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

NCT03465527 | Completed Phase 2

• 1 other identifier: Prephase
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Diffuse Large B Cell Lymphoma

Outcome Measures

Primary Outcomes (1)

• (treatment-related mortality rate; TRM)

  treatment-related mortality rate

  an average of 1 year

Secondary Outcomes (5)

• IMWG fragility score before and after pre-phase treatment

  an average of 1 year

• TRM and RR according to IMWG fragility score

  an average of 1 year

• response rate; RR

  an average of 1 year

• Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

  an average of 1 year

• Incidence of neutropenic fever

  an average of 1 year

Study Arms (1)

Prednisolone

EXPERIMENTAL

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

Interventions

PrednisoLONE 50 MG DRUG

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

Prednisolone

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kosin University Gospel Hospital: lead

Study Sites (1)

Kosin University Gospel Hospital

Busan, Sue-gu, 60542, South Korea

Location

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse

Interventions

Prednisolone

Condition Hierarchy (Ancestors)

Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD. associate professor, Division of hematology-Oncology

Study Record Dates

• First Submitted: January 8, 2018
• First Posted: March 14, 2018
• Study Start: April 13, 2017
• Primary Completion: July 13, 2021
• Study Completion: July 13, 2021
• Last Updated: April 1, 2022

Record last verified: 2022-03

Locations

KR (1)