Clinical trial · Observational
Assessing the Presence of CT-DNA in Lymphoma Associated HLH
Liquid Biopsy for the Identification of Malignancy Associated Haemophagocytic Lymphohistiocytosis (HLH)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Haemophagocytic Lymphohistiocytosis | — | UNRESOLVED | — |
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Identification of lymphoma-specific mutations in ctDNA from patients with lymphoma driven HLH.
- timeFrame
- Up to 2 years
- description
- 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.
Secondary outcomes (2)
- measure
- Assess the utility of integrated data from clinical risk factors (IPI), up-front genotype, and radiological assessment (CT or PET-CT) with ctDNA findings.
- timeFrame
- Up to 2 years
- description
- We will use clinical, radiological and tumour mutation status to see if there is any correlation with the detection of cell free tumour DNA.
- measure
- Assessing the feasibility of returning central laboratory data in a clinically useful timeframe.
- timeFrame
- Up to 2 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion criteria: * 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. * Patients with recurrent HLH may be included. * Patients already known to have underlying lymphoma, or have relapsed lymphoma may be included. Exclusion criteria: • Cause of HLH already known to be due to a non-malignant cause.
References
Publications (0)
Data not yet available