Open Actively Recruiting

Phase IIb Placebo-controlled Study of Mocravimod as Adjunctive and Maintenance Treatment in AML Patients in Allo-HSCT

About

Brief Summary

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

Primary Purpose
Treatment
Study Type
Interventional
Phase
Phase II

Eligibility

Gender
All
Healthy Volunteers
No
Minimum Age
18 Years
Maximum Age
75 Years

Inclusion Criteria:

  • Diagnosis of AML (excluding acute promyelocytic leukemia): European Leukemia Net (ELN) high risk AML in CR1, intermediate risk AML in CR1 if MRDpos, or AML of any risk in CR2.
  • Planned allogeneic HSCT from fully matched sibling donor or unrelated donor using PBSC graft
  • Planned use of protocol-suggested myeloablative conditioning regimen
  • Planned use of CsA/MTX or TAC/MTX for 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), post-transplantation cyclophosphamide (PTCY), sirolimus, MMF, abatacept, or any other approved or non-approved medication other than MTX plus CsA or MTX plus TAC

  • Diagnosis of macular edema during screening
  • Cardiac/pulmonary/hepatic/renal dysfunction (conduction blockers, or quinidine)
    • 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 < 60 mL/min by the Cockcroft-Gault formula

Join this Trial

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Study Stats
Protocol No.
22-001054
Category
Hematology-Oncology
Oncology
Contact
Bruck Habtemariam
Location
  • UCLA Westwood
For Providers
NCT No.
NCT05429632
For detailed technical eligibility, visit ClinicalTrials.gov.