Danish Elder Lymphoma Patient Hematopoietic Investigation

NCT05245487 | Recruiting

• 1 other identifier: DELPHI
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Lymphoma; Chemotherapy-induced Neutropenia; Chemotherapy-Related Leukemia; Chemotherapeutic Toxicity

Outcome Measures

Primary Outcomes (1)

• Event-free survival (EFS)

  EFS according to Revised Lugano Criteria

  2 years

Secondary Outcomes (1)

• Overall survival (OS)

  2 years

Interventions

DNA repair gene mutation analysis DIAGNOSTIC_TEST

Prospective monitoring of patients with next-generation sequencing for blood mutations

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Danish citizens with r/r B-cell Non-Hodgkin lymphoma 60 years of age or older.

You may qualify if:

• 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
• years of age or older (no age maximum)

You may not qualify if:

• Unable to give written consent
• Non-Danish citizens

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead
• Aalborg University Hospital: collaborator
• Odense University Hospital: collaborator
• Aarhus University Hospital: collaborator
• Gødstrup Hospital: collaborator
• Vejle Hospital: collaborator
• Sonderborg Hospital: collaborator
• Danish Cancer Society: collaborator
• Zealand University Hospital: collaborator

Study Sites (1)

Dept. of Hematology, Rigshospitalet

Copenhagen, Denmark

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples

MeSH Terms

Conditions

Lymphoma

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Simon Husby, MD PhD

  Rigshospitalet, Denmark

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Simon Husby, MD PhD

CONTACT

+45 3545 6060; simon.husby.01@regionh.dkZZZZZZ

Kirsten Grønbæk, Prof.

CONTACT

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: February 8, 2022
• First Posted: February 18, 2022
• Study Start: January 1, 2022
• Primary Completion: December 31, 2025
• Study Completion (Estimated): January 1, 2035
• Last Updated: December 22, 2023

Record last verified: 2023-04

Locations

DK (1)