Trial Title:
Intestinal Microbiota Transplant Prior to Allogeneic Stem Cell Transplant (MAST) Trial
NCT ID:
NCT06355583
Condition:
Acute Lymphoblastic Leukaemia
Acute Leukemia of Ambiguous Lineage
Chronic Myeloid Leukemia
Chronic Myelomonocytic Leukemia
Myelodysplastic Syndrome
Acute Myeloid Leukemia
Conditions: Official terms:
Leukemia
Leukemia, Myeloid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Leukemia, Myelomonocytic, Chronic
Leukemia, Myelomonocytic, Juvenile
Myelodysplastic Syndromes
Conditions: Keywords:
MAST
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Prevention
Masking:
Triple (Participant, Care Provider, Investigator)
Intervention:
Intervention type:
Drug
Intervention name:
EBX-102
Description:
EBX-102 is a white size 0 gastro-resistant hydroxypropyl methylcellulose (HPMC) capsule
containing communities of dried, intestinal microorganisms extracted from rigorously
screened pooled human stool samples obtained from volunteer accredited donors.
Arm group label:
EBX-102-02
Other name:
IMT capsules
Intervention type:
Drug
Intervention name:
Placebo
Description:
The capsules contain inactive ingredients microcrystalline cellulose and magnesium
stearate.
Arm group label:
Placebo
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.
Criteria for eligibility:
Criteria:
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
7. Patients have given written informed consent
8. Patients willing and able to comply with scheduled study visits and laboratory tests
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.
11. Any autoimmune disease requiring, or that may require, systemic treatment with
steroids and/or other immunosuppressants/immunomodulators.
12. Significant bleeding disorder (ALL, AML, AL of ambiguous lineage, MDS, CMML, and CML
satisfying inclusion criteria are not excluded).
13. Anaphylactic food allergy.
14. Requirement for vasopressors.
15. Valvular heart disease or known structural defects of the heart.
16. Known severe allergy to capsule components.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University Hospitals Birmingham NHS Foundation Trust
Address:
City:
Birmingham
Zip:
B15 2WB
Country:
United Kingdom
Contact:
Last name:
Senior Haematology Research Sister
Phone:
01213714351
Email:
HaematologyCancerResearch@uhb.nhs.uk
Investigator:
Last name:
Francesca Kinsella
Email:
Principal Investigator
Facility:
Name:
Leeds Teaching Hospital NHS Trust
Address:
City:
Leeds
Zip:
LS9 7TF
Country:
United Kingdom
Contact:
Last name:
Principal Investigator
Phone:
01132068561
Email:
anjum.khan@nhs.net
Facility:
Name:
University College London Hospitals NHS Trust
Address:
City:
London
Zip:
NW1 2BU
Country:
United Kingdom
Contact:
Last name:
BMT Trials
Email:
uclh.bmttrials@nhs.net
Investigator:
Last name:
Panagiotis Kottaridis
Email:
Principal Investigator
Facility:
Name:
Kings College NHS Foundation Trust
Address:
City:
London
Zip:
SE5 9RS
Country:
United Kingdom
Contact:
Last name:
Principal Investigator
Email:
p.krishnamurthy@nhs.net
Investigator:
Last name:
Pramila Krishnamurthy
Email:
Principal Investigator
Facility:
Name:
Imperial College Healthcare NHS Trust
Address:
City:
London
Zip:
W12 0NN
Country:
United Kingdom
Contact:
Last name:
Senior Research Operations Manager
Phone:
02037048452
Email:
Eleni.Vourvou@nhs.net
Facility:
Name:
Royal Mardsen Hostpital
Address:
City:
London
Zip:
SW3 6JJ
Country:
United Kingdom
Contact:
Last name:
Haemato-Oncology Department
Phone:
0208915 6187
Email:
Emma.Nicholson@rmh.nhs.uk
Investigator:
Last name:
Emma Nicholson
Email:
Principal Investigator
Start date:
April 15, 2024
Completion date:
May 1, 2027
Lead sponsor:
Agency:
Imperial College London
Agency class:
Other
Source:
Imperial College London
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06355583
