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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05429632
Recruitment Status : Recruiting
First Posted : June 23, 2022
Last Update Posted : May 6, 2024
Sponsor:
Information provided by (Responsible Party):
Priothera SAS

Study Description
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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).
Study Design
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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 : June 16, 2022
Estimated Primary Completion Date : November 2025
Estimated Study Completion Date : November 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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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


Eligibility Criteria
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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
Criteria

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
Contacts and Locations
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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


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

Locations
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Sponsors and Collaborators
Priothera SAS
Investigators
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Principal Investigator: Marcos DeLima, MD The Ohio State University Comprehensive Cancer Center
More Information
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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: May 6, 2024
Last Verified: June 2023
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