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

Kosin University Gospel Hospital1 site in 1 country37 target enrollmentApril 13, 2017

ConditionsDiffuse Large B Cell Lymphoma

InterventionsPrednisoLONE 50 MG

DrugsPrednisoLONE 50 MG

Overview

Phase: Phase 2
Intervention: PrednisoLONE 50 MG
Conditions: Diffuse Large B Cell Lymphoma
Sponsor: Kosin University Gospel Hospital
Enrollment: 37
Locations: 1
Primary Endpoint: (treatment-related mortality rate; TRM)
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

April 13, 2017

End Date

July 13, 2021

Last Updated

4 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Kosin University Gospel Hospital

Responsible Party

Principal Investigator

Ho Sup Lee

MD, PhD. associate professor, Division of hematology-Oncology

Kosin University Gospel Hospital

Eligibility Criteria

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

Arms & Interventions

Prednisolone

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

Intervention: PrednisoLONE 50 MG

Outcomes

Primary Outcomes

(treatment-related mortality rate; TRM)

Time Frame: an average of 1 year

treatment-related mortality rate

Secondary Outcomes

IMWG fragility score before and after pre-phase treatment(an average of 1 year)
TRM and RR according to IMWG fragility score(an average of 1 year)
response rate; RR(an average of 1 year)
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0(an average of 1 year)
Incidence of neutropenic fever(an average of 1 year)