We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Phase IIb Placebo-controlled Study of Mocravimod as Adjunctive and Maintenance Treatment in AML Patients in Allo-HSCT (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 : February 3, 2023
Sponsor:
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 2

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 stem cell transplantation (HSCT).

Layout table for study information
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 IIb Study to Evaluate the Efficacy and Safety of Mocravimod as Adjunctive and Maintenance Treatment in Adult AML Patients Undergoing Allogeneic HSCT
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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): European Leukemia Net (ELN) high risk AML in CR1, intermediate risk AML in CR1 if MRDpos, or AML of any risk in CR2.
  • Planned allogeneic HSCT from fully matched sibling donor or unrelated donor using PBSC graft
  • Planned use of protocol-suggested myeloablative conditioning regimen
  • Planned use of CsA/MTX or TAC/MTX for 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), post-transplantation cyclophosphamide (PTCY), sirolimus, MMF, abatacept, or any other approved or non-approved medication other than MTX plus CsA or MTX plus TAC

  • Diagnosis of macular edema during screening
  • Cardiac/pulmonary/hepatic/renal dysfunction (conduction blockers, or quinidine)

    • 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


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

Locations
Show Show 23 study locations
Sponsors and Collaborators
Priothera SAS
Investigators
Layout table for investigator information
Principal Investigator: Marcos DeLima, MD The Ohio State University Comprehensive Cancer Center
Layout table for additonal information
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: February 3, 2023
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No