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Completed

NCT Number: NCT06150053

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

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.

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Key information

Conditions

DLBCL Frailty Old Age; Debility Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

80 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Saarland University Medical Center

Homburg, Saarland, 66424, Germany

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Primary outcomes

  1. 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

  2. Progression-free survival (PFS)

    Time frame: through study completion, an average of 2 years

    time from diagnosis to death or progression/relapse

  3. 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.

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

University Hospital, Saarland

Other

Registry information

Important dates

Study start
2018
Primary completion
2023
Study completion
2023
First posted
Nov 29, 2023
Registry last updated
Nov 29, 2023

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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