The Microbiome in Blood Cancer and HLH

NCT06734624 | Not Yet Recruiting

• 1 other identifier: 24059
• Study Type: observational
• Target: 750
• Locations: 1 country
• Sites: 1

Brief Summary

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

Diffuse Large B Cell Lymphoma (DLBCL); Follicular Lymphoma (FL); Haemophagocytic Lymphohistiocytosis

Keywords

Microbiome; DLBCL; FL; HLH

Outcome Measures

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.

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

Study Arms (3)

Diffuse Large B-cell lymphoma (DLBCL)

Patents with DLBCL receiving CART or Bispecific antibody treatment

Follicular lymphoma (FL)

Patents with newly diagnosed FL, or FL receiving CART or Bispecific antibody treatment

Haemophagocytic lymphohistiocytosis (HLH)

Patients who develop HLH with any underlying trigger factor.

Eligibility Criteria

• Age: 16 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Informed consent
• Age 16-100 years
• A blood cancer or clinically confirmed HLH by H-score criteria

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Nottingham: lead
• Nottingham University Hospitals NHS Trust: collaborator

Study Sites (1)

University of Nottingham

Nottingham, Nottinghamshire, NG7 2RD, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITH DNA

Plasma and stool samples at three timepoints for each patient enrolled.

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse; Lymphoma, Follicular; Lymphohistiocytosis, Hemophagocytic

Condition Hierarchy (Ancestors)

Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Histiocytosis, Non-Langerhans-Cell; Histiocytosis

Study Officials

• Mark J Bishton, MBChB, MRCP, FRCPath, PhD

  University of Nottingham

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mark J Bishton, MBChB, MRCP, FRCPath, PhD

CONTACT

+44 (0)1159691169; mark.bishton@nottingham1.ac.uk

Tanya M Monaghan, MD, PhD

CONTACT

0115 9249924; Tanya.Monaghan@nottingham.ac.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 11, 2024
• First Posted: December 16, 2024
• Study Start: January 1, 2025
• Primary Completion (Estimated): December 31, 2039
• Study Completion (Estimated): December 1, 2044
• Last Updated: December 16, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share

Locations

GB (1)