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

Old Age; Debility Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06150053
• Other study ID #: DOME-80
• Status: Completed
• Start date: July 1, 2018
• Est. completion date: November 1, 2023

Study information

• Verified date: November 2023
• Source: Universität des Saarlandes
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 79
• Est. completion date: November 1, 2023
• Est. primary completion date: January 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 80 Years and older

Eligibility

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

Related Conditions & MeSH terms

• DLBCL
• Frailty
• Old Age; Debility

Locations

Country	Name	City	State
Germany	Saarland University Medical Center	Homburg	Saarland

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Saarland

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival (OS) death or progression/relapse, progression/relapse or treatment discontinuation.	time from diagnosis to death	through study completion, an average of 2 years
Primary	Progression-free survival (PFS)	time from diagnosis to death or progression/relapse	through study completion, an average of 2 years
Primary	Event-free survival (EFS)	defined as time from diagnosis to death or progression/relapse or treatment discontinuation.	through study completion, an average of 2 years
Secondary	Relative Dose intensity	Percentage of the dose intensity achieved divided by the intended dose intensity	within the treatment period, up to 36 weeks