Dose Dense Chemotherapy in Elderly Patients > 80 Years Ol... | NCT06150053

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

NCT06150053

Sponsor

University Hospital, Saarland

Status

Completed

Last Update Posted

Nov 29, 2023Actual

Enrollment

79Actual

Phase

Not provided

Conditions

DLBCL
Old Age; Debility

Interventions

Not provided

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 1, 2018Actual

Primary Completion Date

Jan 1, 2023Actual

Completion Date

Nov 1, 2023Actual

First Submitted Date

May 5, 2022

First Submission Date that Met QC Criteria

Nov 20, 2023

First Posted Date

Nov 29, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 20, 2023

Last Update Posted Date

Nov 29, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Konstantinos Christofyllakis, Consultant, University Hospital, SaarlandPrincipal Investigator

Lead Sponsor

University Hospital, SaarlandOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

79Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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
Progression-free survival (PFS)	time from diagnosis to death or progression/relapse	through study completion, an average of 2 years
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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

80 Years

Maximum Age

Not provided

Standard Ages

Older Adult

Study Population

Elderly patients with DLBCL

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Saarland University Medical Center		Homburg	Saarland	66424	Germany

Condition Browse Module

MeSH Terms

ID	Term
D000073496	Frailty

Ancestor Terms

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided