Tests mocravimod with stem cell transplant for acute myeloid leukemia
Tests mocravimod alongside transplant in adults with acute myeloid leukemia.
Plain-language title generated from the registry record
Registry title: Mocravimod as Adjunctive and Maintenance Treatment in AML Patients Undergoing Allo-HCT
Key facts
- Where
- Gdansk, Katowice, Krakow, and Warsaw, PolandSee the 5 sites
- Phase
- Phase 3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT05429632, who can take part
Where in Poland
- Uniwersyteckie Centrum Kliniczne (UCK)Gdansk, PolandTaking people
- Slaski Uniwersytet Medyczny (SUM) w Katowicach - Samodzielny Publiczny Szpital Kliniczny im. Andrzeja Mieleckiego (SPSKM) - Slaskie Centrum Hematologii I Transplantacji SzpikuKatowice, PolandNo longer taking part
- Apteka NSSUKrakow, PolandNo longer taking part
- SP ZOZ Szpital Uniwersytecki w KrakowieKrakow, PolandNo longer taking part
- Centralny Szpital Kliniczny Apteka SzpitalnaWarsaw, PolandTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Priothera SAS
- Trial code
- NCT05429632
- Record updated
- 30 October 2026
- Original description
This is a multi-center, randomized, double-blinded, placebo controlled trial.Read full original descriptionShow less
Randomized, Double-blind, Placebo-controlled, Multi-center Phase III Study to Evaluate the Efficacy and Safety of Mocravimod as Adjunctive and Maintenance Treatment in Adult AML Patients Undergoing Allogeneic HCT
This is a multi-center, randomized, double-blinded, placebo controlled trial.
Inclusion: 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: 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; Use of CsA, anti-thymocyte globulin (ATG), alemtuzumab, abatacept for GvHD prophylaxis; Diagnosis of macular edema during screening.