients planning R-CHOP chemotherapy 4. Ann Arbor stage 2 (bulky ≥ diameter of 7cm), stage 3 or stage 4 5. The International Prognostic Index (IPI) is a high intermediate or high risk 6. Patients without prior history of lymphoma 7. The decision to participate voluntarily in this study and the written consent of the patient
Exclusion criteria
1. Histologic subtypes other than CD20 positive broad-band macro-B cell lymphoma 2. Large B-cell lymphoma involving the central nervous system 3. 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 4. If the drug used in this study is allergic 5. If you do not agree to participate in the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| (treatment-related mortality rate; TRM) | an average of 1 year | treatment-related mortality rate |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| IMWG fragility score before and after pre-phase treatment | an average of 1 year | International Myeloma Working Group,( IMWG) |
| TRM and RR according to IMWG fragility score | an average of 1 year | International Myeloma Working Group,( IMWG) |
| response rate; RR | an average of 1 year | response rate |
| Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 | an average of 1 year | safety |
| Incidence of neutropenic fever | an average of 1 year | Incidence of neutropenic fever |
Countries
South Korea
Outcome results
None listed