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

NCT ID: NCT03465527

Last Updated: 2022-04-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

37 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-13

Study Completion Date

2021-07-13

Brief Summary

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

Detailed Description

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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.

Conditions

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Diffuse Large B Cell Lymphoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

PrednisoLONE 50 MG

Intervention Type DRUG

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

Interventions

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PrednisoLONE 50 MG

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kosin University Gospel Hospital

OTHER

Sponsor Role lead

Responsible Party

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Ho Sup Lee

MD, PhD. associate professor, Division of hematology-Oncology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Kosin University Gospel Hospital

Busan, Sue-gu, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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Prephase

Identifier Type: -

Identifier Source: org_study_id

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