RECRUITING

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

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Conditions

Adult Acute Myeloid Leukemia

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2022-06-16
Study Completion:2029-11
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05429632

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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
  2. * European Leukemia Net (ELN) high-risk or intermediate-risk AML in CR1, or AML of any risk in CR2, \[CRi\] is also allowable
  3. * 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
  4. * Any conditioning regimen with a Transplant Conditioning Score (TCI) ≥ 1.5
  5. * Planned use of TAC-based GvHD prophylaxis
  6. * age ≥ 18 years and ≤ 75 years
  7. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  1. * Use of CsA, anti-thymocyte globulin (ATG), alemtuzumab, abatacept for GvHD prophylaxis
  2. * Diagnosis of macular edema during screening
  3. * Cardiac/pulmonary/hepatic/renal dysfunction
  4. * 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
  5. * Renal dysfunction with estimated creatinine clearance \< 45 mL/min by the Cockcroft-Gault formula
  6. * Diabetes mellitus
  7. * History or presence of uveitis at screening
  8. * History or diagnosis of macular edema

Contacts and Locations

Study Contact

Malika Souquieres, MSc
CONTACT
+33 (0) 6 40 91 26 76
malika.souquieres@priothera.com
Jens Hasskarl, MD
CONTACT
+41 79 5432099
jens.hasskarl@priothera.com

Principal Investigator

Marcos DeLima, MD
PRINCIPAL_INVESTIGATOR
The Ohio State University Comprehensive Cancer Center

Study Locations (Sites)

University of Alabama Hospital (UAB Hospital)
Birmingham, Alabama, 35233-1932
United States
Banner MD Anderson Cancer Center
Gilbert, Arizona, 85234-2165
United States
City of Hope Comprehensive Cancer Center - Duarte
Duarte, California, 91010
United States
University of California Los Angeles (UCLA) - David Geffen School of Medicine
Los Angeles, California, 90095
United States
Emory University - Winship Cancer Institute (WCI)
Atlanta, Georgia, 30322-1013
United States
University of Kansas Cancer Center
Westwood, Kansas, 66103
United States
Ochsner Medical Center (OMC) - New Orleans
New Orleans, Louisiana, 70121
United States
University of Maryland Medical Center (UMMC)
Baltimore, Maryland, 21201-1544
United States
Massachusetts General Hospital
Boston, Massachusetts, 02114
United States
Henry Ford Cancer Institute
Detroit, Michigan, 48202-2610
United States
Spectrum Health Medical Group (SHMG) - Blood & Marrow Transplant - Adult (BMT)
Grand Rapids, Michigan, 49503
United States
University of Rochester Medical Center (URMC)
Rochester, New York, 14642
United States
Stony Brook University (SBU) - Cancer Center
Stony Brook, New York, 11794-0001
United States
University of Cincinnati Medical Center (University Hospital)
Cincinnati, Ohio, 45267
United States
The Ohio State University Comprehensive Cancer Center (OSUCCC)
Cleveland, Ohio, 44106-1716
United States
Oregon Health & Science University (OHSU) - Knight Cancer Institute
Portland, Oregon, 97239-3098
United States
University of Pennsylvania - Abramson Cancer Center
Philadelphia, Pennsylvania, 19104-4206
United States
Baylor Charles A. Sammons Cancer Center
Dallas, Texas, 75246
United States

Collaborators and Investigators

Sponsor: Priothera SAS

  • Marcos DeLima, MD, PRINCIPAL_INVESTIGATOR, The Ohio State University Comprehensive Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-06-16
Study Completion Date2029-11

Study Record Updates

Study Start Date2022-06-16
Study Completion Date2029-11

Terms related to this study

Additional Relevant MeSH Terms

  • Adult Acute Myeloid Leukemia