MO-TRANS: Phase IIb Placebo-controlled Study of Mocravimod as Adjunctive and Maintenance Treatment in AML Patients in Allo-HSCT

Sponsor

Priothera SAS (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05429632

Collaborator

(none)

249

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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).

Study Design

Study Type:

Interventional

Anticipated Enrollment :

249 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

prospective, multicenter, randomized, double-blind, placebo-controlled, and 3-arm parallel group studyprospective, 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

Anticipated Study Start Date :

Jul 1, 2022

Anticipated Primary Completion Date :

Aug 1, 2025

Anticipated Study Completion Date :

Dec 1, 2025

Arms and Interventions

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

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

Primary Outcome Measures

Relapse-free survival (RFS) [12 months]
To compare the efficacy of mocravimod to that of placebo

Secondary Outcome Measures

Overall survival (OS) [24 months]
To compare mocravimod's effect on overall survival (OS) to that of placebo

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Priothera SAS

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Priothera SAS

ClinicalTrials.gov Identifier:

NCT05429632

Other Study ID Numbers:

Priothera SAS

First Posted:

Jun 23, 2022

Last Update Posted:

Jul 1, 2022

Last Verified:

Jun 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Jul 1, 2022