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New treatment option for Acute Lymphoblastic Leukaemia
Official title Intestinal Microbiota Transplant Prior to Allogeneic Stem Cell Transplant (MAST) Trial
ClinicalTrials.gov ID: NCT06355583
What this study is testing
What is EBX-102?
EBX-102 is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for acute lymphoblastic leukaemia.
Also referred to as IMT capsules.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- \- Patients aged 18 years and over with a morphological documented diagnosis of ALL, acute myeloid leukemia (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...
- Secondary leukaemia (defined as previous history of MDS, antecedent haematological disease or chemotherapy exposure) in CR1 or CR2 defined as \< 5%...
- Patients with advanced or high risk MDS with an International Prognostic Scoring System (IPSS-M) moderate high or higher including intermediate or...
- Patients with Philadelphia or BCR:ABL1 positive chronic myeloid leukaemia (CML) in blast phase defined by the presence of ≥ 20% blasts in blood or...
You likely can't join if
- Patients with contraindications to receiving allogeneic HCT.
- Female patients who are pregnant or breastfeeding. All women of childbearing potential must have a negative pregnancy test before commencing...
- Adults of reproductive potential not willing to use appropriate, highly effective, contraception during the specified period.
- Patients with renal or hepatic impairment as clinically judged by the Local Investigator.
- Patients with active infection, HIV-positive or chronic active hepatitis B virus (HBV) or hepatitis C virus (HCV).
- Patients with a concurrent active malignancy or a prior malignancy, except lobular breast carcinoma in situ, fully resected basal cell or squamous...
See the full eligibility criteria
- \- 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...
- 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...
- 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...
- Patients must have completed minimum of two cycles of intensive chemotherapy prior to trial enrolment (Appendix 1)
- Patients must have received broad-spectrum antibiotics within 3 months prior to trial enrolment
- Patients must be considered suitable/fit to undergo allogeneic hematopoietic cell transplantation (HCT) as clinically judged by the Local investigator
- Patients with an Karnofsky performance status score 60 or above (Appendix 3)
- 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...
- Patients have given written informed consent
- Patients willing and able to comply with scheduled study visits and laboratory tests
- Patients with contraindications to receiving allogeneic HCT.
- Female patients who are pregnant or breastfeeding. All women of childbearing potential must have a negative pregnancy test before commencing treatment.
- Adults of reproductive potential not willing to use appropriate, highly effective, contraception during the specified period.
- Patients with renal or hepatic impairment as clinically judged by the Local Investigator.
- Patients with active infection, HIV-positive or chronic active hepatitis B virus (HBV) or hepatitis C virus (HCV).
- 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...
- Swallowing difficulties that may preclude safe use of IMT capsules.
- Administration of IMT within 3 months prior to enrolment (probiotic administration prior to enrolment is allowed but should be recorded at screening).
- Patients taking probiotics after enrolment to the trial.
- 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.
- Any autoimmune disease requiring, or that may require, systemic treatment with steroids and/or other immunosuppressants/immunomodulators.
- Significant bleeding disorder (ALL, AML, AL of ambiguous lineage, MDS, CMML, and CML satisfying inclusion criteria are not excluded).
- Anaphylactic food allergy.
- Requirement for vasopressors.
- Valvular heart disease or known structural defects of the heart.
- Known severe allergy to capsule components.
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, England, United Kingdom
- Leeds, England, United Kingdom
- London, England, United Kingdom
- London, United Kingdom
- Manchester, United Kingdom
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, England, United Kingdom; Leeds, England, United Kingdom; London, England, United Kingdom; London, United Kingdom; Manchester, United Kingdom. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.