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Mocravimod for Acute Myeloid Leukemia (MO-TRANS Trial)

Phase 3
Recruiting
Led By Marcos DeLima, MD
Research Sponsored by Priothera SAS
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Any conditioning regimen with a Transplant Conditioning Score (TCI) ≥ 1.5
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights

MO-TRANS Trial Summary

This trialtests a medical treatment to see if it is effective & safe to use: volunteers take either the treatment or a dummy pill.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Specific side effects of Mocravimod aren't detailed here but could include typical drug reactions such as nausea, headaches, potential organ inflammation or immune system responses due to the nature of it being an adjunctive treatment in transplant patients.

MO-TRANS Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am fully active or can carry out light work.
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My treatment before a transplant was moderately intense or higher.
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I will be using CsA or TAC for graft-versus-host disease prevention.
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I am between 18 and 75 years old.
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I have been diagnosed with AML, not including acute promyelocytic leukemia.
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I am scheduled for a stem cell transplant from a closely matched donor or a half-matched donor using peripheral blood stem cells.

MO-TRANS Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Relapse-free survival (RFS)
Secondary outcome measures
Overall survival (OS)

MO-TRANS Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: 3mg mocravimod armExperimental Treatment1 Intervention
3 mg of mocravimod orally once per day for 12 months
Group II: 1mg mocravimod armExperimental Treatment1 Intervention
1 mg of mocravimod orally once per day for 12 months
Group III: Placebo armPlacebo Group1 Intervention
placebo orally once per day for 12 months

Find a Location

Who is running the clinical trial?

Priothera SASLead Sponsor
Marcos DeLima, MDPrincipal InvestigatorThe Ohio State University Comprehensive Cancer Center

Media Library

3mg mocravimod arm Clinical Trial Eligibility Overview. Trial Name: NCT05429632 — Phase 3
Acute Myeloid Leukemia Research Study Groups: 3mg mocravimod arm, Placebo arm, 1mg mocravimod arm
Acute Myeloid Leukemia Clinical Trial 2023: 3mg mocravimod arm Highlights & Side Effects. Trial Name: NCT05429632 — Phase 3
3mg mocravimod arm 2023 Treatment Timeline for Medical Study. Trial Name: NCT05429632 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How have patients responded to the 1mg mocravimod regimen?

"Our Power team rates 1mg mocravimod as a 3 on the safety scale, due to evidence from Phase 3 trials and numerous data points that validate its efficacy."

Answered by AI

Is the current research study enlisting individuals aged 45 or older?

"The requirements for being admitted into this trial dictate that prospective patients must be between the ages of 18 and 75. There are 453 trials available to individuals below 18 years old, while 1183 studies accommodate those above 65."

Answered by AI

Are there any medical facilities that have instituted this experiment in North America?

"The ongoing clinical trial encompasses 6 distinguished medical facilities, such as Hospital Clinico Universitario -Universidad de Salamanca in Spain, Rambam Health Care Campus in Isreal and The Chaim Sheba Medical Center at Tel HaShomer. Additionally, there are other locales hosting the same investigation."

Answered by AI

Are recruitment efforts still underway for this investigation?

"As per the clinicaltrials.gov website, this research is actively enlisting candidates. It was initially announced on September 16th 2022 and updated most recently on March 23rd 2023."

Answered by AI

Am I a suitable candidate to partake in this medical experiment?

"In order to participate in this medical trial, a patient must have undergone hematopoietic stem cell transplantation for adult acute myeloid leukemia and be between 18-75 years old. Approximately 249 patients are being enrolled."

Answered by AI

How many individuals are taking part in this experiment?

"Affirmative, according to the clinicaltrials.gov database this experiment is actively enrolling patients. The trial was initially posted on September 16th 2022 and most recently updated on March 23rd 2023. This study seeks 249 participants from 6 separate sites."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Mocravimod as Adjunctive and Maintenance Treatment in AML Patients Undergoing Allo-HCT
2022. "Mocravimod as Adjunctive and Maintenance Treatment in AML Patients Undergoing Allo-HCT". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05429632.
~112 spots leftby Nov 2025
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