LymphomaDELPHINCT05245487
Danish Elder Lymphoma Patient Hematopoietic Investigation
An observational study of Lymphoma and Chemotherapy-induced Neutropenia, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
Every year approximately 300 Danish patients die from lymphoma. The median age at diagnosis is 70 years. Lymphoma can be efficiently treated with chemotherapy, and potentially cured. However, sufficient treatment is often hampered by toxicity, especially in elderly patients. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Lymphoma, Chemotherapy-induced Neutropenia, Chemotherapy-Related Leukemia
- What is being tested?
- DNA repair gene mutation analysis
- How many people
- 300 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Jan 2022to 1 Jan 2035
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Danish citizens with r/r B-cell Non-Hodgkin lymphoma 60 years of age or older.
Who may be able to join
- Diagnosis of r/r B-cell Non-Hodgkin lymphoma
- In need of systemic treatment with second (2.) or higher line of active therapy for lymphoma
- 60 years of age or older (no age maximum)
Who cannot join
- Unable to give written consent
- Non-Danish citizens
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Kirsten Grønbæk, Prof. contact
Denmark1 site, 1 recruiting
- Recruiting
Dept. of Hematology, Rigshospitalet
Copenhagen
Simon Husby, MD PhD
Peter Brown, MD PhD
About this study
Official title: Chemotherapy-induced Genomic Damage in Elderly Patients With Lymphoma: Prevalence, Evolution, and Clinical Consequences
Every year approximately 300 Danish patients die from lymphoma. The median age at diagnosis is 70 years. Lymphoma can be efficiently treated with chemotherapy, and potentially cured. However, sufficient treatment is often hampered by toxicity, especially in elderly patients. It is also well known that the main risk factor for dying of lymphoma is age. New biologically targeted therapies with fewer side effects are becoming available for lymphoma treatment, however it is currently difficult to delineate which patients benefit from chemotherapy and which should be treated with novel expensive therapies.
Recently, it has been discovered that chemotherapy can provoke growth of patient blood cells with DNA mutations. This leads to increased rates of treatment side effects and excess mortality. These defects have so far only been examined in younger patients below 70 years of age, where they are found in roughly 10% of patients. It remains unknown to what extent elderly individuals are affected, but the investigators hypothesize that the proportion and negative effects are much larger.
Read more
Therefore, the investigators propose to investigate the frequency and evolution of these DNA mutations during chemotherapy in a prospective study of patients, who are either above 60 years of age and previously treated with chemotherapy for lymphoma in a nation-wide collaboration.
By using blood samples, advanced genetic analyses and patient-reported questionnaires, the investigators will study
- The prevalence of these mutations and their consequences for patient wellbeing, treatment side effects (such as anemia, infections etc.) and mortality
- The kinetics of these mutations during and after treatment, and explore possible evolutionary patterns of the inferred damages The investigators expect to include 300 patients in the study and that the first results will be ready in a timeframe of 4 years. The investigators hope to obtain new insights in the risk factors for physiological and mental health in lymphoma patients and thereby pave the way for improvements in wellbeing and survival of this underserved population.
Read the detailed description
DELPHI is prospective nationwide observational study investigating blood mutations in patients with lymphoma.
Inclusion criteria:
- Diagnosis of B-cell Non-Hodgkin lymphoma
- In need of systemic treatment with second (2.) or higher line of active therapy for lymphoma
- 60 years of age or older (no age maximum)
Exclusion criteria:
- Unable to give written consent
- Non-Danish citizens
Patients will be included by their treating physcian at their local department. All analyses are centralized. Blood samples for research puporses will be taken before, midway (tipically before 3rd / 4th series depending on regimen) and 4-8 weeks after treatment. Also QOL questionaires will be sent electronically to the patients. The results of the tests performed will blinded to the patient and the treating physician.
- Conditions
- Lymphoma, Chemotherapy-induced Neutropenia, Chemotherapy-Related Leukemia, Chemotherapeutic Toxicity
- Being tested
- DNA repair gene mutation analysis
- Medical subject headings
- Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DNA repair gene mutation analysisDiagnostic test
Prospective monitoring of patients with next-generation sequencing for blood mutations
What is being measured
The primary outcome is the main question the study is designed to answer.
