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Danish Elder Lymphoma Patient Hematopoietic Investigation (DELPHI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05245487
Recruitment Status : Recruiting
First Posted : February 18, 2022
Last Update Posted : December 22, 2023
Sponsor:
Collaborators:
Aalborg University Hospital
Odense University Hospital
Aarhus University Hospital
Gødstrup Hospital
Vejle Hospital
Sonderborg Hospital
Danish Cancer Society
Zealand University Hospital
Information provided by (Responsible Party):
Simon Husby, MD, PhD, Rigshospitalet, Denmark

Study Description
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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.

Condition or disease Intervention/treatment
Lymphoma Chemotherapy-induced Neutropenia Chemotherapy-Related Leukemia Chemotherapeutic Toxicity Diagnostic Test: DNA repair gene mutation analysis

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
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 10 Years
Official Title: Chemotherapy-induced Genomic Damage in Elderly Patients With Lymphoma: Prevalence, Evolution, and Clinical Consequences
Actual Study Start Date : January 1, 2022
Estimated Primary Completion Date : December 31, 2025
Estimated Study Completion Date : January 1, 2035

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Groups and Cohorts
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Intervention Details:
  • Diagnostic Test: DNA repair gene mutation analysis
    Prospective monitoring of patients with next-generation sequencing for blood mutations

Outcome Measures
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Primary Outcome Measures :
  1. Event-free survival (EFS) [ Time Frame: 2 years ]
    EFS according to Revised Lugano Criteria


Secondary Outcome Measures :
  1. Overall survival (OS) [ Time Frame: 2 years ]
    OS


Biospecimen Retention:   Samples With DNA
Blood samples

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Danish citizens with r/r B-cell Non-Hodgkin lymphoma 60 years of age or older.
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
Contacts and Locations
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05245487


Contacts
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Contact: Simon Husby, MD PhD +45 3545 6060 simon.husby.01@regionh.dkZZZZZZ
Contact: Kirsten Grønbæk, Prof.

Locations
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Denmark
Dept. of Hematology, Rigshospitalet Recruiting
Copenhagen, Denmark
Contact: Simon Husby, MD PhD         
Principal Investigator: Peter Brown, MD PhD         
Sponsors and Collaborators
Rigshospitalet, Denmark
Aalborg University Hospital
Odense University Hospital
Aarhus University Hospital
Gødstrup Hospital
Vejle Hospital
Sonderborg Hospital
Danish Cancer Society
Zealand University Hospital
Investigators
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Principal Investigator: Simon Husby, MD PhD Rigshospitalet, Denmark
More Information
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Responsible Party: Simon Husby, MD, PhD, MD, PhD, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT05245487    
Other Study ID Numbers: DELPHI
First Posted: February 18, 2022    Key Record Dates
Last Update Posted: December 22, 2023
Last Verified: April 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lymphoma
Neutropenia
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
 Immune System Diseases
Agranulocytosis
Leukopenia
Cytopenia
Hematologic Diseases
Leukocyte Disorders