The Microbiome in Blood Cancer and HLH

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age16-100
SponsorUniversity of Nottingham

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Informed consent

Age 16-100 years

A blood cancer or clinically confirmed HLH by H-score criteria

Disqualifiers

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.

Trial population

Participants will be recruited from haematology clinics and wards within Nottingham University Hospitals NHS Trust.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

750 Participants
are grouped into 3 trial groups
Group A: Diffuse Large B-cell lymphoma (DLBCL)
Group B: Follicular lymphoma (FL)
Group C: Haemophagocytic lymphohistiocytosis (HLH)

Trial outcomes

Primary outcomes

1

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.

The study aims to assess characteristic baseline signatures and/or dynamic changes within the immune system and gut microbiome/metabolome predicting toxicity, progression and survival adult patients with blood cancer or HLH. The study is exploratory.

Time frame
The patients actively participate in the study for a maximum of 56 days to allow serial sample collection.

Secondary outcomes

Other outcomes

Sponsors and contacts

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University of Nottingham

Lead sponsor

Nottingham University Hospitals NHS Trust

Collaborator

This trial is not recruiting at the moment. You can still explore other options: