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

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

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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