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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) = 1.5
  5. Planned use of CsA-based or TAC-based GvHD prophylaxis
  6. age = 18 years and = 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
winshipcancer.emory.edu

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.