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Mocravimod

A new clinical trial is exploring the potential of Mocravimod, a drug that may improve outcomes for adult patients with Acute Myeloid Leukemia (AML) who are undergoing allogeneic hematopoietic cell transplantation (HCT). This study aims to evaluate the effectiveness and safety of Mocravimod when used as an additional treatment alongside standard care and as a maintenance therapy following transplantation.

Table of Contents

What is MOCRAVIMOD?

MOCRAVIMOD is a new drug being studied for the treatment of Adult Acute Myeloid Leukemia (AML). AML is a type of blood cancer that affects the bone marrow, where blood cells are produced. This drug is specifically designed to help patients who are undergoing a stem cell transplantation, also known as allogeneic hematopoietic cell transplantation (HCT)[1].

How MOCRAVIMOD Works

MOCRAVIMOD is classified as an S1PR modulator. S1PR stands for Sphingosine-1-phosphate receptor. These receptors play a crucial role in regulating the immune system and cell movement. By modulating these receptors, MOCRAVIMOD may help improve the success of stem cell transplantation and reduce the risk of cancer relapse[1].

Clinical Trial Overview

A large-scale clinical trial is currently underway to evaluate the effectiveness and safety of MOCRAVIMOD. This study is described as a:

  • Multi-center trial: The study is being conducted at multiple hospitals or research centers.
  • Randomized: Patients are randomly assigned to different treatment groups.
  • Double-blinded: Neither the patients nor the doctors directly involved in their care know which treatment each patient is receiving.
  • Placebo-controlled: Some patients will receive a placebo (a harmless substance with no active ingredients) instead of the actual drug.

This type of study design helps ensure that the results are reliable and not influenced by bias[1].

Treatment Arms

The study has three treatment groups, also called “arms”:

  1. 3mg MOCRAVIMOD arm: Patients in this group receive 3 mg of MOCRAVIMOD orally (by mouth) once per day for 12 months.
  2. 1mg MOCRAVIMOD arm: Patients in this group receive 1 mg of MOCRAVIMOD orally once per day for 12 months.
  3. Placebo arm: Patients in this group receive a placebo orally once per day for 12 months.

The purpose of having different dosage groups is to determine the most effective and safe dose of the medication[1].

Expected Outcomes

The researchers are primarily interested in two main outcomes:

  1. Relapse-free survival (RFS): This measures how long patients live without their cancer returning after treatment.
  2. Overall survival (OS): This measures how long patients live overall after starting the treatment.

The study aims to compare these outcomes between patients receiving MOCRAVIMOD and those receiving the placebo[1].

Potential Benefits

If successful, MOCRAVIMOD could offer several benefits for AML patients undergoing stem cell transplantation:

  • Improved success rates of stem cell transplantation
  • Reduced risk of cancer relapse
  • Increased survival time without cancer recurrence
  • Potentially improved overall survival

It’s important to note that these potential benefits are still being studied, and the final results of the clinical trial will provide more definitive information about the effectiveness of MOCRAVIMOD[1].

Aspect Details
Study Type Randomized, double-blind, placebo-controlled, multi-center Phase III study
Drug Mocravimod (S1PR modulator)
Condition Adult Acute Myeloid Leukemia (AML)
Treatment Groups 3mg Mocravimod, 1mg Mocravimod, Placebo
Treatment Duration 12 months
Primary Outcome Relapse-free survival (RFS)
Secondary Outcome Overall survival (OS)
Treatment Context Adjunctive and maintenance treatment for patients undergoing allogeneic HCT

FAQ

  • What is Mocravimod? Mocravimod is a drug classified as an S1PR modulator. It is being studied as a potential treatment for adult patients with Acute Myeloid Leukemia (AML) who are undergoing stem cell transplantation.
  • What is the main goal of this clinical trial? The main goal of this trial is to evaluate the effectiveness and safety of Mocravimod as an additional treatment and maintenance therapy for adult AML patients undergoing allogeneic hematopoietic cell transplantation (HCT).
  • How is the trial designed? This is a multi-center, randomized, double-blind, placebo-controlled trial with three treatment groups. Patients will be randomly assigned to receive either 3mg of Mocravimod, 1mg of Mocravimod, or a placebo, taken orally once per day for 12 months.
  • What are the main outcomes being measured in this trial? The primary outcome being measured is relapse-free survival (RFS), comparing the effectiveness of Mocravimod to that of placebo. A secondary outcome is overall survival (OS), also comparing Mocravimod's effect to that of placebo.
  • How long will patients receive treatment in this trial? Patients in this trial will receive their assigned treatment (Mocravimod or placebo) orally once per day for a period of 12 months.

Ongoing Clinical Trials on Mocravimod

  • Study on Mocravimod for Adults with Acute Myeloid Leukemia Undergoing Stem Cell Transplant

    Recruiting

    1 1
    Investigated drugs:
    France Germany Italy Poland Romania Spain

Glossary

  • Acute Myeloid Leukemia (AML): A type of cancer that affects the blood and bone marrow, characterized by the rapid growth of abnormal white blood cells that interfere with the production of normal blood cells.
  • Allogeneic Hematopoietic Cell Transplantation (HCT): A procedure where a patient receives blood-forming stem cells from a genetically similar, but not identical, donor to replace diseased or damaged bone marrow.
  • S1PR modulator: A type of drug that affects the Sphingosine-1-phosphate receptor, which is involved in various cellular processes including immune cell movement.
  • Relapse-free survival (RFS): The length of time after treatment during which no signs of cancer are found in a person who has received treatment for cancer.
  • Overall survival (OS): The length of time from either the date of diagnosis or the start of treatment for a disease that patients diagnosed with the disease are still alive.
  • Randomized trial: A type of clinical trial where participants are randomly assigned to different treatment groups to compare the effectiveness of different treatments.
  • Double-blind: A study design where neither the participants nor the researchers know which treatment each participant is receiving until after the trial is completed.
  • Placebo-controlled: A study that uses an inactive substance (placebo) in one group to compare its effects with the active treatment being tested.
  • Adjunctive treatment: An additional treatment used together with the primary treatment to assist or improve the effectiveness of the main treatment.
  • Maintenance treatment: Treatment given to help keep cancer from coming back after it has disappeared following the initial therapy.

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