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

Status
Active
Cancer Type
Leukemia
Trial Phase
Phase III
Eligibility
18 - 75 Years, Male and Female
Study Type
Treatment
NCT ID
NCT05429632
Protocol IDs
Priothera SAS (primary)
NCI-2022-10700
Study Sponsor
Priothera SAS

Summary

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

Objectives

The purpose of this study is to evaluate the efficacy and safety of mocravimod as an
adjunctive and maintenance treatment in adult acute myeloid leukemia (AML) patients
undergoing allogeneic hematopoietic cell transplantation (HCT).

Eligibility

  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) â?¥ 1.5
  5. Planned use of CsA-based or TAC-based GvHD prophylaxis
  6. age â?¥ 18 years and â?¤ 75 years
  7. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Treatment Sites in Georgia

Winship Cancer Institute of Emory University


1365 Clifton Road NE
Building C
Atlanta, GA 30322
404-778-5180
winshipcancer.emory.edu

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Advancing Cancer Care through Partnerships and Innovation

Georgia CORE is a statewide nonprofit that leverages partnerships and innovation to attract more clinical trials, increase research, and promote education and early detection to improve cancer care for Georgians in rural, urban, and suburban communities across the state.