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

March 31, 2022 updated by: Ho Sup Lee, Kosin University Gospel Hospital

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

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

Study Overview

Status

Completed

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

37

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Sue-gu
      • Busan, Sue-gu, Korea, Republic of, 60542
        • Kosin University Gospel Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
(treatment-related mortality rate; TRM)
Time Frame: an average of 1 year
treatment-related mortality rate
an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
IMWG fragility score before and after pre-phase treatment
Time Frame: an average of 1 year
International Myeloma Working Group,( IMWG)
an average of 1 year
TRM and RR according to IMWG fragility score
Time Frame: an average of 1 year
International Myeloma Working Group,( IMWG)
an average of 1 year
response rate; RR
Time Frame: an average of 1 year
response rate
an average of 1 year
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time Frame: an average of 1 year
safety
an average of 1 year
Incidence of neutropenic fever
Time Frame: an average of 1 year
Incidence of neutropenic fever
an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 13, 2017

Primary Completion (Actual)

July 13, 2021

Study Completion (Actual)

July 13, 2021

Study Registration Dates

First Submitted

January 8, 2018

First Submitted That Met QC Criteria

March 13, 2018

First Posted (Actual)

March 14, 2018

Study Record Updates

Last Update Posted (Actual)

April 1, 2022

Last Update Submitted That Met QC Criteria

March 31, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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