Assessing the Presence of CT-DNA in Lymphoma Associated HLH
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorNottingham University Hospitals NHS Trust
About this trial
Haemophagocytic lymphohistiocytosis (HLH) is a rare life-threatening blood disease which causes severe inflammation with symptoms similar to severe sepsis. It is hard to diagnose. The most common cause of HLH in adults is lymphoma (blood cancer). Outcomes for adults with HLH and cancer are serious, and most die after days or weeks because they have been diagnosed or treated too late. It is likely that many cases where patients died of HLH with no underlying cause actually had cancer.
Recently it has been found that patients with certain types of lymphoma have DNA which comes directly from their cancer (circulating tumour DNA; ctDNA). Aggressive lymphomas release a lot of ctDNA which can be detected in the blood of patients. This study will look for ctDNA in patients with HLH, and see if it is possible to use it to diagnose lymphoma earlier. Patients will provide a small additional blood sample for analysis. Diagnosing lymphoma more rapidly would mean more people could get the correct treatment for the lymphoma which has caused their HLH. They could receive the correct treatment sooner. Earlier diagnosis and treatment could improve survival for these patients.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Informed consent.
Age ≥18 years.
Clinically confirmed HLH.
High dose steroids and/or systemic anti-cancer therapy (SACT) for <72 hours for the current episode of HLH (anakinra is not considered SACT). Prior steroid use >14 days at the time of consent is permitted.
Disqualifiers
None
Trial population
Patients with HLH are usually unwell and hospitalised. Patients will be identified by the clinical (direct care) teams following a clinical diagnosis of HLH as part of routine clinical practice.
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Identification of lymphoma-specific mutations in ctDNA from patients with lymphoma driven HLH.
For those patients found to have lymphoma driven haemophagocytic syndrome we will assess whether we can find the presence of cell free tumour DNA in blood.
Time frame
Up to 2 yearsSecondary outcomes
1
Assess the utility of integrated data from clinical risk factors (IPI), up-front genotype, and radiological assessment (CT or PET-CT) with ctDNA findings.
We will use clinical, radiological and tumour mutation status to see if there is any correlation with the detection of cell free tumour DNA.
Time frame
Up to 2 years2
Assessing the feasibility of returning central laboratory data in a clinically useful timeframe.
Provided the primary outcome is successful we will see if the finding of cell free tumour DNA can be used as a clinical test to identify lymphoma in patients with HLH,
Time frame
Up to 2 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov