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

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ClinicalTrials.gov Identifier: NCT05429632
Recruitment Status : Recruiting
First Posted : June 23, 2022
Last Update Posted : March 24, 2023
Information provided by (Responsible Party):
Priothera SAS

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

Condition or disease Intervention/treatment Phase
Adult Acute Myeloid Leukemia Drug: mocravimod Phase 3

Detailed 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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 249 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: prospective, multicenter, randomized, double-blind, placebo-controlled, and 3-arm parallel group study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized, Double-blind, Placebo-controlled, Multi-center Phase III Study to Evaluate the Efficacy and Safety of Mocravimod as Adjunctive and Maintenance Treatment in Adult AML Patients Undergoing Allogeneic HCT
Actual Study Start Date : September 16, 2022
Estimated Primary Completion Date : August 2025
Estimated Study Completion Date : December 2025

Arm Intervention/treatment
Experimental: 3mg mocravimod arm
3 mg of mocravimod orally once per day for 12 months
Drug: mocravimod
S1PR modulator

Experimental: 1mg mocravimod arm
1 mg of mocravimod orally once per day for 12 months
Drug: mocravimod
S1PR modulator

Placebo Comparator: Placebo arm
placebo orally once per day for 12 months
Drug: mocravimod
S1PR modulator

Primary Outcome Measures :
  1. Relapse-free survival (RFS) [ Time Frame: 12 months ]
    To compare the efficacy of mocravimod to that of placebo

Secondary Outcome Measures :
  1. Overall survival (OS) [ Time Frame: 24 months ]
    To compare mocravimod's effect on overall survival (OS) to that of placebo

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Diagnosis of AML according to the WHO 2022 classification (excluding acute promyelocytic leukemia) and European Leukemia Net (ELN) high risk AML in CR1, intermediate risk AML in CR1, or AML of any risk in CR2.
  • Planned allogeneic HCT from fully matched sibling donor or unrelated donor with no more than 1 antigen mismatch using PBSC graft
  • Planned use of myeloablative conditioning regimen that is expected to result in donor chimerism of > 90%
  • 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, sirolimus, 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 < 60 mL/min by the Cockcroft-Gault formula

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05429632

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Contact: Malika Souquieres, MSc +33367510040 malika.souquieres@priothera.com
Contact: Elisabeth Kueenburg, MD +33367510040 elisabeth.kueenburg@priothera.com

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Sponsors and Collaborators
Priothera SAS
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Principal Investigator: Marcos DeLima, MD The Ohio State University Comprehensive Cancer Center
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Responsible Party: Priothera SAS
ClinicalTrials.gov Identifier: NCT05429632    
Other Study ID Numbers: Priothera SAS
First Posted: June 23, 2022    Key Record Dates
Last Update Posted: March 24, 2023
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No