Clinical trial · Observational
The Microbiome in Blood Cancer and HLH
Using Blood and Stool Samples From Patients With Blood Cancer and/or Haemophagocytic Lymphohistiocytosis to Study the Influence of Host Microbial Factors on Toxicity and Survival
- 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)
The bacteria and viruses in the bowel (gut microbiota; GM) have powerful effects on the immune system. GM changes are seen in patients with auto-immune diseases, where the immune system attacks normal tissues, and cancer, and for those with some forms of blood cancer, and appears to affect both responses to, and side-effects of treatment. The investigators want to examine the GM and the associated small molecules (metabolites) in adults with different forms of blood cancer, particularly those undergoing immunotherapy, those with have newly diagnosed follicular lymphoma, and also those with a severe hyperinflammatory disorder which causes problems similar to sepsis called Haemophagocytic lymphohistiocytosis (HLH), which is also often caused by an underlying lymphoma. The investigators want to collect blood and stool samples from patients and use the results of tests already performed in the NHS as well as recording how well patients responded to treatment. The samples will be used to identify novel targets within the GM and associated metabolites which contribute to side effects of, or response to immunotherapy, or are responsible for causing HLH which can be targeted to make treatment better tolerated. For patients with newly diagnosed indolent lymphoma the aim is to see if there are differences which may account for patients needing early or late treatment, or no treatment ever.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Diffuse Large B Cell Lymphoma (DLBCL) | Diffuse Large B-Cell Lymphoma | ALIAS | 0.90 |
| Follicular Lymphoma (FL) | Follicular Lymphoma | ONTOLOGY_EXACT | 0.85 |
| Haemophagocytic Lymphohistiocytosis | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (3)
- label
- Diffuse Large B-cell lymphoma (DLBCL)
- description
- Patents with DLBCL receiving CART or Bispecific antibody treatment
- label
- Follicular lymphoma (FL)
- description
- Patents with newly diagnosed FL, or FL receiving CART or Bispecific antibody treatment
- label
- Haemophagocytic lymphohistiocytosis (HLH)
- description
- Patients who develop HLH with any underlying trigger factor.
Primary outcomes (1)
- measure
- To collect blood and stool samples from patients with blood cancer and/or HLH to enable the study of the influence of the host immune system and gut microbiota on toxicity and survival.
- timeFrame
- The patients actively participate in the study for a maximum of 56 days to allow serial sample collection.
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 16 Years
- Maximum age
- 100 Years
Show eligibility criteria text
Inclusion Criteria: * Informed consent * Age 16-100 years * A blood cancer or clinically confirmed HLH by H-score criteria Exclusion Criteria: * Known positive HIV, hepatitis B and/or hepatitis C serology (as laboratory not accredited to handle high-risk samples). * Active communicable disease eg SARS-CoV-2, monkeypox.
References
Publications (0)
Data not yet available