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Completed

NCT Number: NCT03465527

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

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Key information

Conditions

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

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Kosin University Gospel Hospital

Busan, Sue-gu, 60542, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PrednisoLONE 50 MG

Drug

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

Primary outcomes

  1. (treatment-related mortality rate; TRM)

    Time frame: an average of 1 year

    treatment-related mortality rate

Secondary outcomes

  1. IMWG fragility score before and after pre-phase treatment

    Time frame: an average of 1 year

    International Myeloma Working Group,( IMWG)

  2. TRM and RR according to IMWG fragility score

    Time frame: an average of 1 year

    International Myeloma Working Group,( IMWG)

  3. response rate; RR

    Time frame: an average of 1 year

    response rate

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

    Time frame: an average of 1 year

    safety

  5. Incidence of neutropenic fever

    Time frame: an average of 1 year

    Incidence of neutropenic fever

Sponsors and collaborators

Lead sponsor

Kosin University Gospel Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Mar 14, 2018
Registry last updated
Apr 1, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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