RecruitingPhase 3

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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 75 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests mocravimod as an added and ongoing treatment for adults with acute myeloid leukemia (AML), a blood cancer, who are getting a stem cell transplant from a donor. It compares mocravimod with a placebo, a treatment with no active drug. People are assigned by chance, and neither they nor the study team know which treatment they get.

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

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Are 18 to 75 years old.
  • Have AML that meets the study’s diagnosis rules, but not acute promyelocytic leukemia, a type of AML.
  • Have medium- or high-risk AML in first remission, or AML of any risk in second remission. Remission means signs of cancer have gone away; blood counts do not need to be fully back to normal.
  • Plan to get a stem cell transplant from a related or unrelated donor with no more than one tissue-marker mismatch, or from a half-matched donor using stem cells collected from blood.
  • Plan to receive treatment to prepare for transplant with a Transplant Conditioning Score of at least 1.5.
  • Plan to use tacrolimus (TAC) to help prevent graft-versus-host disease, when donor cells attack your body.
  • Are fully active, or can walk and do light work but cannot do heavy physical activity.

Who can't join

  • Use cyclosporine (CsA), anti-thymocyte globulin (ATG), alemtuzumab, or abatacept to prevent donor cells from attacking your body.
  • Have or have ever had macular edema, swelling in the part of the eye used for sharp central vision.
  • Have heart, lung, liver, or kidney function problems.
  • Have liver blood tests called AST or ALT above 2.5 times the upper normal limit, or total bilirubin above 1.5 mg/dL.
  • Have an estimated kidney filtering rate, called creatinine clearance, below 45 mL/min using the study’s calculation.
  • Have diabetes.
  • Have or have ever had uveitis, inflammation inside the eye.

Simplified for readability. The official criteria below are what the study team uses.

Official 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

Study sites (21)

AL

AZ

CA

CO

  • UCHealth Cancer Care - Anschutz Medical Campus - University of Colorado Cancer Center · Aurora, CO 80045More trials in Aurora

FL

GA

IA

KS

LA

MA

MD

MI

NY

OH

OR

PA

TX