Event-free survival (EFS)
EFS according to Revised Lugano Criteria
Measured: 2 years
Secondary outcomes (1)
Overall survival (OS)
OS
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2022
- Study start1 Jan 2022
- Primary completion31 Dec 2025 (estimated)
- Study completion1 Jan 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LymphomaStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 300 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Collaborators
- Aalborg University Hospital, Odense University Hospital, Aarhus University Hospital, Gødstrup Hospital, Vejle Hospital, Sonderborg Hospital, Danish Cancer Society, Zealand University Hospital
- Responsible party
- Principal investigator, Simon Husby, MD, PhD, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Simon Husby, MD PhD, Principal investigator, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05245487
- Sponsor's protocol ID
- DELPHI
- Acronym
- DELPHI
- Status last verified
- Apr 2023
- First submitted
- 8 Feb 2022
- Last updated
- 22 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chemotherapy-induced Genomic Damage in Elderly Patients With Lymphoma: Prevalence, Evolution, and Clinical Consequences
- ClinicalTrials.gov ID
- NCT05245487
- Acronym / sponsor ID
- DELPHI / DELPHI
- Conditions
- Lymphoma, Chemotherapy-induced Neutropenia, Chemotherapy-Related Leukemia, Chemotherapeutic Toxicity
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Collaborators
- Aalborg University Hospital, Odense University Hospital, Aarhus University Hospital, Gødstrup Hospital, Vejle Hospital, Sonderborg Hospital, Danish Cancer Society, Zealand University Hospital
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 1 Jan 2035 (estimated)
- First posted
- 18 Feb 2022 (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.
Every year approximately 300 Danish patients die from lymphoma. The median age at diagnosis is 70 years. Lymphoma can be efficiently treated with chemotherapy, and potentially cured. However, sufficient treatment is often hampered by toxicity, especially in elderly patients. It is also well known that the main risk factor for dying of lymphoma is age. New biologically targeted therapies with fewer side effects are becoming available for lymphoma treatment, however it is currently difficult to delineate which patients benefit from chemotherapy and which should be treated with novel expensive therapies.
Recently, it has been discovered that chemotherapy can provoke growth of patient blood cells with DNA mutations. This leads to increased rates of treatment side effects and excess mortality. These defects have so far only been examined in younger patients below 70 years of age, where they are found in roughly 10% of patients. It remains unknown to what extent elderly individuals are affected, but the investigators hypothesize that the proportion and negative effects are much larger.
Therefore, the investigators propose to investigate the frequency and evolution of these DNA mutations during chemotherapy in a prospective study of patients, who are either above 60 years of age and previously treated with chemotherapy for lymphoma in a nation-wide collaboration.
By using blood samples, advanced genetic analyses and patient-reported questionnaires, the investigators will study
- The prevalence of these mutations and their consequences for patient wellbeing, treatment side effects (such as anemia, infections etc.) and mortality
- The kinetics of these mutations during and after treatment, and explore possible evolutionary patterns of the inferred damages The investigators expect to include 300 patients in the study and that the first results will be ready in a timeframe of 4 years. The investigators hope to obtain new insights in the risk factors for physiological and mental health in lymphoma patients and thereby pave the way for improvements in wellbeing and survival of this underserved population.
Detailed description
DELPHI is prospective nationwide observational study investigating blood mutations in patients with lymphoma.
Inclusion criteria:
- Diagnosis of B-cell Non-Hodgkin lymphoma
- In need of systemic treatment with second (2.) or higher line of active therapy for lymphoma
- 60 years of age or older (no age maximum)
Exclusion criteria:
- Unable to give written consent
- Non-Danish citizens
Patients will be included by their treating physcian at their local department. All analyses are centralized. Blood samples for research puporses will be taken before, midway (tipically before 3rd / 4th series depending on regimen) and 4-8 weeks after treatment. Also QOL questionaires will be sent electronically to the patients. The results of the tests performed will blinded to the patient and the treating physician.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Danish citizens with r/r B-cell Non-Hodgkin lymphoma 60 years of age or older.
Key inclusion criteria (3 listed)
- Diagnosis of r/r B-cell Non-Hodgkin lymphoma
- In need of systemic treatment with second (2.) or higher line of active therapy for lymphoma
- 60 years of age or older (no age maximum)
Key exclusion criteria (2 listed)
- Unable to give written consent
- Non-Danish citizens
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DNA repair gene mutation analysisProspective monitoring of patients with next-generation sequencing for blood mutations | Diagnostic test | – |
Primary outcome
Event-free survival (EFS)
Time frame: 2 years
EFS according to Revised Lugano Criteria
1 secondary outcome
Overall survival (OS)
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2023.
- Individual participant dataSharing planned: Undecided
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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.
Kirsten Grønbæk, Prof. contact
Simon Husby, MD PhD principal investigator
Copenhagen University Hospital, Rigshospitalet
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 Lymphoma and Chemotherapy-induced Neutropenia, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
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 2 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: looking for participants now, as of the sponsor's last update on 22 Dec 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 Denmark. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Simon Husby, MD PhD (+45 3545 6060, simon.husby.01@regionh.dkZZZZZZ), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Event-free survival (EFS) (time frame: 2 years). 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 22 Dec 2023.