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Intestinal Microbiota Transplant Prior to Allogeneic Stem Cell Transplant (MAST) Trial | Clinical Trials | Clareo Health

RECRUITINGPHASE2

Intestinal Microbiota Transplant Prior to Allogeneic Stem Cell Transplant (MAST) Trial

NCT06355583•Imperial College London

View on ClinicalTrials.gov

Summary

The goal of this clinical trial is to test the ability to restore gut microbiota to healthier levels in patients with blood cancers scheduled to have stem cell transplant. The main questions it aims to answer are: * Tolerability and acceptability of intestinal microbiota transplantation (IMT) versus placebo (as assessed via patient perspective questionnaires * Changes in gut microbiome diversity across all timepoints * Markers of general health, infective/microbiological and haematological outcomes including, days of fever, admission to intensive care unit, survival, non-relapsed mortality, and incidence of graft-versus-host disease across all time points measured. Participants will be asked at their routine follow up visits to, * Provide stool, urine and blood samples at the scheduled study visits * Complete questionnaires at selected visits * Swallow either Placebo or IMT capsules once at the second study visit which will occur 2 weeks prior to the stem cell transplant (+/-3 days) Researchers will compare IMT capsules and Placebo to investigate the change in gut microbiota diversity.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. \- Patients aged 18 years and over with a morphological documented diagnosis of ALL, acute myeloid leukemia (AML), AL of ambiguous lineage, myelodysplastic syndrome (MDS), chronic myelomonocytic leukemia (CMML), and CML in blast phase (Appendix 2) who are deemed fit for allogenic HCT with one of the following disease characteristics: ALL, AML, AL of ambiguous lineage
•* Patients in first complete remission (CR1) or second complete remission (CR2) including complete remission with incomplete blood count recovery with \< 5% blasts (Appendix 2)
•* Secondary leukaemia (defined as previous history of MDS, antecedent haematological disease or chemotherapy exposure) in CR1 or CR2 defined as \< 5% blasts (Appendix 2) MDS and CMML
•* Patients with advanced or high risk MDS with an International Prognostic Scoring System (IPSS-M) moderate high or higher including intermediate or high risk CMML who have \< 5% blasts at the time of randomisation (Appendix 2) CML in blast phase
•* Patients with Philadelphia or BCR:ABL1 positive chronic myeloid leukaemia (CML) in blast phase defined by the presence of ≥ 20% blasts in blood or bone marrow who have achieved second chronic phase with \< 5% blasts (Appendix 2).
•2. Patients must have completed minimum of two cycles of intensive chemotherapy prior to trial enrolment (Appendix 1)
•3. Patients must have received broad-spectrum antibiotics within 3 months prior to trial enrolment
•4. Patients must be considered suitable/fit to undergo allogeneic hematopoietic cell transplantation (HCT) as clinically judged by the Local investigator
•5. Patients with an Karnofsky performance status score 60 or above (Appendix 3)
•6. Females of and male patients of reproductive potential (i.e., not post-menopausal or surgically sterilised) must use appropriate, highly effective, contraception from the point of commencing therapy until 6 months after treatment
+6 more criteria

Exclusion Criteria

•1. Patients with contraindications to receiving allogeneic HCT.
•2. Female patients who are pregnant or breastfeeding. All women of childbearing potential must have a negative pregnancy test before commencing treatment.
•3. Adults of reproductive potential not willing to use appropriate, highly effective, contraception during the specified period.
•4. Patients with renal or hepatic impairment as clinically judged by the Local Investigator.
•5. Patients with active infection, HIV-positive or chronic active hepatitis B virus (HBV) or hepatitis C virus (HCV).
•6. Patients with a concurrent active malignancy or a prior malignancy, except lobular breast carcinoma in situ, fully resected basal cell or squamous cell carcinoma of skin or treated cervical carcinoma in situ, incidental histologic finding of prostate cancer (T1a or T1b using the tumour, node, metastasis (TNM) clinical staging system), previous MDS, CMML, Myeloproliferative neoplasms (MPN) resulting in secondary AML. Cancer treated with curative intent ≥ 5 years previously will be allowed. Cancer treated with curative intent \< 5 years previously will not be allowed.
•7. Swallowing difficulties that may preclude safe use of IMT capsules.
•8. Administration of IMT within 3 months prior to enrolment (probiotic administration prior to enrolment is allowed but should be recorded at screening).
•9. Patients taking probiotics after enrolment to the trial.
•10. Gastrointestinal disorders and diseases, including delayed gastric emptying, coeliac disease, cystic fibrosis, inflammatory bowel disease, irritable bowel syndrome, chronic diarrhoea, and colonic perforation or fistula.
+1 more criteria

Locations (8)

University Hospitals Birmingham NHS Foundation Trust

Birmingham, England, United Kingdom

Leeds Teaching Hospital NHS Trust

Leeds, England, United Kingdom

University College London Hospitals NHS Trust

London, England, United Kingdom

Kings College NHS Foundation Trust

London, England, United Kingdom

Imperial College Healthcare NHS Trust

London, England, United Kingdom

Royal Mardsen Hostpital

London, United Kingdom

Manchester University NHS Foundation Trust

Manchester, United Kingdom

Manchester University NHS Trust

Manchester, United Kingdom

Key Dates

Start Date

May 1, 2024

Primary Completion Date

February 1, 2026

Completion Date

May 1, 2027

Last Updated

April 17, 2025

Enrollment

ESTIMATED participants

Conditions

Acute Lymphoblastic LeukaemiaAcute Leukemia of Ambiguous LineageChronic Myeloid LeukemiaChronic Myelomonocytic LeukemiaMyelodysplastic SyndromeAcute Myeloid Leukemia

Interventions

EBX-102

DRUG

Placebo

DRUG

Contacts

Clinical Trials Coordinator

CONTACT

+442075943767 mast-trial@imperial.ac.uk

Julian Marchesi

CONTACT

02033126197 j.marchesi@imperial.ac.uk

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 17, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Intestinal Microbiota Transplant Prior to Allogeneic Stem Cell Transplant (MAST) Trial

Inclusion Criteria

Exclusion Criteria

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