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

Phase 2

Completed

• Conditions: Diffuse Large B Cell Lymphoma
• Interventions: Drug: PrednisoLONE 50 MG

• Registration Number: NCT03465527
• Lead Sponsor: Kosin University Gospel Hospital

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.

Study Timeline

• Study Start: 2017-04-13
• Study First Submitted: 2018-01-08
• Study First Submitted QC: 2018-03-13
• Study First Posted: 2018-03-14
• Primary Completion: 2021-07-13
• Study Completion: 2021-07-13
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-31
• Last Update Posted: 2022-04-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 37

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
(treatment-related mortality rate; TRM)	an average of 1 year	treatment-related mortality rate

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Kosin University Gospel Hospital; 🇰🇷 Busan, Sue-gu, Korea, Republic of