Status and phase
Conditions
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About
This is a multi-center, randomized, double-blinded, placebo controlled trial.
Full description
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).
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
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
Primary purpose
Allocation
Interventional model
Masking
366 participants in 3 patient groups, including a placebo group
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Central trial contact
Malika Souquieres, MSc; Jens Hasskarl, MD
Data sourced from clinicaltrials.gov
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