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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Priothera SAS
Study ID
NCT05429632
Phase
PHASE3
Status
Recruiting

Conditions

  • Adult Acute Myeloid Leukemia

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • mocravimod — DRUG
    S1PR modulator

Study Details

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

Key Dates

Start date
Jun 16, 2022
Status verified
Dec 2025
Primary completion
May 31, 2027
Completion
Nov 30, 2029

Study Design

Enrollment
366 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 3mg mocravimod arm
    3 mg of mocravimod orally once per day for 12 months
  • Experimental: 1mg mocravimod arm
    1 mg of mocravimod orally once per day for 12 months
  • Placebo Comparator: Placebo arm
    placebo orally once per day for 12 months

Primary Outcome Measure

Relapse-free survival (RFS) [ Time Frame: 12 months ]

Central Contacts

Locations (21)

FacilityCityStateZIPSite coordinators
University of Alabama Hospital (UAB Hospital)BirminghamAlabama35233-1932
Antonio Di Stasi, MD
Banner MD Anderson Cancer CenterGilbertArizona85234-2165-
City of Hope Comprehensive Cancer Center - DuarteDuarteCalifornia91010
Vaibhav Agrawal, MD
University of California Los Angeles (UCLA) - David Geffen School of MedicineLos AngelesCalifornia90095
Steven Tsai, MD
UCHealth Cancer Care - Anschutz Medical Campus - University of Colorado Cancer CenterAuroraColorado80045-
Moffitt Cancer CenterTampaFlorida33612
Asmita Mishra, MD
Emory University - Winship Cancer Institute (WCI)AtlantaGeorgia30322-1013
Edmund Waller, MD
University of Iowa Hospitals and ClinicsIowa CityIowa52242
Kittika Poonsombudlert, MD
University of Kansas Cancer CenterWestwoodKansas66103
Haitham Abdelhakim, MD
Ochsner Medical Center (OMC) - New OrleansNew OrleansLouisiana70121-
University of Maryland Medical Center (UMMC)BaltimoreMaryland21201-1544
Jean Yared, MD
Massachusetts General HospitalBostonMassachusetts02114-
Henry Ford Cancer InstituteDetroitMichigan48202-2610
Shatha Farhan, MD
Spectrum Health Medical Group (SHMG) - Blood & Marrow Transplant - Adult (BMT)Grand RapidsMichigan49503
Sami Brake, MD
University of Rochester Medical Center (URMC)RochesterNew York14642
Eric Huselton, MD
Stony Brook University (SBU) - Cancer CenterStony BrookNew York11794-0001
Fengshuo Lan, MD
University of Cincinnati Medical Center (University Hospital)CincinnatiOhio45267
Edward Faber, MD
513-584-4268
The Ohio State University Comprehensive Cancer Center (OSUCCC)ClevelandOhio44106-1716
Sarah Wall, MD
Oregon Health & Science University (OHSU) - Knight Cancer InstitutePortlandOregon97239-3098
Arpita Gandhi, MD
University of Pennsylvania - Abramson Cancer CenterPhiladelphiaPennsylvania19104-4206-
Baylor Charles A. Sammons Cancer CenterDallasTexas75246
Jane Reynolds, MD

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