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

Sponsor

Kosin University Gospel Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT03465527

Collaborator

(none)

Enrollment

Location

Arm

Actual Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Diffuse Large B Cell Lymphoma	Drug: PrednisoLONE 50 MG	Phase 2

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 Design

Study Type:

Interventional

Actual Enrollment :

37 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Apr 13, 2017

Actual Primary Completion Date :

Jul 13, 2021

Actual Study Completion Date :

Jul 13, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Drug: PrednisoLONE 50 MG Prednisolone 50mg bid po or iv (equivalent dose of other steroid) for 5 days ± 2 days

Arm

Intervention/Treatment

Experimental: 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.

Drug: PrednisoLONE 50 MG

Prednisolone 50mg bid po or iv (equivalent dose of other steroid) for 5 days ± 2 days

Outcome Measures

Primary Outcome Measures

(treatment-related mortality rate; TRM) [an average of 1 year]
treatment-related mortality rate

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kosin University Gospel Hospital	Busan	Sue-gu	Korea, Republic of	60542

Sponsors and Collaborators

Kosin University Gospel Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ho Sup Lee, MD, PhD. associate professor, Division of hematology-Oncology, Kosin University Gospel Hospital

ClinicalTrials.gov Identifier:

NCT03465527

Other Study ID Numbers:

Prephase

First Posted:

Mar 14, 2018

Last Update Posted:

Apr 1, 2022

Last Verified:

Mar 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Lymphoma, Large B-Cell, Diffuse

Prednisolone

Study Results

No Results Posted as of Apr 1, 2022