Current issues in oncology drug development, with a focus on Phase II trials.
Daniel J Sargent, Jeremy M G Taylor
https://pubmed.ncbi.nlm.nih.gov/19384696Actively Recruiting
Phase 2
Age: 18Years +
All Genders
ID06355583
Intestinal Microbiota Transplant Prior to Allogeneic Stem Cell Transplant (MAST) Trial
Led by Imperial College London · Updated on 2025-04-17
50
Participants Needed
8
Research Sites
64 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating the ability of intestinal microbiota transplantation (IMT) to restore healthier gut microbiota levels in patients with blood cancers who are scheduled for allogeneic stem cell transplant. This phase 2 clinical trial aims to compare the tolerability and acceptability of IMT capsules versus placebo, as well as assess changes in gut microbiome diversity and various health markers, including infection rates, graft-versus-host disease, and survival outcomes. The study is sponsored by Imperial College London and focuses on patients with specific blood cancers such as acute lymphoblastic leukemia and myelodysplastic syndrome. Participants will be randomly assigned to one of two groups. One group will swallow 10 IMT capsules containing viable microorganisms approximately two weeks before their stem cell transplant, while the other group will receive 10 placebo capsules with inactive ingredients that look identical to the IMT capsules. Both treatments are given once at the second study visit, maintaining blinding. The trial compares the effects of these capsules on gut microbiota diversity and clinical outcomes. Participants will provide stool, urine, and blood samples during scheduled visits before and up to one year after transplant. They will also complete questionnaires about their health and treatment experience. Researchers will monitor multiple measures, including gut microbiome diversity at many time points, infection occurrences, quality of life, organ function, and graft-versus-host disease severity. Follow-up assessments extend up to 365 days post-transplant to track overall survival and other health outcomes.
CONDITIONS
Brief Title
Intestinal Microbiota Transplant Prior to Allogeneic Stem Cell Transplant (MAST) Trial
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Patients aged 18 years and over with a documented diagnosis of ALL, AML, acute leukemia of ambiguous lineage, myelodysplastic syndrome, chronic myelomonocytic leukemia, or chronic myeloid leukemia in blast phase who are fit for allogeneic hematopoietic cell transplantation
- Patients in first or second complete remission with less than 5% blasts for certain leukemia types
- Patients with secondary leukemia in remission with less than 5% blasts
- Patients with advanced or high-risk myelodysplastic syndrome or chronic myelomonocytic leukemia with less than 5% blasts
- Patients with chronic myeloid leukemia in blast phase who have achieved second chronic phase with less than 5% blasts
- Completed at least two cycles of intensive chemotherapy prior to enrollment
- Received broad-spectrum antibiotics within 3 months prior to enrollment
- Considered suitable and fit for allogeneic hematopoietic cell transplantation
- Karnofsky performance status score of 60 or above
- Use of appropriate contraception for patients of reproductive potential during and for 6 months after treatment
- Provided written informed consent
- Willing and able to comply with scheduled study visits and laboratory tests
You will not qualify if you...
- Contraindications to receiving allogeneic hematopoietic cell transplantation
- Female patients who are pregnant or breastfeeding; women of childbearing potential must have a negative pregnancy test before treatment
- Adults of reproductive potential unwilling to use effective contraception
- Renal or hepatic impairment as judged by local investigator
- Active infection, HIV-positive, or chronic active hepatitis B or C infection
- Concurrent active malignancy or prior malignancy within 5 years except specified exceptions
- Difficulty swallowing capsules
- Received intestinal microbiota transplantation within 3 months prior to enrollment
- Taking probiotics after enrollment
- Gastrointestinal disorders including delayed gastric emptying, coeliac disease, cystic fibrosis, inflammatory bowel disease, irritable bowel syndrome, chronic diarrhea, colonic perforation or fistula
- Autoimmune disease requiring systemic steroids or immunosuppressants
- Significant bleeding disorder
- Anaphylactic food allergy
- Requirement for vasopressors
- Valvular heart disease or known structural heart defects
- Known severe allergy to capsule components
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - Up to 6 weeks
Participants are screened for eligibility to participate in the trial.
1 to 2 visits
Treatment
Duration - Single administration at approximately 2 weeks before stem cell transplantation
Participants swallow either EBX-102 capsules containing intestinal microorganisms or placebo capsules once approximately 2 weeks prior to stem cell transplantation.
1 visit (in-person)
Monitoring
Duration - Up to 12 months post stem cell transplantation
Participants are monitored for gut microbiota diversity, general health, infection outcomes, and quality of life through various assessments over one year following stem cell transplantation.
Approximately 8 follow-up visits at Day 0, Day 7, Day 14, Day 28, Day 100, Day 200, and Day 365 post transplantation
Trial Site Locations
Total: 8 locations
1
University Hospitals Birmingham NHS Foundation Trust
Birmingham, England, United Kingdom, B15 2WB
Actively Recruiting
2
Leeds Teaching Hospital NHS Trust
Leeds, England, United Kingdom, LS9 7TF
Not Yet Recruiting
3
University College London Hospitals NHS Trust
London, England, United Kingdom, NW1 2BU
Actively Recruiting
4
Kings College NHS Foundation Trust
London, England, United Kingdom, SE5 9RS
Actively Recruiting
5
Imperial College Healthcare NHS Trust
London, England, United Kingdom, W12 0NN
Actively Recruiting
6
Royal Mardsen Hostpital
London, United Kingdom, SW3 6JJ
Actively Recruiting
7
Manchester University NHS Foundation Trust
Manchester, United Kingdom, M13 9WL
Not Yet Recruiting
8
Manchester University NHS Trust
Manchester, United Kingdom, M13 9WL
Actively Recruiting
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Research Team
C
Clinical Trials Coordinator
J
Julian Marchesi
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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