DLBCLNCT06150053
Dose Dense Chemotherapy in Elderly Patients > 80 Years Old With DLBCL
An observational study of DLBCL and Old Age; Debility, run by University Hospital, Saarland at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 80 years and older
- Conditions the study is for
- DLBCL, Old Age; Debility
- How many people
- 79 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jul 2018to 1 Nov 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 80 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Elderly patients with DLBCL
Who may be able to join
- histologically proven, untreated diffus large B-cell lymphoma (DLBCL)
- diagnosis between 2005 - 2019
- age ≥80 at diagnosis
Who cannot join
- diagnosis revision at a later timepoint
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- DLBCL, Old Age; Debility
- Medical subject headings
- Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| R-CHOP-14 | Not described | |
| R-mini-CHOP | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival (OS) death or progression/relapse, progression/relapse or treatment discontinuation.
time from diagnosis to death
Measured: through study completion, an average of 2 years
Progression-free survival (PFS)
time from diagnosis to death or progression/relapse
Measured: 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.
Measured: through study completion, an average of 2 years
Secondary outcomes (1)
Relative Dose intensity
Percentage of the dose intensity achieved divided by the intended dose intensity
Measured: within the treatment period, up to 36 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2023
- Study start1 Jul 2018
- Primary completion1 Jan 2023
- Study completion1 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DLBCLStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Saarland
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Konstantinos Christofyllakis, University Hospital, Saarland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06150053
- Sponsor's protocol ID
- DOME-80
- Status last verified
- Nov 2023
- First submitted
- 5 May 2022
- Last updated
- 29 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dose Dense Chemotherapy in Elderly Patients > 80 Years Old With DLBCL
- ClinicalTrials.gov ID
- NCT06150053
- Acronym / sponsor ID
- DOME-80
- Conditions
- DLBCL, Old Age; Debility
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- University Hospital, SaarlandUniversity, hospital or other
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 1 Jan 2023 (actual)
- Study completion
- 1 Nov 2023 (actual)
- First posted
- 29 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| R-CHOP-14 | – | – |
| R-mini-CHOP | – | – |
Who may qualify
- Ages
- 80 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Elderly patients with DLBCL
Key inclusion criteria (3 listed)
- histologically proven, untreated diffus large B-cell lymphoma (DLBCL)
- diagnosis between 2005 - 2019
- age ≥80 at diagnosis
Key exclusion criteria (1 listed)
- diagnosis revision at a later timepoint
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Progression-free survival (PFS)
Time frame: through study completion, an average of 2 years
time from diagnosis to death or progression/relapse
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.
1 secondary outcome
Relative Dose intensity
Time frame: within the treatment period, up to 36 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of DLBCL and Old Age; Debility, run by University Hospital, Saarland at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (OS) death or progression/relapse, progression/relapse or treatment discontinuation. (time frame: through study completion, an average of 2 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2023.