At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- mocravimod (drug)
- How long the study runs
- Study runs about 89 months (dates as stated)
- About the drug or intervention
- mocravimod — drug: S1PR modulator
- Patient visit burden
- Not specified by the sponsor
In plain English
This trial is testing a drug called mocravimod for adults with acute myeloid leukaemia (AML), a type of blood cancer. It is for people who are going to have a stem cell transplant from a donor. Mocravimod will be given alongside the transplant treatment and afterwards, to see if it helps. The trial is run by a company called Priothera SAS.
Who can take part
- Adults aged 18 to 75 with AML (but not a type called acute promyelocytic leukaemia)
- AML that is high-risk or intermediate-risk in first complete remission, or AML of any risk in second complete remission (including incomplete remission)
- Having a stem cell transplant planned from a fully matched related or unrelated donor (with no more than one mismatch), or from a half-matched (haploidentical) donor using a certain type of graft
- Conditioning (preparation) treatment with a certain score of at least 1.5
- Planned use of a TAC-based plan to prevent graft-versus-host disease
- Being well enough day-to-day (performance status score of 0 or 1)
Who may not be able to
- Using certain drugs to prevent graft-versus-host disease: ciclosporin (CsA), anti-thymocyte globulin (ATG), alemtuzumab or abatacept
- Diabetes
- Macular edema (swelling at the back of the eye) now or in the past, or swelling found during screening tests
- Uveitis (inflammation of the eye) now or in the past
- Problems with the heart, lungs, liver or kidneys
- Liver blood tests above a certain level, or kidneys not clearing waste well enough (creatinine clearance below 45 mL/min)
What taking part involves
- • Taking the study drug mocravimod alongside a donor stem cell transplant
- • Mocravimod is used both as extra (adjunctive) treatment and as ongoing (maintenance) treatment
- • Not stated — ask the trial team
Time commitment: Not stated — ask the trial team about how many visits, how long the trial lasts, and what taking part involves.
Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.
- Type of study
- Testing a treatment
- Ages
- 18 Years to 75 Years
- Who
- All
- Number of participants
- 366
- Started
- 2022-06-16
- Last checked
- 2026-07
Plain English Summary
What is this study?
- • Testing a new treatment for adult acute myeloid leukemia
- • Phase3 - 366 participants
- • This is a multi-center, randomized, double-blinded, placebo controlled trial
Who can take part?
- • Ages 18 Years to 75 Years
- • Diagnosed with adult acute myeloid leukemia
Where?
- • Birmingham - Queen Elizabeth Hospital
- • Cardiff - University Hospital of Wales, Cardiff
- • Glasgow - Queen Elizabeth University Hospital
- • London - University College Hospital,
- • +6 more UK sites
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
This is a multi-center, randomized, double-blinded, placebo controlled trial.
More detail
The purpose of this study is to evaluate the efficacy and safety of mocravimod as an adjunctive and maintenance treatment in adult acute myeloid leukemia (AML) patients undergoing allogeneic hematopoietic cell transplantation (HCT).
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years - 75 Years
- Who can join: All genders
What the study is looking for
- ✓Diagnosis of AML (excluding acute promyelocytic leukemia) according to the WHO 2022 classification of AML and...
- ✓European Leukemia Net (ELN) high-risk or intermediate-risk AML in CR1, or AML of any risk in CR2, \[CRi\] is also...
- ✓Planned allogeneic HCT from fully matched related or unrelated donor with no more than 1 antigen mismatch or planned...
- ✓Any conditioning regimen with a Transplant Conditioning Score (TCI) ≥ 1.5
- ✓Planned use of TAC-based GvHD prophylaxis
Who cannot take part
- ✗Use of CsA, anti-thymocyte globulin (ATG), alemtuzumab, abatacept for GvHD prophylaxis
- ✗Diagnosis of macular edema during screening
- ✗heart/lung/liver/kidney dysfunction
- ✗liver dysfunction as defined by aspartate aminotransferase (liver enzymes) and/or alanine aminotransferase (liver enzymes) \> 2.5 x...
- ✗kidney dysfunction with estimated creatinine clearance \< 45 mL/min by the Cockcroft-Gault formula
See the full criteria
Where Is This Study? (10 UK sites)
Queen Elizabeth Hospital
Birmingham B152TH, United Kingdom
University Hospital of Wales, Cardiff
Cardiff CF14 4XW, United Kingdom
Queen Elizabeth University Hospital
Glasgow G514TF, United Kingdom
University College Hospital,
London NW1 2BU, United Kingdom
Imperial College, London
London, United Kingdom
Manchester Royal Infirmary;Manchester University
Manchester M139WL, United Kingdom
Newcastle Upon Tyne Hospitals Norhtern Center for Cancer Care
Newcastle upon Tyne NE7 7DN, United Kingdom
Nottingham University Hospitals NHS Trust
Nottingham NG5 1PB, United Kingdom
Oxford University Hospitals
Oxford, United Kingdom
Royal Hallamshire Hospital
Sheffield S10 2JF, United Kingdom
How to Get in Touch
Malika Souquieres, MSc
Sponsor contactCONTACT
Jens Hasskarl, MD
Sponsor contactCONTACT
