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Looking for participantsPhase3

Mocravimod as Adjunctive and Maintenance Treatment in AML Patients Undergoing Allo-HCT

Sponsor: Priothera SAS

NCT ID: NCT05429632

View on ClinicalTrials.gov ↗

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).

Adult Acute Myeloid Leukemia

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

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
Inclusion Criteria: * Diagnosis of AML (excluding acute promyelocytic leukemia) according to the WHO 2022 classification of AML and related precursor neoplasm, including AML with myelodysplasia-related gene mutations * European Leukemia Net (ELN) high-risk or intermediate-risk AML in CR1, or AML of any risk in CR2, \[CRi\] is also allowable * Planned allogeneic HCT from fully matched related or unrelated donor with no more than 1 antigen mismatch or planned use of haploidentical donor using PBSC graft * Any conditioning regimen with a Transplant Conditioning Score (TCI) ≥ 1.5 * Planned use of TAC-based GvHD prophylaxis * age ≥ 18 years and ≤ 75 years * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 Exclusion Criteria: * Use of CsA, anti-thymocyte globulin (ATG), alemtuzumab, abatacept for GvHD prophylaxis * Diagnosis of macular edema during screening * Cardiac/pulmonary/hepatic/renal dysfunction * Hepatic dysfunction as defined by aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) \> 2.5 x upper limit of normal (ULN); or total bilirubin \> 1.5 mg/dL * Renal dysfunction with estimated creatinine clearance \< 45 mL/min by the Cockcroft-Gault formula * Diabetes mellitus * History or presence of uveitis at screening * History or diagnosis of macular edema

Where Is This Study? (10 UK sites)

Queen Elizabeth Hospital

Birmingham B152TH, United Kingdom

Recruiting
Site contact (verified)

University Hospital of Wales, Cardiff

Cardiff CF14 4XW, United Kingdom

Recruiting
Site contact (verified)

Queen Elizabeth University Hospital

Glasgow G514TF, United Kingdom

Recruiting
Site contact (verified)
David Irvine, MDDavid.Irvine7@nhs.scot

University College Hospital,

London NW1 2BU, United Kingdom

Recruiting
Site contact (verified)
Kate Stringaris, MDkate.stringaris@nhs.net

Imperial College, London

London, United Kingdom

ACTIVE_NOT_RECRUITING
Hospital R&D contact (matched)

Donna Copeland

donna.copeland@nhs.net---

Manchester Royal Infirmary;Manchester University

Manchester M139WL, United Kingdom

Recruiting
Site contact (verified)
Rahuman Salim, MDrahuman.salim@mft.nhs.uk

Newcastle Upon Tyne Hospitals Norhtern Center for Cancer Care

Newcastle upon Tyne NE7 7DN, United Kingdom

Recruiting
Site contact (verified)
Erin Hurst, MDerin.hurst1@nhs.net

Nottingham University Hospitals NHS Trust

Nottingham NG5 1PB, United Kingdom

ACTIVE_NOT_RECRUITING
Hospital R&D contact (matched)

Alison Lloyd

nuhnt.researchsponsor@nhs.net0115 9249924

Oxford University Hospitals

Oxford, United Kingdom

Recruiting
Site contact (verified)
Kirsty Sharplin, MDkirsty.sharplin@ouh.nhs.uk

Royal Hallamshire Hospital

Sheffield S10 2JF, United Kingdom

Recruiting
Site contact (verified)
Harpreet Knaur, MDHarpreet.Kaur12@nhs.net

How to Get in Touch

Malika Souquieres, MSc

Sponsor contact

CONTACT

+33 (0) 6 40 91 26 76 malika.souquieres@priothera.com

Jens Hasskarl, MD

Sponsor contact

CONTACT

+41 79 5432099 jens.hasskarl@priothera.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-07