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

Kosin University Gospel Hospital

Status and phase: Completed; Phase 2

Conditions: Diffuse Large B Cell Lymphoma

Treatments: Drug: PrednisoLONE 50 MG

Study type: Interventional

Funder types: Other

Identifiers

NCT03465527

Prephase

Details and patient eligibility

About

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

Full 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.

Enrollment: 37 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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37 participants in 1 patient group

Prednisolone

Experimental group

Description:

Prednisolone 50mg bid po or iv (equivalent dose of other steroid) for 5 days ± 2 days Hydration, antibiotics, allopurinol, nutritional supplements, and so on.

Treatment:

Drug: PrednisoLONE 50 MG