Dose Dense Chemotherapy in Elderly Patients > 80 Years Old With DLBCL

November 20, 2023 updated by: Konstantinos Christofyllakis, University Hospital, Saarland
Multi-center retrospective analysis of patients with DLBCL aged ≥80 years old treated with R-CHOP-14 compared to other regimens. Patient data including baseline characteristics, histology, dose intensity and treatment outcomes will be extracted from hospital medical electronic records. Relative dose intensity (RDI) will be calculated as the percentage of the dose intensity achieved divided by the intended dose intensity. Primary endpoints are overall (OS), progression-free (PFS) and event-free survival (EFS), defined as time from diagnosis to death, death or progression/relapse, progression/relapse or treatment discontinuation.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

79

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

  • Germany
    • Saarland
      • Homburg, Saarland, Germany, 66424
        • Saarland University Medical Center

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

  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Elderly patients with DLBCL

Description

Inclusion Criteria:

  • histologically proven, untreated diffus large B-cell lymphoma (DLBCL)
  • diagnosis between 2005 - 2019
  • age ≥80 at diagnosis

Exclusion Criteria:

- diagnosis revision at a later timepoint

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

Cohorts and Interventions

Group / Cohort
R-CHOP-14
R-mini-CHOP

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival (OS) death or progression/relapse, progression/relapse or treatment discontinuation.
Time Frame: through study completion, an average of 2 years
time from diagnosis to death
through study completion, an average of 2 years
Progression-free survival (PFS)
Time Frame: through study completion, an average of 2 years
time from diagnosis to death or progression/relapse
through study completion, an average of 2 years
Event-free survival (EFS)
Time Frame: through study completion, an average of 2 years
defined as time from diagnosis to death or progression/relapse or treatment discontinuation.
through study completion, an average of 2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Relative Dose intensity
Time Frame: within the treatment period, up to 36 weeks
Percentage of the dose intensity achieved divided by the intended dose intensity
within the treatment period, up to 36 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Saarland

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)

July 1, 2018

Primary Completion (Actual)

January 1, 2023

Study Completion (Actual)

November 1, 2023

Study Registration Dates

First Submitted

May 5, 2022

First Submitted That Met QC Criteria

November 20, 2023

First Posted (Actual)

November 29, 2023

Study Record Updates

Last Update Posted (Actual)

November 29, 2023

Last Update Submitted That Met QC Criteria

November 20, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DOME-80

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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