- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03465527
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
Conditions
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:
- 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
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.
Sponsor
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
Additional Relevant MeSH Terms
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Lymphoma, Non-Hodgkin
- Lymphoma
- Lymphoma, B-Cell
- Lymphoma, Large B-Cell, Diffuse
- Physiological Effects of Drugs
- Anti-Inflammatory Agents
- Antineoplastic Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Prednisolone
Other Study ID Numbers
- Prephase
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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