NCT05429632 Mocravimod as Adjunctive and Maintenance Treatment in AML Patients Undergoing Allo-HCT
| NCT ID | NCT05429632 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Priothera SAS |
| Condition | Adult Acute Myeloid Leukemia |
| Study Type | INTERVENTIONAL |
| Enrollment | 366 participants |
| Start Date | 2022-06-16 |
| Primary Completion | 2027-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 366 participants in total. It began in 2022-06-16 with a primary completion date of 2027-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This is a multi-center, randomized, double-blinded, placebo controlled trial.
Eligibility 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
Contact & Investigator
Marcos DeLima, MD
PRINCIPAL INVESTIGATOR
The Ohio State University Comprehensive Cancer Center
Frequently Asked Questions
Who can join the NCT05429632 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Adult Acute Myeloid Leukemia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05429632 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 366 participants.
Is NCT05429632 currently recruiting?
Yes, NCT05429632 is actively recruiting participants. Contact the research team at malika.souquieres@priothera.com for enrollment information.
Where is the NCT05429632 trial being conducted?
This trial is being conducted at Birmingham, United States, Gilbert, United States, Duarte, United States, Los Angeles, United States and 11 additional locations.
Who is sponsoring the NCT05429632 clinical trial?
NCT05429632 is sponsored by Priothera SAS. The principal investigator is Marcos DeLima, MD at The Ohio State University Comprehensive Cancer Center. The trial plans to enroll 366 participants.
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