A trial looking at the effectiveness of a treatment made from donated stool samples to see if gut bacteria can be increased in patients having a transplant for blood cancer.

Not Applicable

• Conditions: The study population will include patients with, acute myeloid leukaemia (AML), acute lymphoblastic leukaemia (ALL), acute leukaemia (AL) of ambiguous lineage, chronic lymphocytic leukaemia (CLL), Chronic myeloid leukaemia (CML), chronic myelomonocytic leukaemia (CMML), myelodysplastic syndrome (MDS); Cancer

• Registration Number: ISRCTN13241761
• Lead Sponsor: Imperial College London

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-10-09
• Last Update Posted: 13 November 2023
• Study Completion: 2026-08-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1. Patients aged 18 years and over with a morphological documented diagnosis of ALL, AML, AL of ambiguous linage, MDS, CMML, and CML in blast phase who are deemed fit for allogenic HSCT with one of the following disease characteristics:
ALL, AML, AL of ambiguous linage
1.1. Patients in first complete remission (CR1) or second complete remission (CR2) including complete remission with incomplete blood count recovery with < 5% blasts
1.2. Secondary leukaemia (defined as previous history of MDS, antecedent haematological disease or chemotherapy exposure) in CR1 or CR2 defined as < 5% blasts
MDS and CMML
1.3. Patients with advanced or high-risk MDS with an IPSS-M moderate high or higher including intermediate or high-risk CMML who have < 5% blasts at the time of randomisation
CML in the blast phase
1.4. Patients with Philadelphia or BCR:ABL1 positive chronic myeloid leukaemia (CML) in blast phase defined by the presence of = 20% blasts in the blood or bone marrow who have achieved second chronic phase with < 5% blasts (Appendix 2).
2. Patients must have completed a 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 HSCT as clinically judged by the Local investigator
5. Patients with a Karnofsky performance status score of 60 or above (Appendix 3)
6. Females 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 HSCT
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 HBV or 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 the skin or treated cervical carcinoma in situ, an incidental histologic finding of prostate cancer (T1a or T1b using the tumour, node, metastasis (TNM) clinical staging system), previous MDS, CMML, 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 the 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 in the trial
10. Chronic intestinal disease, including coeliac disease, cystic fibrosis, inflammatory bowel disease, irritable bowel syndrome, and chronic diarrhoea
11. Known severe allergy to capsule components

Study & Design

• Study Type: Interventional
• Study Design: Not specified