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

RECRUITINGPhase 3Sponsored by Priothera SAS
Actively Recruiting
PhasePhase 3
SponsorPriothera SAS
Started2022-06-16
Est. completion2027-05
Eligibility
Age18 Years – 75 Years
Healthy vol.Accepted
Locations21 sites
View on ClinicalTrials.gov →

NCT05429632

Summary

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

Eligibility

Age: 18 Years – 75 YearsHealthy volunteers accepted
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

Conditions2

Adult Acute Myeloid LeukemiaCancer

Locations21 sites

University of Alabama Hospital (UAB Hospital)
Birmingham, Alabama, 35233-1932
Antonio Di Stasi, MDadistasi@uabmc.edu
Banner MD Anderson Cancer Center
Gilbert, Arizona, 85234-2165
City of Hope Comprehensive Cancer Center - Duarte
Duarte, California, 91010
University of California Los Angeles (UCLA) - David Geffen School of Medicine
Los Angeles, California, 90095
Steven Tsai, MDsctsai@mednet.ucla.edu
UCHealth Cancer Care - Anschutz Medical Campus - University of Colorado Cancer Center
Aurora, Colorado, 80045

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