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Clinical Trials in Denmark / NCT05245487
Recruiting Observational

Danish Elder Lymphoma Patient Hematopoietic Investigation

NCT05245487 · tracked via the Priya Life Science Denmark tracker
Sponsor
Copenhagen University Hospital, Rigshospitalet
Phase
Observational
Started
2022-01-01
Last updated
2023-12-22

Condition(s) studied

LymphomaChemotherapy-induced NeutropeniaChemotherapy-Related LeukemiaChemotherapeutic Toxicity

Investigational drug(s) / intervention(s)

DNA repair gene mutation analysis

DNA repair gene mutation analysis: Prospective monitoring of patients with next-generation sequencing for blood mutations

Study 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

Sex
ALL
Min age
60 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Dept. of Hematology, Rigshospitalet Copenhagen Denmark Recruiting

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05245487 on ClinicalTrials.gov ↗ ← All trials in Denmark