NCT05245487 Danish Elder Lymphoma Patient Hematopoietic Investigation
| NCT ID | NCT05245487 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Rigshospitalet, Denmark |
| Condition | Lymphoma |
| Study Type | OBSERVATIONAL |
| Enrollment | 300 participants |
| Start Date | 2022-01-01 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 300 participants in total. It began in 2022-01-01 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. 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.
Eligibility Criteria
Inclusion Criteria: * 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) Exclusion Criteria: * Unable to give written consent * Non-Danish citizens
Contact & Investigator
Simon Husby, MD PhD
PRINCIPAL INVESTIGATOR
Rigshospitalet, Denmark
Frequently Asked Questions
Who can join the NCT05245487 clinical trial?
This trial is open to participants of all sexes, aged 60 Years or older, studying Lymphoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05245487 currently recruiting?
Yes, NCT05245487 is actively recruiting participants. Contact the research team at simon.husby.01@regionh.dkZZZZZZ for enrollment information.
Where is the NCT05245487 trial being conducted?
This trial is being conducted at Copenhagen, Denmark.
Who is sponsoring the NCT05245487 clinical trial?
NCT05245487 is sponsored by Rigshospitalet, Denmark. The principal investigator is Simon Husby, MD PhD at Rigshospitalet, Denmark. The trial plans to enroll 300 participants.