Health TrialsbyHealthPanel

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

ConditionAdult Acute Myeloid Leukemia
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorPriothera SAS

About this trial

This is a multi-center, randomized, double-blinded, placebo controlled trial.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • mocravimod

    Drug

    S1PR modulator

Treatment groups

366 Participants
are divided into 3 treatment groups
Group A: 3mg mocravimod armExperimental treatment 1 intervention
Group B: 1mg mocravimod armExperimental treatment 1 intervention
Group C: Placebo armPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Relapse-free survival (RFS)

To compare the efficacy of mocravimod to that of placebo

Time frame
12 months

Secondary outcomes

1

Overall survival (OS)

To compare mocravimod's effect on overall survival (OS) to that of placebo

Time frame
24 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Priothera SAS

Lead sponsor

Source ClinicalTrials.gov
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