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

Primary Purpose

Diffuse Large B Cell Lymphoma

Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
PrednisoLONE 50 MG
Sponsored by
Kosin University Gospel Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Diffuse Large B Cell Lymphoma

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Kosin University Gospel Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Prednisolone

Arm 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.

Outcomes

Primary Outcome Measures

(treatment-related mortality rate; TRM)
treatment-related mortality rate

Secondary Outcome Measures

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

Full Information

First Posted
January 8, 2018
Last Updated
March 31, 2022
Sponsor
Kosin University Gospel Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03465527
Brief Title
Pre-phase Treatment Before R-CHOP Chemotherapy in Elderly Patients With Newly Diagnosed DLBCL
Official Title
A Phase 2 Trial of Pre-phase Treatment Before R-CHOP Chemotherapy in Elderly Patients With Newly Diagnosed DLBCL
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
April 13, 2017 (Actual)
Primary Completion Date
July 13, 2021 (Actual)
Study Completion Date
July 13, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kosin University Gospel Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diffuse Large B Cell Lymphoma

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
37 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Prednisolone
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
PrednisoLONE 50 MG
Intervention Description
Prednisolone 50mg bid po or iv (equivalent dose of other steroid) for 5 days ± 2 days
Primary Outcome Measure Information:
Title
(treatment-related mortality rate; TRM)
Description
treatment-related mortality rate
Time Frame
an average of 1 year
Secondary Outcome Measure Information:
Title
IMWG fragility score before and after pre-phase treatment
Description
International Myeloma Working Group,( IMWG)
Time Frame
an average of 1 year
Title
TRM and RR according to IMWG fragility score
Description
International Myeloma Working Group,( IMWG)
Time Frame
an average of 1 year
Title
response rate; RR
Description
response rate
Time Frame
an average of 1 year
Title
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Description
safety
Time Frame
an average of 1 year
Title
Incidence of neutropenic fever
Description
Incidence of neutropenic fever
Time Frame
an average of 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Kosin University Gospel Hospital
City
Busan
State/Province
Sue-gu
ZIP/Postal Code
60542
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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