Mocravimod for Acute Myeloid Leukemia

(MO-TRANS Trial)

Recruiting at 105 trial locations

Overseen By Jens Hasskarl, MD

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Priothera SAS

Must be taking: CsA-based, TAC-based

Must not be taking: Anti-thymocyte globulin, Alemtuzumab

Disqualifiers: Macular edema, Cardiac dysfunction, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

366 Participants Needed

Trial Summary

What is the purpose of this trial?

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

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does mention that certain medications for GvHD prophylaxis are not allowed. It's best to discuss your current medications with the trial team.

Research Team

Marcos DeLima, MD

Principal Investigator

The Ohio State University Comprehensive Cancer Center

Eligibility Criteria

Adults aged 18-75 with Acute Myeloid Leukemia (AML) who are in remission and planning a stem cell transplant from a closely matched donor. They should be relatively healthy, with good organ function and performance status. Those with certain heart, lung, liver or kidney problems, or using specific drugs for graft-versus-host disease prevention are excluded.

Inclusion Criteria

I am fully active or can carry out light work.

My treatment before a transplant was moderately intense or higher.

I will be using CsA or TAC for graft-versus-host disease prevention.

Exclusion Criteria

My liver tests are higher than normal.

My kidneys are not working well (creatinine clearance < 45 mL/min).

I am using ATG, alemtuzumab, or abatacept for graft-versus-host disease prevention.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive mocravimod or placebo orally once per day for 12 months

12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Treatment Details

Interventions

• Mocravimod

Trial Overview The trial is testing Mocravimod as an additional treatment alongside standard care for AML patients undergoing allogeneic hematopoietic stem cell transplantation (Allo-HCT). Participants will either receive Mocravimod or a placebo without knowing which one they're getting.

Participant Groups

Group I: 3mg mocravimod arm Experimental Treatment 1 Intervention

3 mg of mocravimod orally once per day for 12 months

Group II: 1mg mocravimod arm Experimental Treatment 1 Intervention

1 mg of mocravimod orally once per day for 12 months

Group III: Placebo arm Placebo Group 1 Intervention

placebo orally once per day for 12 months

Who Is Running the Clinical Trial?

Priothera SAS

Lead Sponsor

Trials

1

Recruited

250+