Acute Myeloid Leukemia Clinical Trial
Mocravimod as Adjunctive and Maintenance Treatment in AML Patients Undergoing Allo-HCT
Summary
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).
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 CsA-based or 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 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
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There are 45 Locations for this study
Gilbert Arizona, 85234, United States
Los Angeles California, 90095, United States
New Orleans Louisiana, 70121, United States
Baltimore Maryland, 21201, United States
Grand Rapids Michigan, 49503, United States More Info
Cincinnati Ohio, 45267, United States
Cleveland Ohio, 44106, United States More Info
Portland Oregon, 97239, United States More Info
Philadelphia Pennsylvania, 19104, United States
Dallas Texas, 75246, United States
Sao Paulo , 13083, Brazil
São Paulo , 01327, Brazil
São Paulo , 05403, Brazil More Info
Lille , , France
Paris , , France
Villejuif , , France
Halle , , Germany
Jena , 07747, Germany
Munich , 81377, Germany
Jerusalem , , Israel
San Giovanni Rotondo Foggia, 71013, Italy More Info
Alessandria , 15121, Italy
Ascoli Piceno , 63100, Italy More Info
Firenze , , Italy
Monza , 20900, Italy
Pesaro , 61122, Italy
Nagoya-shi Aichi-Ken, 466-8, Japan
Osaka-shi Osaka-Fu, 545-8, Japan
Shimotsuke-shi Tochigi-Ken, 329-0, Japan
Fukuoka-shi , 812-8, Japan
Hiroshima-shi , 730-8, Japan
Matsuyama-shi , 790-0, Japan
Sapporo-shi , 060-8, Japan
Tokyo , , Japan
Yufu , 87559, Japan
Krakow Aichi-Ken, 30-68, Poland
Katowice Silesia, Siles, Poland More Info
Bucharest , , Romania
Barcelona , 08035, Spain
Barcelona , 8916, Spain
Madrid , , Spain
Madrid , , Spain
Valencia , , Spain More Info
Contact
Basel , , Switzerland
Changhua City , 500, Taiwan
Tainan , 70403, Taiwan
Taipei , 10002, Taiwan
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