Danish Elder Lymphoma Patient Hematopoietic Investigation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: DNA repair gene mutation analysis.
- Who it may be relevant to
- Registry conditions: Lymphoma, Chemotherapy-induced Neutropenia, Chemotherapy-Related Leukemia, Chemotherapeutic Toxicity. Basic parameters: from 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Denmark
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Chemotherapy-induced Genomic Damage in Elderly Patients With Lymphoma: Prevalence, Evolution, and Clinical Consequences
Overview
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.
Interventions
- Diagnostic test DNA repair gene mutation analysis
Prospective monitoring of patients with next-generation sequencing for blood mutations
Primary outcome measures
- Event-free survival (EFS) [Time frame: 2 years]
Secondary outcome measures (1)
- Overall survival (OS) [Time frame: 2 years]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Denmark · 1 center
- Dept. of Hematology, Rigshospitalet — Copenhagen
Identifiers
NCT: NCT05245487 · DELPHI