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Mocravimod as Adjunctive and Maintenance Treatment in AML Patients Undergoing Allo-HCT (MO-TRANS)

P

Priothera

Status and phase

Enrolling
Phase 3

Conditions

Adult Acute Myeloid Leukemia

Treatments

Drug: mocravimod

Study type

Interventional

Funder types

Industry

Identifiers

NCT05429632
Priothera SAS

Details and patient eligibility

About

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

Full description

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).

Enrollment

249 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 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
  • European Leukemia Net (ELN) high-risk or intermediate-risk AML in CR1, or AML of any risk in CR2, [CRi] is also allowable
  • 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
  • Any conditioning regimen with a Transplant Conditioning Score (TCI) ≥ 1.5
  • Planned use of CsA-based or TAC-based 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), alemtuzumab, abatacept for GvHD prophylaxis
  • Diagnosis of macular edema during screening
  • Cardiac/pulmonary/hepatic/renal dysfunction
  • 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 < 45 mL/min by the Cockcroft-Gault formula

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

249 participants in 3 patient groups, including a placebo group

3mg mocravimod arm
Experimental group
Description:
3 mg of mocravimod orally once per day for 12 months
Treatment:
Drug: mocravimod
1mg mocravimod arm
Experimental group
Description:
1 mg of mocravimod orally once per day for 12 months
Treatment:
Drug: mocravimod
Placebo arm
Placebo Comparator group
Description:
placebo orally once per day for 12 months
Treatment:
Drug: mocravimod

Trial contacts and locations

75

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Central trial contact

Elisabeth Kueenburg, MD; Malika Souquieres, MSc

Data sourced from clinicaltrials.gov

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