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
- University of Alabama Hospital (UAB Hospital) · Birmingham, AL 35233-1932More trials in Birmingham
AZ
- Banner MD Anderson Cancer Center · Gilbert, AZ 85234-2165More trials in Gilbert
CA
- City of Hope Comprehensive Cancer Center - Duarte · Duarte, CA 91010Vaibhav Agrawal, MD · Study contact · vagrawal@coh.orgMore trials in Duarte
- University of California Los Angeles (UCLA) - David Geffen School of Medicine · Los Angeles, CA 90095Steven Tsai, MD · Study contact · sctsai@mednet.ucla.eduMore trials in Los Angeles
CO
- UCHealth Cancer Care - Anschutz Medical Campus - University of Colorado Cancer Center · Aurora, CO 80045More trials in Aurora
FL
- Moffitt Cancer Center · Tampa, FL 33612Asmita Mishra, MD · Study contact · asmita.mishra@moffitt.orgMore trials in Tampa
GA
- Emory University - Winship Cancer Institute (WCI) · Atlanta, GA 30322-1013Edmund Waller, MD · Study contact · ewaller@emory.eduMore trials in Atlanta
IA
- University of Iowa Hospitals and Clinics · Iowa City, IA 52242Kittika Poonsombudlert, MD · Study contact · kittika-poonsombudlert@uiowa.eduMore trials in Iowa City
KS
- University of Kansas Cancer Center · Westwood, KS 66103Haitham Abdelhakim, MD · Study contact · habdelhakim@kumc.eduMore trials in Westwood
LA
- Ochsner Medical Center (OMC) - New Orleans · New Orleans, LA 70121More trials in New Orleans
MA
- Massachusetts General Hospital · Boston, MA 02114More trials in Boston
MD
- University of Maryland Medical Center (UMMC) · Baltimore, MD 21201-1544Jean Yared, MD · Study contact · jyared@umm.eduMore trials in Baltimore
MI
- Henry Ford Cancer Institute · Detroit, MI 48202-2610Shatha Farhan, MD · Study contact · sfarhan1@hfhs.orgMore trials in Detroit
- Spectrum Health Medical Group (SHMG) - Blood & Marrow Transplant - Adult (BMT) · Grand Rapids, MI 49503More trials in Grand Rapids
NY
- University of Rochester Medical Center (URMC) · Rochester, NY 14642Eric Huselton, MD · Study contact · Eric_Huselton@URMC.Rochester.eduMore trials in Rochester
- Stony Brook University (SBU) - Cancer Center · Stony Brook, NY 11794-0001More trials in Stony Brook
OH
- University of Cincinnati Medical Center (University Hospital) · Cincinnati, OH 45267Edward Faber, MD · Study contact · 513-584-4268 · fabered@ucmail.uc.eduMore trials in Cincinnati
- The Ohio State University Comprehensive Cancer Center (OSUCCC) · Cleveland, OH 44106-1716Sarah Wall, MD · Study contact · sarah.wall@uhhospitals.orgMore trials in Cleveland
OR
- Oregon Health & Science University (OHSU) - Knight Cancer Institute · Portland, OR 97239-3098Arpita Gandhi, MD · Study contact · gandhiar@ohsu.eduMore trials in Portland
PA
- University of Pennsylvania - Abramson Cancer Center · Philadelphia, PA 19104-4206More trials in Philadelphia
TX
- Baylor Charles A. Sammons Cancer Center · Dallas, TX 75246Jane Reynolds, MD · Study contact · Jana.Reynolds@BSWHealth.orgMore trials in Dallas