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

• ClinicalTrials.gov Identifier: NCT05429632
• Recruitment Status: Recruiting
• First Posted: June 23, 2022
• Last Update Posted: May 6, 2024
• Sponsor: Priothera SAS
• Information provided by (Responsible Party): Priothera SAS

Tracking Information

• First Submitted Date: June 17, 2022
• First Posted Date: June 23, 2022
• Last Update Posted Date: May 6, 2024
• Actual Study Start Date: June 16, 2022
• Estimated Primary Completion Date: November 2025 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: June 17, 2022)

Relapse-free survival (RFS) [ Time Frame: 12 months ]

To compare the efficacy of mocravimod to that of placebo

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: June 17, 2022)

Overall survival (OS) [ Time Frame: 24 months ]

To compare mocravimod's effect on overall survival (OS) to that of placebo

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Mocravimod as Adjunctive and Maintenance Treatment in AML Patients Undergoing Allo-HCT
• 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
• Brief Summary: This is a multi-center, randomized, double-blinded, placebo controlled trial.
• 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 Type: Interventional
• Study Phase: Phase 3

Study Design

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

• Condition: Adult Acute Myeloid Leukemia

Intervention

Drug: mocravimod

S1PR modulator

Study Arms

• Experimental: 3mg mocravimod arm
  3 mg of mocravimod orally once per day for 12 months
  Intervention: Drug: mocravimod
• Experimental: 1mg mocravimod arm
  1 mg of mocravimod orally once per day for 12 months
  Intervention: Drug: mocravimod
• Placebo Comparator: Placebo arm
  placebo orally once per day for 12 months
  Intervention: Drug: mocravimod

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: June 17, 2022): 249
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: November 2025
• Estimated Primary Completion Date: November 2025 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 75 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Malika Souquieres, MSc; +33367510040; malika.souquieres@priothera.com

Contact: Elisabeth Kueenburg, MD; +33367510040; elisabeth.kueenburg@priothera.com

• Listed Location Countries: Brazil, France, Germany, Israel, Italy, Japan, Poland, Romania, Spain, Switzerland, Taiwan, United Kingdom, United States

Administrative Information

• NCT Number: NCT05429632
• Other Study ID Numbers: Priothera SAS
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

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

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Priothera SAS
• Original Responsible Party: Same as current
• Current Study Sponsor: Priothera SAS
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Marcos DeLima, MD; The Ohio State University Comprehensive Cancer Center

• PRS Account: Priothera SAS
• Verification Date: June 2023